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

N/ANot Yet RecruitingNCT07737483

Hospital H+ Queretaro150 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Extubation Failure

Interventions

Observational measurement of Cough Peak Flow and Tidal VolumeDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

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

Data from ClinicalTrials.gov

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