Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes

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.

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Key information

Conditions

Extubation Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

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.

Treatment and study plan

Observational measurement of Cough Peak Flow and Tidal Volume

Diagnostic Test

Patients undergo standardized CPF and pre-cough tidal volume (VT) measurements prior to extubation. Measurements are stratified by cooperation level (Voluntary vs. Reflex).

Primary outcomes

Extubation failure

Time frame: 72 hours following the removal of the endotracheal tube

Defined as reintubation or the need for rescue Non-Invasive Ventilation (NIV) within 72 hours post-extubation

Sponsors and collaborators

Lead sponsor

Hospital H+ Queretaro

Other

Registry information

Official study title

Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes in the ICU: A Prospective Blinded Cohort Study

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 30, 2026
Registry last updated: Jul 30, 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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