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Non-invasive Ventilation vs Oxygen Therapy After Extubation Failure

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ClinicalTrials.gov Identifier: NCT03832387
Recruitment Status : Completed
First Posted : February 6, 2019
Results First Posted : May 27, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alberto Belenguer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Respiratory Failure
Interventions Device: Non-invasive mechanical ventilation
Device: Continuous positive airway pressure
Device: Venturi mask
Device: Reservoir mask
Enrollment 77
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Period Title: Overall Study
Started 38 39
Completed 33 32
Not Completed 5 7
Reason Not Completed
Protocol Violation             2             6
EXCLUSION CRITERIA             3             1
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask Total
Hide Arm/Group Description

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Total of all reporting groups
Overall Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  YEARS
Number Analyzed 33 participants 32 participants 65 participants
66
(58 to 76)
62
(49 to 73)
64
(51 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
17
  51.5%
15
  46.9%
32
  49.2%
Male
16
  48.5%
17
  53.1%
33
  50.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Spain Number Analyzed 33 participants 32 participants 65 participants
33 32 65
1.Primary Outcome
Title Rate of Intubation
Hide Description Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy
Time Frame from randomization to 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Number
Unit of Measure: participants
10 23
2.Secondary Outcome
Title Rate of Tracheotomy
Hide Description Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation
Time Frame from randomization to 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
10
  31.3%
3.Secondary Outcome
Title Intensive Care Unit Length of Stay
Hide Description Duration of stay at intensive care unit
Time Frame From intensive care unit admission to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: days
18
(9 to 34)
26
(13 to 36)
4.Secondary Outcome
Title Hospital Length of Stay
Hide Description Duration of stay at hospital
Time Frame From hospital admission to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: days
41
(26 to 68)
44
(30 to 53)
5.Secondary Outcome
Title Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy
Hide Description Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.
Time Frame From randomization to one week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: HOURS
37
(22 to 80)
10
(2 to 24)
6.Secondary Outcome
Title Duration of Global Mechanical Ventilation
Hide Description Duration of mechanical ventilation until unsupported ventilation
Time Frame From start of mechanical ventilation to one month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: days
14
(7 to 22)
14
(7 to 29)
7.Secondary Outcome
Title Rate of Intensive Care Unit Mortality
Hide Description Mortality during intensive care unit stay
Time Frame From intensive care unit admission to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
6
  18.8%
8.Secondary Outcome
Title Rate of Hospital Mortality
Hide Description Mortality during hospital stay
Time Frame From hospital admission to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
14
  42.4%
10
  31.3%
9.Secondary Outcome
Title Rate of 90 Days Mortality
Hide Description Mortality at 90 days after randomization
Time Frame 90 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
13
  39.4%
9
  28.1%
10.Secondary Outcome
Title Rate of Ventilator Associated Pneumonia
Hide Description Percentage of participants with lung infection during intensive care unit stay
Time Frame From start of mechanical ventilation to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
8
  25.0%
11.Secondary Outcome
Title Rate of Urinary Tract Infection
Hide Description Percentage of participants with urinary tract infection during intensive care unit stay
Time Frame From intensive care unit admission to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.2%
7
  21.9%
12.Secondary Outcome
Title Rate of Bacteremia
Hide Description Percentage of participants with blood infection during intensive care unit stay
Time Frame From intensive care unit admission to 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description:

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

Overall Number of Participants Analyzed 33 32
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.1%
3
   9.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-invasive Mechanical Ventilation Venturi Mask
Hide Arm/Group Description

Non-invasive ventilation (NIV) was initiated with progressive levels of inspiratory positive airway pressure and expiratory positive airway pressure until a minimum inspiratory positive airway pressure of 10-15 cmH2O and an expiratory positive airway pressure of 5-6 cmH2O were achieved in the first hour. Continuous positive airway pressure (CPAP) was initiated with a initial positive end-expiratory pressure level was 5 cmH2O, with progressive increases up to 10-15 cmH2O.

The objective pressures were set to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. NIV/CPAP were maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Non-invasive mechanical ventilation

Continuous positive airway pressure

For oxygen therapy were used both a Venturi mask with an fraction of inspired oxygen up to 0.5 (15 L/min) and a reservoir mask connected to a high-flow flowmeter with 30 L/min of O2.

The objective oxygen therapy was to reduce dyspnoea and respiratory mechanics, with an respiratory rate between 25 and 28 bpm. Oxygen therapy was maintained continuously (except for hygiene or oral intake) until the patient exhibited improvement from the clinical and/or gasometric perspective.

Venturi mask

Reservoir mask

All-Cause Mortality
Non-invasive Mechanical Ventilation Venturi Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   14/33 (42.42%)   10/32 (31.25%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-invasive Mechanical Ventilation Venturi Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-invasive Mechanical Ventilation Venturi Mask
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/32 (0.00%) 
Long period of inclusion of patients due to being a single-centre study, strict exclusion criteria; low extubation failure probably due to prolongation of MV until extubation; Lastly, direct use of NIV in eligible patients after extubation failure.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. ALBERTO BELENGUER MUNCHARAZ
Organization: HOSPITAL GENERAL UNIVERSITARIO DE CASTELLÓN
Phone: 96472500
EMail: belengueralberto8@gmail.com
Layout table for additonal information
Responsible Party: Alberto Belenguer, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
ClinicalTrials.gov Identifier: NCT03832387     History of Changes
Other Study ID Numbers: HGCS03
First Submitted: January 24, 2019
First Posted: February 6, 2019
Results First Submitted: February 26, 2019
Results First Posted: May 27, 2019
Last Update Posted: June 4, 2019