CClinicalTrials.gg
Not yet recruitingNCT07737483Updated Jul 30, 2026

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

An observational study in Extubation Failure, sponsored by Hospital H+ Queretaro. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Hospital H+ Queretaro · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Extubation Failure

Keywords

  • Cough Peak Flow
  • Mechanical Ventilation
  • Intensive Care Unit
  • Airway Protection
  • Tidal Volume
  • Respiratory Weaning
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mechanically ventilated adult patients

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

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).

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07737483
Lead sponsor
Hospital H+ Queretaro
Responsible party
Jose J Zaragoza, MD MSc (Dr, Hospital H+ Queretaro) — Principal investigator
First posted
Jul 30, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Jul 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion