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Search / Trial NCT06688487

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

Extubation Hypoxemia Postoperative Respiratory Complication Weaning Facilitative Non Invasive Strategy

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported