Postoperative Extubation in Hypoxemic Patients
Launched by FONDATION HÔPITAL SAINT-JOSEPH · Nov 12, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether taking patients off the ventilator earlier—known as early extubation—can help those with low oxygen levels (hypoxemia) recover faster after surgery. The researchers want to find out if this approach can shorten the total time patients need to be on breathing support and if it leads to more days without needing the ventilator by the time they reach day 28. They will also check if early extubation is safe, meaning they will look for any serious problems like needing to go back on the ventilator, having a tracheostomy (a small opening in the windpipe for breathing), or experiencing death.
To be eligible for this trial, patients must be able to understand and agree to participate, have low oxygen levels defined as a certain measurement, and be part of a health insurance plan. However, there are some important exclusions, such as patients with severe breathing difficulties or certain medical conditions. Participants can expect to be grouped based on whether they receive early extubation or stay on the ventilator longer. This research is not yet recruiting participants, but it aims to help improve care for patients who struggle with low oxygen after surgery.
Gender
ALL
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.
About Fondation Hôpital Saint Joseph
Fondation Hôpital Saint-Joseph is a dedicated clinical trial sponsor committed to advancing healthcare and improving patient outcomes through innovative research. Located in a reputable healthcare institution, the foundation collaborates with healthcare professionals and researchers to conduct high-quality clinical trials across various medical fields. By fostering a culture of scientific excellence and patient-centered care, Fondation Hôpital Saint-Joseph aims to contribute valuable insights to the medical community and enhance the quality of treatments available to patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Argenteuil, , France
Saint Denis, , France
Paris, , France
Reims, , France
Besançon, , France
Paris, , France
Le Plessis Robinson, , France
Montpellier, , France
Paris, , France
Paris, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported