Airway Occlusion Pressure Derived Parameters During Spotaneous Breathing Trial for Predicting Extubation Failure

NCT07786519 | Completed

• 1 other identifier: 35RC23_9774_04
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 4

Brief Summary

Weaning from invasive mechanical ventilation (IMV) is a critical stage of the intensive care unit (ICU) stay. Premature IMV discontinuation may expose patients to substantial cardiopulmonary stress, whereas prolonged weaning increases exposure to complications associated with IMV, including ventilator-associated pneumonia (VAP), diaphragmatic muscle atrophy, and barotrauma. Extubation failure, defined as the need for reintubation within 48-72 h after extubation, occurs in approximately 10-15% of patients reaching 20% in high-risk patients including factors of age \>65 years, chronic cardiac or respiratory disease, IMV duration \>7 days. Extubation failure is associated with substantial morbidity and mortality, with reported hospital mortality rates up to 25-50%, as well as prolonged ICU length of stay and increased healthcare costs. Modern ventilators provide simple, non-invasive access to two complementary physiological indices: the airway occlusion pressure at 100 ms (P0.1), a surrogate of central respiratory drive, and the change in inspiratory pressure during an occlusion maneuver (ΔPocc), a marker of the overall inspiratory effort. This study assesses the predictive value of P0.1 and ΔPocc measured before and during an SBT for predicting reintubation within 3 days after extubation.

Conditions

Weaning Mechanical Ventilation

Keywords

ICU; MEchanical ventilation

Outcome Measures

Primary Outcomes (1)

• Reintubation rate within 3 days after extubation

  Number of patients requiring reintubation within 3 days following extubation

  3 days following extubation

Secondary Outcomes (5)

• Reintubation rate within 2 days after extubation

  2 days following extubation

• Reintubation rate within 7 days after extubation

  7 days following extubation

• ICU mortality

  From ICU admission to ICU discharge or death, assessed up to 60 days

• ICU length of stay

  Between admission to and discharge from the ICU, assessed up to 60 days

• Hospital length of stay

  From ICU admission to hospital discharge, assessed up to 90 days

Study Arms (1)

Patients with mechanical ventilation elligible for weaning

Conducting a systematic measurement of respiratory effort markers during a weaning trial with inspiratory support during the stay in ICU

Eligibility Criteria

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

Study Population

The study was conducted in four critical care units in the Brittany region of France over a 12-month period, using the ventilators available at each center without specific selection, to best reflect usual clinical practices: a tertiary academic surgical ICU at Rennes University Hospital (30 beds) and three general ICUs at Saint-Brieuc Hospital (21 beds), Saint-Malo Hospital (15 beds), and Vannes Hospital (20 beds).

You may qualify if:

• Adult patients meeting all the weaning criteria set out in the consensus of the International Conference on Weaning:
• Duration of mechanical ventilation prior to the first weaning trial \> 24 hours
• Respiratory rate ≤ 35 breaths/min,
• Adequate oxygenation defined as SpO₂ ≥ 90% with FiO₂ ≤ 0.4 or PaO₂/FiO₂ ≥ 150 mm Hg with PEEP ≤ 8 cmH₂O,
• Adequate cough reflex,
• A conscious patient who is responsive to commands and has a RASS (Richmond Agitation Sedation Scale) score between +1 and -2
• Haemodynamically stable without vasopressors or on a minimal dose (noradrenaline \<0.1 µg/kg/min)
• Patient informed about the study and expressing no objection to participating

You may not qualify if:

• Patients with neurological injury and a Glasgow Motor Score of ≤ M5
• Decision not to reintubate in the event of extubation failure
• Adults subject to legal protection (judicial protection, curatorship, guardianship), and persons deprived of their liberty

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (4)

CHU de Rennes

Rennes, France

Location

Centre hospitalier de Saint Brieuc

Saint-Brieuc, France

Location

Centre hospitalier de Saint Malo

St-Malo, France

Location

Centre Hospitalier Bretagne Atlantique

Vannes, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 26, 2026
• Study Start: April 17, 2024
• Primary Completion: April 17, 2025
• Study Completion: September 3, 2025
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (4)