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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07737483

Enrollment

150

Registered

2026-07-30

Start date

2026-07-01

Completion date

2026-11-30

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extubation Failure

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTObservational 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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Extubation failure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026