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High Flow Nasal Cannulae vs Venturi Mask in Respiratory Failure Due to Pneumonia (HiFlOViP)

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ClinicalTrials.gov Identifier: NCT03515031
Recruitment Status : Unknown
Verified April 2018 by Roberto Cosentini, Papa Giovanni XXIII Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Roberto Cosentini, Papa Giovanni XXIII Hospital

Brief Summary:

The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia.

Inclusion Criteria: Respiratory rate (RR) at rest ≥30 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients).

Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS 2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for hospital-acquired pneumonia.

Intubation Criteria:

MAJOR CRITERIA:

Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation

MINOR CRITERIA (maintained for ≥1h):

Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening.

Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as:

Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population


Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Pneumonia Device: High Flow Nasal Cannula Oxygenation Device: Venturi Mask Oxygenation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: open randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessor will be blind to the treatment allocation
Primary Purpose: Treatment
Official Title: Open Randomized Controlled Clinical Trial Comparing Oxygen Therapy by High Flow Nasal Cannulae and by Venturi Mask in the Treatment of Acute Respiratory Failure Due to Severe Pneumonia (Hi Flow Oxygen vs Venturi Mask In Pneumonia)
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High Flow Nasal Cannula Oxygenation
High Flow Nasal Cannula Oxygenation with a minimum flow ≥ 60L / min, and an FiO2 such as to maintain a SpO2 ≥ 92% for at least 48 hours until clinical stability
Device: High Flow Nasal Cannula Oxygenation
Delivery of humidified and heated (37ºC) high flow oxygen

Active Comparator: Venturi Mask Oxygenation
Venturi Mask Oxygenation, with an FiO2 such as to maintain an SpO2 ≥ 92% for at least 48 hours until clinical stability
Device: Venturi Mask Oxygenation
delivery of high flow oxygen




Primary Outcome Measures :
  1. endotracheal intubation criteria [ Time Frame: Participants will be followed for the duration of hospital stay, for a maximum of 30 days ]

    The primary endpoint is the achievement of the following endotracheal intubation criteria:

    At least one of major criteria Or

    At least 2 or more of the minor criteria maintained for at least 1 consecutive hour:

    MAJOR CRITERIA:

    Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability (Heart Rate ≤ 50 bpm with loss of alertness or Systolic Blood Pressure ≤ 70 mmHg) Need for sedation

    MINOR CRITERIA (observed for ≥ 1 hour):

    Reduction ≥30% of the value of the PaO 2 / FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale (see Appendix II) Persistence or onset of respiratory distress ( severe dyspnea or use of accessories respiratory muscles or paradoxical abdominal motion)



Secondary Outcome Measures :
  1. 30-day mortality after admission [ Time Frame: day 30 ]
    mortality rate at 30 days after admission

  2. improvement of respiratory exchanges compared to baseline [ Time Frame: hospital admission (=day 1), day 2, until the achievement of clinical stability ]
    arterial blood gas evaluation of gas exchange and ventilation

  3. adverse events [ Time Frame: Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    observation adverse events rate

  4. hospital stay [ Time Frame: Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    length of hospital stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female of any ethnic group
  • age greater than or equal to 18 years;
  • respiratory rate (RR) at rest ≥ 30 breaths/minute or presence of respiratory distress (severe - dyspnea at rest or use of accessory respiratory muscles or paradox abdominal movement) PaO 2/ FiO 2 ≤250 during oxygen therapy with Venturi mask with FiO 2 50% administered for at least 60 minutes;
  • diagnosis of pneumonia as the unique cause of acute respiratory failure
  • informed consent obtained from the patient or the closest relative in case of patient's inability to give it.

Exclusion Criteria:

  • other diagnoses (instead of pneumonia) as a cause of acute respiratory failure
  • unstable angina and acute myocardial infarction in place;
  • Acute respiratory acidosis with pH <7.35 and PaCO 2 > 45 mmHg;
  • systolic blood pressure <90 mmHg unresponsive to fluids or with amines
  • severe arrhythmias;
  • epileptic seizures;
  • the degree of vigilance depending on the Kelly scale > 3 (see Appendix II)
  • impaired swallowing, which increases the risk of pneumonia aspiration inability to protect airways
  • craniofacial trauma or burns
  • uncooperative patient
  • presence of open wound (skull, chest, abdomen)
  • respiratory arrest or need for intubation
  • ongoing pregnancy or suspected

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515031


Contacts
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Contact: roberto cosentini, MD +39 338 600 2601 r.cosentini@gmail.com
Contact: andrea duca, MD +39 339 698 0728 andreaducamd@gmail.com

Sponsors and Collaborators
Papa Giovanni XXIII Hospital
Investigators
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Study Director: roberto cosentini, MD ASST Papa Giovanni XXIII, Bergamo, Italy
Publications:

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Responsible Party: Roberto Cosentini, MD, Head of Emergency Room, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT03515031    
Other Study ID Numbers: PapaGiovanniH
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Cosentini, Papa Giovanni XXIII Hospital:
High Flow Nasal Cannula
Venturi mask
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases