Postoperative Extubation in Hypoxemic Patients (EPHYRE)

November 12, 2024 updated by: Fondation Hôpital Saint-Joseph

Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial

The objective of this clinical trial is to assess whether early extubation of patients with hypoxemia during the spontaneous breathing trial (SBT) shortens the duration of ventilatory support. The trial will also evaluate the safety of this approach. The key research questions include:

Does early extubation of hypoxemic patients reduce the total duration of ventilatory support (both invasive and non-invasive) by 36 hours? Does early extubation of hypoxemic patients increase the number of ventilator-free days by day 28? Can the safety of early extubation in hypoxemic patients be ensured by confirming no significant differences in rates of reintubation, tracheostomy, or mortality? The trial will compare ventilatory outcomes between two groups: hypoxemic patients who undergo early extubation (hypoxemic extubation group) and those who remain on invasive ventilation until hypoxemia resolves (conventional extubation group).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

International guidelines recommend extubating patients after correction of hypoxemia, meaning if the SpO2 measured during the spontaneous breathing trial is above 92%. However, there is strong rationale for modifying this practice to extubate patients earlier, particularly those presenting with hypoxemia after major surgery, by using alternating non-invasive ventilation (NIV) and high-flow oxygen therapy:

Several studies have found no link between patient oxygenation and extubation success, where outcomes for hypoxemic and non-hypoxemic patients are similar. Isolated hypoxemia thus does not appear to be a predictor of reintubation.

Hypoxemia is very common following major surgery, primarily due to shunts caused by atelectasis. Treatment for these atelectasis includes airway pressurization, bronchial secretion drainage, mobilization, and reducing factors that lead to diaphragmatic dysfunction.

In patients on invasive mechanical ventilation, secretion drainage is impaired, and mobilization to a seated position is more challenging. It has also been shown that diaphragmatic dysfunction occurs with prolonged ventilation. Hypoxemia can therefore be sustained by invasive ventilation, increasing the risk of therapeutic escalation.

Current guidelines do not account for the widespread use of non-invasive assistance techniques (such as high-flow oxygen therapy and non-invasive ventilation) that are now routinely employed in intensive care. These techniques allow for adequate oxygenation with high patient comfort and good tolerance.

Prolonging invasive ventilation in hypoxemic patients, as recommended by guidelines, could lead to associated complications. In contrast, early extubation of patients with hypoxemia may reduce the duration of both invasive and non-invasive ventilation, as well as complications related to prolonged invasive ventilation, without increasing the risk of reintubation.

Compared to continuing mechanical ventilation until hypoxemia is corrected, extubating purely hypoxemic patients and transitioning them to non-invasive ventilation techniques could represent a significant improvement in patient care.

Study Type

Interventional

Enrollment (Estimated)

152

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 Contact

Study Contact Backup

Study Locations

  • France
      • Argenteuil, France, 95107
      • Besançon, France, 25030
        • CHRU De Besancon
        • Contact:
        • Sub-Investigator:
          • Sebastien Pili-Floury
      • Le plessis robinson, France, 92350
        • Marie Lannelongue Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thibaut Genty
      • Montpellier, France, 34090
        • Hôpital Saint Eloi, CHU Montpellier
        • Sub-Investigator:
          • Samir Jaber
        • Contact:
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
        • Contact:
        • Sub-Investigator:
          • Alexy Tran Dinh
      • Paris, France, 75013
        • Chu La Pitie Salpetriere
        • Contact:
        • Sub-Investigator:
          • Antoine Monsel
      • Paris, France, 75015
        • hôpital george Pompidou
        • Contact:
        • Sub-Investigator:
          • Bernard Cholley
      • Paris, France, 75014
        • réanimation polyvalente hopital saint joseph groupe hospitalier Paris saint Joseph
        • Sub-Investigator:
          • Cédric Bruel
        • Contact:
      • Reims, France, 51092
        • CHU de Reims
        • Contact:
        • Sub-Investigator:
          • Salvatore Muccio
      • Saint Denis, France, 93200
        • Centre Cardiologique du Nord
        • Contact:
        • Sub-Investigator:
          • Jean Michel Maillet

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Francophone patient affiliated to a health insurance plan;
  • Patient having granted free, informed and written consent to participate in the study;
  • Patient with hypoxemia defined as SpO2 ≤ 90% under 6 L/min or FiO2 40% during spontaneous breathing trial.

Exclusion Criteria:

