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

NCT ID: NCT07019636

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 314 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-10-15

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).

Detailed Description

Weaning from mechanical ventilation is a critical step in the course on an ICU stay. Separation from the ventilator should be done at the earliest possible time, but extubation failure is an adverse event that should be avoided. The most common decision-making strategy regarding weaning and extubation is to combine a daily assessment of the patient's "readiness to wean" and a spontaneous breathing trial before to extubate.

The result of the SBT (passed of failed) is often viewed as a "go - no go" indicator of whether or not patients are ready for extubation, but daily practice indicates that the assessment of the SBT is subjective with a frequent natural tendency for clinicians to keep their patients on the 'safe' side, i.e., considering them as not being ready for extubation. However, the results of the SBT should be interpreted based on the pre-test probability. Conducting a SBT in patients while the pre-test probability of success is high will result in false negatives which are likely to delay the decision of extubation. In addition, a pointless SBT may expose patients to anxiety, air hunger and dyspnea which are poorly detected by caregivers. The hypothesis of the present project is that in patients who are at low risk of extubation failure, a SBT is useless and once readiness to wean criteria are met, direct extubation would increase the proportion of patients successfully extubated within the 24 hours after randomization as compared to extubation after a successful SBT.

Conditions

Weaning From Mechanical Ventilation, Extubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Weaning strategy with direct extubation (no spontaneous breathing trial)

Group Type: EXPERIMENTAL

Weaning strategy with direct extubation (no spontaneous breathing trial)

Intervention Type: PROCEDURE

Patients will be extubated within the 60 minutes following randomization

Weaning strategy with extubation only after a successful spontaneous breathing

Group Type: ACTIVE_COMPARATOR

Weaning strategy with extubation only after a successful spontaneous breathing

Intervention Type: PROCEDURE

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

Interventions

Weaning strategy with direct extubation (no spontaneous breathing trial)

Patients will be extubated within the 60 minutes following randomization

Intervention Type: PROCEDURE

Weaning strategy with extubation only after a successful spontaneous breathing

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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:

1. Respiratory rate < 35 cycles per minute

2. SpO2 >90% with FiO2<40% and PEEP<8 cmH2O

3. RASS score between -2 and +2 with low level or no sedatives

4. No need or low doses of vasopressors

5. Adequate cough

• Inform consent by patient or legal representative or the close relative or emergency inclusion procedure.

Exclusion Criteria

• 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
• Patient under AME

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin DRES, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié Salpêtrière - Assistance Publique Hôpitaux de Paris

Locations

Hôpital Pitié Salpêtrière

Paris, , France

Countries

France

Central Contacts

Martin DRES, Pr

Role: CONTACT

martin.dres@aphp.fr

01 42 16 77 97

Facility Contacts

Martin DRES, Pr

Role: primary

martin.dres@aphp.fr

01 42 16 77 97

Other Identifiers

2025-A00258-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP240912

Identifier Type: -

Identifier Source: org_study_id