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

NCT07737483 | Not Yet Recruiting

• 1 other identifier: CEI2026-07/06/V1
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Extubation Failure

Keywords

Cough Peak Flow; Mechanical Ventilation; Intensive Care Unit; Airway Protection; Tidal Volume; Respiratory Weaning

Outcome Measures

Primary Outcomes (1)

• Extubation failure

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

  72 hours following the removal of the endotracheal tube

Study Arms (1)

Mechanically ventilated adult patients

Diagnostic Test: Observational measurement of Cough Peak Flow and Tidal Volume

Interventions

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).

Mechanically ventilated adult patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients receiving invasive mechanical ventilation who successfully complete a spontaneous breathing trial and are considered clinically ready for planned extubation. Participants are recruited consecutively from participating tertiary-care intensive care units.

You may qualify if:

• Adult patients (≥18 years) admitted to the ICU who received invasive mechanical ventilation for \>24 hours and successfully completed a Spontaneous Breathing Trial (SBT).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

MeSH Terms

Interventions

Tidal Volume

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 30, 2026

Record last verified: 2026-07