Postoperative Extubation in Hypoxemic Patients

NCT06688487 | Not Yet Recruiting

• 1 other identifier: 2024-A00535-42
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 12

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).

Conditions

Hypoxemia; Extubation; Postoperative Respiratory Complication

Keywords

extubation; hypoxemia; postoperative respiratory complication; weaning; facilitative non invasive strategy

Outcome Measures

Primary Outcomes (1)

• time to ventilatory weaning

  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 Outcomes (14)

• neuromyopathie score

  day 7of randomisation/day of weaning from non-invasive ventilation

• death

  at 28 and 90 days after randomisation

• ventilatory support duration between randomization and day 28

  from randomisation to day 28

• invasive ventilation duration

  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

  from date of extubation until the date of cessation of non invasive ventilation strategy or date of reintubation assessed up to 90 days

Study Arms (2)

hypoxemic extubation group

EXPERIMENTAL

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

conventional extubation group

NO INTERVENTION

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.

Interventions

early extubation of hypoxemic patients OTHER

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.

hypoxemic extubation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (12)

centre hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

CHRU de Besançon

Besançon, 25030, France

Location

Marie Lannelongue Hospital

Le Plessis-Robinson, 92350, France

Location

Hôpital Saint Eloi, CHU Montpellier

Montpellier, 34090, France

Location

CHU la pitié salpêtrière

Paris, 75013, France

Location

CHU la pitié salpêtrière

Paris, 75013, France

Location

CHU la pitié Salpêtrière

Paris, 75013, France

Location

Institut mutualiste Montsouris

Paris, 75014, France

Location

réanimation polyvalente hopital saint joseph groupe hospitalier Paris saint Joseph

Paris, 75014, France

Location

hôpital george Pompidou

Paris, 75015, France

Location

CHU de Reims

Reims, 51092, France

Location

Centre Cardiologique Du Nord

Saint-Denis, 93200, France

Location

Related Publications (3)

• 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.

  PMID: 25980660 BACKGROUND

• 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.

  PMID: 30671726 BACKGROUND

• 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.

  PMID: 30347090 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thibaut GENTY, M.D

CONTACT

0140942260; t.genty@gphsj.fr

Francois GJ STEPHAN, M.D; Ph.D

CONTACT

0140948580; f.stephan@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 14, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)