NCT06148467

Brief Summary

The goal of this prospective observational study is to describe the incidence of reverse trigger (RT) in mechanically ventilated patients with diagnosis of acute respiratory distress syndrome (ARDS). The main questions it aims to answer are:

  • Real incidence of RT based on continuous monitoring
  • The response to mechanical ventilatiory adjustments Participants will be included as soon as neuromuscular blockers (NMB)/sedation is stopped or in case of spontaneous respiratory efforts detection, whatever happens first. Continuous monitoring will be performed by esophageal manometry until switch to a pressure support (spontaneous) mode, restart of deep sedation/neuromuscular blockers by medical indication, or death. In order to allow detection of possible RT in patients with ongoing sedation/NMB, mechanical ventilator waveforms will be screened every 1-2 hours by investigators and critical care physicians with at least 1 year of specific training in detection of dyssynchronies.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

November 19, 2023

Last Update Submit

March 15, 2025

Conditions

Keywords

Reverse triggerAcute Respiratory Distress SyndromeDyssynchonyMechanical Ventilation

Outcome Measures

Primary Outcomes (1)

  • Incidence of reverse trigger

    Proportion of patients who developed reverse trigger

    60 days

Secondary Outcomes (3)

  • Days of mechanical ventilation

    60 days

  • ICU length of stay

    60 days

  • Mortality

    60 days

Other Outcomes (5)

  • Duration of RT

    60 days

  • Phenotypes of RT

    60 days

  • Intensity of breathing efforts

    60 days

  • +2 more other outcomes

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mechanically ventilated patients with acute respiratory distress syndrome.

You may qualify if:

  • Diagnosis of ARDS according to the Berlin criteria and added New Global Definition 2023
  • Mechanical ventilation

You may not qualify if:

  • \<18 years
  • Tracheostomy status
  • Pneumothorax
  • Tube thoracostomy with air leaks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Miguel Ibarra Estrada, MD

    Hospital Civil Fray Antonio Alcalde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Ibarra-Estrada, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 28, 2023

Study Start

November 17, 2023

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations