Direct Extubation Versus Extubation After a Spontaneous Breathing Trial in Patients at Low Risk of Extubation Failure

NCT07019636 | Not Yet Recruiting

• 2 other identifiers: APHP2409122025-A00258-41
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled open label trial aims at comparing a weaning strategy including a spontaneous breathing trial as a prerequisite for extubation to a weaning strategy without a spontaneous breathing trial (direct extubation) in patients with readiness to be weaned criteria and considered at low risk of extubation failure. The main endpoint will be the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful spontaneous breathing trial (SBT).

Conditions

Weaning From Mechanical Ventilation, Extubation

Keywords

Weaning; Mechanical ventilation; Extubation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.

  The rate of patients extubated within the 24 hours after randomization and who will remain free from mechanical ventilation until 72 hours.

  From Day 1 to Day 3

Secondary Outcomes (14)

• Occurrence of post extubation acute respiratory failure

  Within 28 days after randomization

• Occurrence of reintubation

  Within 28 days after randomization

• Unplanned use of non-invasive ventilation or high flow nasal oxygen

  Within 28 days after randomization

• Duration of weaning process from randomization until successful extubation

  Within 28 days after randomization

• Total duration of invasive mechanical ventilation from intubation until successful extubation

  Within 28 days after randomization

Study Arms (2)

Weaning strategy with direct extubation (no spontaneous breathing trial)

EXPERIMENTAL

Procedure: Weaning strategy with direct extubation (no spontaneous breathing trial)

Weaning strategy with extubation only after a successful spontaneous breathing

ACTIVE COMPARATOR

Procedure: Weaning strategy with extubation only after a successful spontaneous breathing

Interventions

Weaning strategy with direct extubation (no spontaneous breathing trial) PROCEDURE

Patients will be extubated within the 60 minutes following randomization

Weaning strategy with direct extubation (no spontaneous breathing trial)

Weaning strategy with extubation only after a successful spontaneous breathing PROCEDURE

Patients will undergo a spontaneous breathing trial and will be extubated only in case of successful spontaneous breathing

Weaning strategy with extubation only after a successful spontaneous breathing

Eligibility Criteria

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

You may qualify if:

• Age older than 18 years and \< 65 years old
• Nasal or oral intubation longer than 24 hours and less than 4 days
• Satisfaction to each following weaning readiness criteria:
• Respiratory rate \< 35 cycles per minute
• SpO2 \>90% with FiO2\<40% and PEEP\<8 cmH2O
• RASS score between -2 and +2 with low level or no sedatives
• No need or low doses of vasopressors
• Adequate cough

You may not qualify if:

• Risk factor for extubation failure as defined by any of the following criteria:
• Chronic cardiac disease (left ejection fraction below 45%, documented history of cardiogenic pulmonary edema, permanent atrial fibrillation).
• Chronic respiratory disease (severe COPD, documented restricted lung disease or obesity-hypoventilation syndrome)
• Body mass index \> 30 kg/m2
• Airway patency problems, including high risk of developing laryngeal edema, inability to deal with respiratory secretions, brain injury, documented swallowing disorders
• Tracheostomy
• Underlying chronic neuromuscular disease
• Do not resuscitate orders
• Pregnant or lacting woman
• Patient under guardianship
• Patient without healthcare insurance
• Refusal to participate and sign the written consent
• Patients with traumatic brain injury
• Post surgery patients
• Patients included in another interventional trial that may have an impact on the evaluation criteria of the present study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Study Officials

• Martin DRES, Pr

  Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin DRES, Pr

CONTACT

01 42 16 77 97; martin.dres@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)