  • Presence of hypercapnia at the end of SBT (PaCO2 above 50 mmHg);
  • Presence of severe hypoxemia during SBT defined by SpO2 below 86% under 9 L/min or FiO2 = 50%;
  • Presence of poor clinical tolerance of SBT defined by polypnoea above 30/min, agitation, sweating, hypertension (PAS above 180 mmHg), tachycardia (HR above 140 bpm) or arrhythmia;
  • Presence of an ineffective cough or major bronchial congestion;
  • Patient already included in a type 1 interventional research protocol (RIPH1), modifying the procedure for ventilatory weaning and/or ventilatory support after extubation;
  • Anatomical factors precluding the use of NIV or high-flow oxygen therapy, notably facial or cervico-facial malformations;
  • Tracheostomized patient;
  • History of obstructive ventilatory disorders with indication for NIV post-extubation, chronic obstructive pulmonary disease (COPD) GOLD score III/IV;
  • History of obstructive sleep apnea syndrome with equipment;
  • cardiogenic pulmonary edema;
  • Patient on extracorporeal membrane oxygenation (ECMO) at the time of inclusion;
  • Patient under guardianship or curatorship;
  • Minor patients;
  • Patient deprived of liberty or under court protection;
  • Pregnant or breast-feeding women;
  • Patient in therapeutic limitation with decision not to re-intubate.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hypoxemic extubation group
Randomized patients exhibit relative hypoxemia, defined by an SpO2 ≤ 90% while receiving 6 liters of oxygen or FiO2 of 40%. They must not have severe hypoxemia, defined as an SpO2 < 86% while receiving 9 liters of oxygen or FiO2 of 50%. Additionally, they must not show clinical signs of poor tolerance to the spontaneous breathing trial. Patients randomized to the "hypoxemic extubation group" are extubated despite the presence of relative hypoxemia after one hour of reventilation. Following extubation, a non-invasive oxygenation strategy is initiated, alternating between non-invasive ventilation and high-flow oxygen therapy for a minimum of 24 hours.
Other: early extubation of hypoxemic patients
patient extubated after the spontaneous ventilation trial despite the presence of hypoxemia defined by SpO2 ≤ 90% either in T-piece under 6 L/min, or under FiO2 = 40% if SBT is performed in spontaneous ventilation with minimal inspiratory assistance.
No Intervention: conventional extubation group

Patients in the conventional extubation group also present with relative hypoxemia, defined as an SpO2 ≤ 90% on 6 liters of oxygen or FiO2 of 40% at the time of randomization, but they will only be extubated after correction of this hypoxemia. In practice, patients in the conventional extubation group are not extubated after randomization and continue on invasive ventilation. A new spontaneous breathing trial (SBT) can be performed between 2 and 6 hours after randomization, and if unsuccessful, it may be repeated daily at the discretion of the clinician. Patients in the conventional extubation group will only be extubated when their SpO2 exceeds 90% during an SBT conducted on 6 liters of oxygen or FiO2 of 40%.

After extubation, a non-invasive oxygenation strategy will be initiated, alternating between non-invasive ventilation (NIV) and high-flow oxygen therapy, for a minimum of 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to ventilatory weaning
Time Frame: from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization
Time in hours from randomization to discontinuation of ventilatory support (invasive and non-invasive).
from date of randomisation until the date of cessation of non invasive ventilation or death from any cause, assessed up to 90 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuromyopathie score
Time Frame: day 7of randomisation/day of weaning from non-invasive ventilation
MRC score assessed in each group on day 7 of randomisation and on the day of weaning from non-invasive ventilation.
day 7of randomisation/day of weaning from non-invasive ventilation
death
Time Frame: at 28 and 90 days after randomisation
occuring of death during ICU, hospital management and at day 90
at 28 and 90 days after randomisation
ventilatory support duration between randomization and day 28
Time Frame: from randomisation to day 28
Number of days alive without ventilation (invasive or non-invasive) at day 28 of randomization.
from randomisation to day 28
invasive ventilation duration
Time Frame: from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomization
Time in hours between randomization and cessation of invasive ventilation
from date of randomisation until the date of cessation of invasive ventilation or death from any cause whichever came first assessed up to 90 days after randomization
non invasive ventilation duration
Time Frame: from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
Time in hours between initiation and cessation of non-invasive support after extubation
from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
reintubation rate
Time Frame: up to day 90 after randomisation
Number of patients requiring reintubation
up to day 90 after randomisation
Rate of ventilator-associated pneumonia.
Time Frame: up to day 90 after randomisation
Episodes of ventilator-associated pneumonia according to specific definition
up to day 90 after randomisation
Rate of pneumonia not acquired under invasive mechanical ventilation
Time Frame: up to 90 days after randomisation
Epiodes of pneumonia not acquired during invasive mechanical ventilation
up to 90 days after randomisation
time to mobilisation
Time Frame: from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization
time in hours between randomization and the first mobilisation in the chair
from date of randomisation until the date of the first chair mobilization or death from any cause whichever came first , assessed up to 90 days after randomization
time to ambulation
Time Frame: from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization
time in hours between randomization and first ambulation
from date of randomisation until the date of the first ambulation or death from any cause whichever came first , assessed up to 90 days after randomization
length of stay in ICU
Time Frame: from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
number of day between admission and discharge to ICU
from date of entrance until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in ICU after randomisation
Time Frame: from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
number of day between randomisation and discharge from the ICU
from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital after randomisation
Time Frame: from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
Time in days from randomisation to hospital discharge
from date of randomisation until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
length of stay in hospital
Time Frame: from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization
number of day between admission to discharge of hospital
from date of admission until the date of hospital discharge or death from any cause whichever came first assessed up to 52 weeks after randomization

Collaborators and Investigators

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

Sponsor

Fondation Hôpital Saint-Joseph

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 (Estimated)

November 18, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

October 17, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A00535-42

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.

Clinical Trials on Hypoxemia

Clinical Trials on early extubation of hypoxemic patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe