Extubation FailureNCT07737483
Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes
An observational study of Extubation Failure, run by Hospital H+ Queretaro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure
- What is being tested?
- Observational measurement of Cough Peak Flow and Tidal Volume
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Adult patients (≥18 years) admitted to the ICU who received invasive mechanical ventilation for >24 hours and successfully completed a Spontaneous Breathing Trial (SBT).
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Extubation Failure
- Being tested
- Observational measurement of Cough Peak Flow and Tidal Volume
- Keywords
- Cough Peak Flow, Mechanical Ventilation, Intensive Care Unit, Airway Protection, Tidal Volume, Respiratory Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated adult patients | Not described Receives: Diagnostic Test: Observational measurement of Cough Peak Flow and Tidal Volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation failure
Defined as reintubation or the need for rescue Non-Invasive Ventilation (NIV) within 72 hours post-extubation
Measured: 72 hours following the removal of the endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737483
- Sponsor's protocol ID
- CEI2026-07/06/V1
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Effort-Based Cough Peak Flow Algorithm to Predict Extubation Outcomes in the ICU: A Prospective Blinded Cohort Study
- ClinicalTrials.gov ID
- NCT07737483
- Acronym / sponsor ID
- CEI2026-07/06/V1
- Conditions
- Extubation Failure
- Keywords
- Cough Peak Flow, Mechanical Ventilation, Intensive Care Unit, Airway Protection, Tidal Volume, Respiratory Weaning
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated adult patients | – | Diagnostic Test: Observational measurement of Cough Peak Flow and Tidal Volume |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) admitted to the ICU who received invasive mechanical ventilation for >24 hours and successfully completed a Spontaneous Breathing Trial (SBT).
Key exclusion criteria (4 listed)
- Prior indication for tracheostomy (e.g., severe maxillofacial trauma, upper airway obstruction).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational measurement of Cough Peak Flow and Tidal VolumePatients undergo standardized CPF and pre-cough tidal volume (VT) measurements prior to extubation. Measurements are stratified by cooperation level (Voluntary vs. Reflex). | Diagnostic test | Mechanically ventilated adult patients |
Primary outcome
Extubation failure
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Failure, run by Hospital H+ Queretaro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation failure (time frame: 72 hours following the removal of the endotracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.