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

ConditionExtubation Failure

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorHospital H+ Queretaro

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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).

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Mechanically ventilated adult patients1 intervention

Trial outcomes

Primary outcomes

Extubation failure

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

Time frame

72 hours following the removal of the endotracheal tube

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital H+ Queretaro

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: