Clinical trial NCT06688487: Postoperative Extubation in Hypoxemic Patients
Official title: Early Postoperative Extubation in Hypoxemic ICU Patients: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypoxemia
Extubation
Postoperative Respiratory Complication
Keywords: extubation
hypoxemia
postoperative respiratory complication
weaning
facilitative non invasive strategy
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time to ventilatory weaning
timeFrame: 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 outcomes:
measure: neuromyopathie score
timeFrame: day 7of randomisation/day of weaning from non-invasive ventilation
measure: death
timeFrame: at 28 and 90 days after randomisation
measure: ventilatory support duration between randomization and day 28
timeFrame: from randomisation to day 28
measure: invasive ventilation duration
timeFrame: 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
measure: non invasive ventilation duration
timeFrame: from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days
measure: reintubation rate
timeFrame: up to day 90 after randomisation
measure: Rate of ventilator-associated pneumonia.
timeFrame: up to day 90 after randomisation
measure: Rate of pneumonia not acquired under invasive mechanical ventilation
timeFrame: up to 90 days after randomisation
measure: time to mobilisation
timeFrame: 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
measure: time to ambulation
timeFrame: 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
measure: length of stay in ICU
timeFrame: 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
measure: length of stay in ICU after randomisation
timeFrame: from randomisation until the date of discharge to ICU or death from any cause whichever came first assessed up to 52 weeks after randomization
measure: length of stay in hospital after randomisation
timeFrame: 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
measure: length of stay in hospital
timeFrame: 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
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: centre hospitalier Victor Dupouy
city: Besançon
country: France
facility: CHRU de Besançon
city: Le plessis robinson
country: France
facility: Marie Lannelongue Hospital
city: Montpellier
country: France
facility: Hôpital Saint Eloi, CHU Montpellier
city: Paris
country: France
facility: CHU la pitié salpêtrière
city: Paris
country: France
facility: CHU la pitié salpêtrière
city: Paris
country: France
facility: CHU la pitié Salpêtrière
city: Paris
country: France
facility: Institut mutualiste Montsouris
city: Paris
country: France
facility: réanimation polyvalente hopital saint joseph groupe hospitalier Paris saint Joseph
city: Paris
country: France
facility: hôpital george Pompidou
city: Reims
country: France
facility: CHU de Reims
city: Saint Denis
country: France
facility: Centre Cardiologique Du Nord
Study officials:
References:
citation: Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
citation: Quintard H, l'Her E, Pottecher J, Adnet F, Constantin JM, De Jong A, Diemunsch P, Fesseau R, Freynet A, Girault C, Guitton C, Hamonic Y, Maury E, Mekontso-Dessap A, Michel F, Nolent P, Perbet S, Prat G, Roquilly A, Tazarourte K, Terzi N, Thille AW, Alves M, Gayat E, Donetti L. Experts' guidelines of intubation and extubation of the ICU patient of French Society of Anaesthesia and Intensive Care Medicine (SFAR) and French-speaking Intensive Care Society (SRLF) : In collaboration with the pediatric Association of French-speaking Anaesthetists and Intensivists (ADARPEF), French-speaking Group of Intensive Care and Paediatric emergencies (GFRUP) and Intensive Care physiotherapy society (SKR). Ann Intensive Care. 2019 Jan 22;9(1):13. doi: 10.1186/s13613-019-0483-1.
citation: Perkins GD, Mistry D, Gates S, Gao F, Snelson C, Hart N, Camporota L, Varley J, Carle C, Paramasivam E, Hoddell B, McAuley DF, Walsh TS, Blackwood B, Rose L, Lamb SE, Petrou S, Young D, Lall R; Breathe Collaborators. Effect of Protocolized Weaning With Early Extubation to Noninvasive Ventilation vs Invasive Weaning on Time to Liberation From Mechanical Ventilation Among Patients With Respiratory Failure: The Breathe Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1881-1888. doi: 10.1001/jama.2018.13763.