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NCT Number: NCT07786519

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

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.

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Key information

Conditions

Weaning Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes, Rennes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Reintubation rate within 3 days after extubation

    Time frame: 3 days following extubation

    Number of patients requiring reintubation within 3 days following extubation

Secondary outcomes

  1. Reintubation rate within 2 days after extubation

    Time frame: 2 days following extubation

    Number of patients requiring reintubation within 2 days following extubation

  2. Reintubation rate within 7 days after extubation

    Time frame: 7 days following extubation

    Number of patients requiring reintubation within 7 days following extubation

  3. ICU mortality

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

    Number of patients who died during the stay in ICU

  4. ICU length of stay

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

    the length of time between admission to and discharge from the intensive care unit

  5. Hospital length of stay

    Time frame: From ICU admission to hospital discharge, assessed up to 90 days

    The length of time between admission to the ICU and discharge from the hospital

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

The Predictive Value of Airway Occlusion Pressure Derived Parameters During Spontaneous Breathing Trial on Successful Weaning From Mechanical Ventilation

Acronym: Weaning-POP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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