Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06148467

Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Civil Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location status: Recruiting

Location contact

Arnulfo López-Pulgarín, MD

SUB_INVESTIGATOR

David Hernández-Lugo, MD

SUB_INVESTIGATOR

Guadalupe Aguirre-Avalos, MD

CONTACT

[email protected]

Guadalupe Aguirre-Avalos, PhD

SUB_INVESTIGATOR

Miguel Ibarra-Estrada, MD

CONTACT

[email protected]

3317593502

Miguel Ibarra-Estrada, MD

PRINCIPAL_INVESTIGATOR

Quetzalcóatl Chávez-Peña, MD

SUB_INVESTIGATOR

About this study

Measurements:

An esophageal catheter for manometry will be placed as usual practice with confirmation of adequate position with the Baydur's occlusion test before recordings. An independent flow sensor and pressure transducer will be placed and connected to a laptop computer to obtain real-time monitoring along with continuous recordings, which then will be off-line analyzed by two experts, for confirmation of RT and characterization.

Data collection:

Main cause of the acute respiratory failure and days on mechanical ventilation until enrollment will be collected as well as demographic characteristics, including APACHE II, SOFA and the previous requirement of prone positioning therapy.

At identification of the RT, drugs for sedation and analgesia, time from initiation of mechanical ventilation to RT identification and blood gas analysis will be recorded. Ventilatory settings will also be collected, including the control variable of the ventilatory mode (volume or pressure), respiratory rate, received tidal volume in ml/kg of predicted body weight, maximum inspiratory flow, ratio of partial arterial oxygen pressure (pO2) to fraction of inspired oxygen (FiO2), driving pressure and (positive end-expiratory pressure (PEEP). Data about esophageal pressure related to RT will also be recorded, including the magnitude of pressure swing, phase angle, coefficient of variation, RT phenotype, entrainment ratio and the presence of breath stacking.

Patient-centered outcomes including length of mechanical ventilation, intensive care and hospital length of stay, and mortality will be followed-up until 60 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Incidence of reverse trigger

    Time frame: 60 days

    Proportion of patients who developed reverse trigger

Secondary outcomes

  1. Days of mechanical ventilation

    Time frame: 60 days

    Days of mechanical ventilation

  2. ICU length of stay

    Time frame: 60 days

    Days from ICU admission to discharge to wards

  3. Mortality

    Time frame: 60 days

    Rate of deceased patients in percentage

Other outcomes

  1. Duration of RT

    Time frame: 60 days

    Total time of presence of RT

  2. Phenotypes of RT

    Time frame: 60 days

    Rate of the different phenotypes according to cycle initiation and termination of patient's respiratory effort

  3. Intensity of breathing efforts

    Time frame: 60 days

    Intensity of respiratory efforts as measured by esophageal manometry

  4. Association with severity

    Time frame: 60 days

    Association of RT with lung disease severity as measured by pO2:FiO2 ratio

  5. Response to ventilatory adjustments

    Time frame: 60 days

    Change in RT characteristics after changing ventilatory settings

Study contacts

Contact information is provided by the study sponsor or research team.

Miguel Ibarra-Estrada, MD

CONTACT

[email protected]

+523317593502

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

Incidence of Reverse Trigger Phenotypes and Response to Ventilatory Adjustments in Patients With ARDS

Acronym: RT-CHASERS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 28, 2023
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.