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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Extubation Failure
• Intervention / Treatment: Diagnostic test: Observational measurement of Cough Peak Flow and Tidal Volume

• Study Type: Observational
• Enrollment (Estimated): 150

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically ventilated adult patients	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital H+ Queretaro

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: July 27, 2026
• First Submitted That Met QC Criteria: July 27, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Mechanical Ventilation; Tidal Volume; Respiratory Weaning; Cough Peak Flow; Airway Protection
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Diagnostic Techniques, Respiratory System; Respiratory Physiological Phenomena; Respiratory Function Tests; Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Tidal Volume
• Other Study ID Numbers: CEI2026-07/06/V1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No