Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational measurement of Cough Peak Flow and Tidal Volume.
- Who it may be relevant to
- Registry conditions: Extubation Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes in the ICU: A Prospective Blinded Cohort Study
Overview
This study aims to prospectively validate the diagnostic accuracy of an effort-stratified Cough Peak Flow (CPF) decision algorithm for predicting extubation failure, maintaining strict blinding of the clinical team. The model classifies patients by neurological status and uses an effort-based approach, including a "Gray Zone" (40-59 L/min) managed by tidal volume evaluation.
Interventions
- Diagnostic test Observational measurement of Cough Peak Flow and Tidal Volume
Patients undergo standardized CPF and pre-cough tidal volume (VT) measurements prior to extubation. Measurements are stratified by cooperation level (Voluntary vs. Reflex).
Primary outcome measures
- Extubation failure [Time frame: 72 hours following the removal of the endotracheal tube]
Eligibility criteria
Inclusion criteria
- Adult patients (≥18 years) admitted to the ICU who received invasive mechanical ventilation for >24 hours and successfully completed a Spontaneous Breathing Trial (SBT).
Exclusion criteria
- Prior indication for tracheostomy (e.g., severe maxillofacial trauma, upper airway obstruction).
- Self-extubation or accidental extubation.
- Decision to withhold or withdraw life-sustaining treatments.
- Severe primary neuromuscular diseases.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07737483 · CEI2026-07/06/V1