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Post-extubation High-flow Nasal Oxygen for Preventing Extubation Failure

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ClinicalTrials.gov Identifier: NCT03361683
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

Patients intubated due to acute respiratory failure have a high risk of infectious complications, airway injuries and multiple organic failure, so performing a successful extubation from mechanical ventilation is key. Between 10 and 20% of patients develop extubation failure, which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. High-flow nasal oxygen therapy delivers heated, humidified air at flows up to 60L/min, and an oxygen concentration close to 100%, providing a fresh air reservoir at the naseo-pharyngeal level, evening out the peak inspiratory flow rate of the patient, improving air conductance, promoting secretion management, increasing end-expiratory lung volume, and applying a positive end-expiratory pressure. Such effects result in decreased breathing work, dyspnea relief, improved use tolerance, increased oxygenation, and lower fraction of inspired oxygen in patients with hypoxemic respiratory failure. High-flow oxygen therapy has recently been described to decrease extubation failure in a group of patients classified with low failure risk, in comparison to Venturi mask, and it was not inferior to non-invasive mechanical ventilation in high risk patients. However, it is worth pointing out that a large percentage of the patients included in such studies did not develop acute respiratory failure primarily.

Given the beneficial effects described above, the investigators hypothesize that high-flow nasal oxygen therapy decreases the risk of extubation failure in a group of patients that required invasive mechanical ventilation due to acute hypoxemic respiratory failure.


Condition or disease Intervention/treatment Phase
Extubation Failure Device: High-flow nasal oxygen Device: Venturi mask Not Applicable

Detailed Description:

Intubated patients recovering from acute hypoxemic respiratory failure who have passed a spontaneous breathing trial will be included in the study. Following extubation, patients will be randomized assigned to one of two study groups. Heart rate, breathing rate, median arterial pressure, FiO2, SpO2, and dyspnea and comfort levels will be measured at defined intervals after extubation (basal, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours). An arterial blood gas test will be performed 60 minutes and 24 hours after extubation. The number of patients fulfilling certain preset criteria regarding extubation failure will be determined.

Extubation failure shall be defined as the need for using invasive mechanical ventilation again within two days following extubation based on the criteria below:

  • Breathing rate over 25 breaths per minute for more than two hours.
  • Heart rate above 140 beats per minute or with a sustained increase or decrease greater than 20%.
  • Clinical data showing fatigue of the respiratory muscles or an increase in breathing work.
  • SaO2 <90%; PaO2 <80 mmHg with a FiO2 > 50%.
  • Hypercapnia (PaCO2 >45 mmHg or >20% compared to the value before extubation) with a pH below 7.33.

Patients who do not fulfill the extubation failure criteria after the first 48 hours of admission may receive extra supplementary oxygen through any device (e.g., nasal cannula, face mask, reservoir mask, etc.). Every day, SpO2 will be measured and the moment when the patient reaches SpO2 >94% with no need for oxygen will be determined.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: High-flow nasal oxygen
Randomized patients will receive oxygen through a high flow nasal device capable of delivering humidified, heated air at an output rate of 40 L/min
Device: High-flow nasal oxygen
Randomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min
Active Comparator: Conventional oxygen
Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min
Device: Venturi mask
Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min



Primary Outcome Measures :
  1. Post-extubation failure [ Time Frame: First 48 hours ]
    Number of patients with extubation failure criteria in each group


Secondary Outcome Measures :
  1. PaO2/FiO2 Ratio Record. [ Time Frame: Post-extubation period and up to 48 hours later. ]
    An arterial blood gas test will be performed once the high-flow oxygen or Venturi mask is placed.

  2. Determination of FiO2 Requirements. [ Time Frame: Post-extubation period and up to 48 hours later. ]
    Assessment of FiO2 requirements at the time of extubation (when high-flow oxygen or Venturi mask is placed) and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, and 48 hours. The aim is to maintain SpO2 levels > 94% with the minimal FiO2 possible.

  3. Respiratory Rate Record at Defined Intervals. [ Time Frame: Post-extubation period and up to 48 hours later. ]
    Quantification of respiratory rate at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.

  4. Heart Rate Record at Defined Intervals. [ Time Frame: Post-extubation period and up to 48 hours later. ]
    Quantification of heart rate at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.

  5. Mean Arterial Pressure Record at Defined Intervals. [ Time Frame: Post-extubation period and up to 48 hours later. ]
    Quantification of mean arterial pressure at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.

  6. Treatment Comfort Assessment by means of a Visual Analogue Scale at Defined Intervals. [ Time Frame: Post-extubation period and up to 48 hours later. ]

    To record patient comfort by means of a Visual Analogue Scale tool at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.

    Visual Analogue Scale range (0 = better to 10 = worse).


  7. Dyspnea Assessment by means of a Visual Analog Scale at Defined Intervals. [ Time Frame: Post-extubation period and up to 48 hours later. ]

    To measure the level of dyspnea by means of a Visual Analogue Scale tool at the time of placement high-flow oxygen or Venturi mask and then at 60 minutes, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours and 48 hours.

    Visual Analogue Scale range (0 = better to 10 = worse).


  8. Number of Days Requiring Oxygen after Successful Extubation [ Time Frame: Post-extubation period and up to 14 days later. ]
    After successful extubation, the level of SpO2 will be measured on a daily basis, recording the time when a level of SpO2> 94% is reached by the patient without the use of supplemental oxygen.

  9. Number of Days Spent in the ICU after Extubation. [ Time Frame: Post-extubation period and up to 28 days later. ]
    There will be quantified the total length of stay in the ICU after extubation.

  10. Days Spent in the Hospital After Extubation. [ Time Frame: Post-extubation period and up to 28 days later ]
    There will be quantified the total length of stay in the hospital after extubation.

  11. Number of Deaths in the ICU after Extubation. [ Time Frame: Post-extubation period and up to 28 days later ]
    There will be quantified the number of patients deceased in each group

  12. Number of Deaths in the Hospital after Extubation. [ Time Frame: Post extubation period and up to 28 days later. ]
    There will be quantified the number of patients deceased in each group



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

Inclusion Criteria:

Hypoxemic acute respiratory failure

Invasive mechanical ventilation for at least 48 hours

Successful Spontaneous Breathing Trial

Exclusion Criteria:

Immediate indication for invasive mechanical ventilation

Immediate indication for non-invasive mechanical ventilation

Self-extubation

One or more failed Spontaneous Breathing Trial

Chronic respiratory failure

Neuromuscular diseases

Tracheostomy.

Nasal cavity pathology

Facial surgery

Failure to authorize the informed consent


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): NCT03361683


Contacts
Contact: Jose de Jesus Rodriguez-Andoney, MD (+52) - (1- 5554870900) andoneyjjr@hotmail.com
Contact: Guillermo Dominguez-Cherit, MD (+52) - (1- 5554870900) g.dominguez.cherit@gmail.com

Locations
Mexico
National Institute of Medical Science and Nutrition Salvador Zubirán, Recruiting
Mexico, Mexico, 14080
Contact: Jose de Jesus Rodriguez-Andoney, MD    (+52) - (1- 5554870900)    andoneyjjr@hotmail.com   
Contact: Guillermo Dominguez-Cherit, MD    (+52) - (1- 5554870900)    g.dominguez.cherit@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
Principal Investigator: Jose de Jesus Rodriguez-Andoney, MD National Institute of Medical Science and Nutrition Salvador Zubirán

Publications of Results:

Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03361683     History of Changes
Other Study ID Numbers: REF-1350
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
High-Flow nasal oxygen