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

August 6, 2019 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Post-extubation High-flow Nasal Oxygen vs. Conventional Oxygen in Patients Recovered From Acute Hypoxemic Respiratory Failure for Preventing Extubation Failure

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 primary acute hypoxemic respiratory failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intubated patients recovering from primary 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

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico, Mexico, 14080
        • National Institute of Medical Science and Nutrition Salvador Zubirán,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hypoxemic primary 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-extubation failure
Time Frame: First 48 hours
Number of patients with extubation failure criteria in each group
First 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-extubation period and up to 48 hours later.
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.
Post-extubation period and up to 48 hours later.
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.
Post-extubation period and up to 48 hours later.
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.
Post-extubation period and up to 48 hours later.
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.
Post-extubation period and up to 48 hours later.
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).
Post-extubation period and up to 48 hours later.
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).
Post-extubation period and up to 48 hours later.
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.
Post-extubation period and up to 14 days later.
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.
Post-extubation period and up to 28 days later.
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.
Post-extubation period and up to 28 days later
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
Post-extubation period and up to 28 days later
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
Post extubation period and up to 28 days later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Zubiran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 30, 2019

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REF-1350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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