Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

NCT ID: NCT06148467

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2026-02-01

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.

Detailed Description

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.

Conditions

Reverse Trigger; Acute Respiratory Distress Syndrome; Mechanical Ventilation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Civil de Guadalajara

OTHER

Sponsor Role: lead

Responsible Party

Miguel Á Ibarra-Estrada

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel Ibarra Estrada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Civil Fray Antonio Alcalde

Locations

Hospital Civil Fray Antonio Alcalde

Guadalajara, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Miguel Ibarra-Estrada, MD

Role: CONTACT

drmiguelibarra@hotmail.com

+523317593502

Facility Contacts

Miguel Ibarra-Estrada, MD

Role: primary

drmiguelibarra@hotmail.com

3317593502

Guadalupe Aguirre-Avalos, MD

Role: backup

guadalupe.aavalos@academicos.udg.mx

Other Identifiers

260/22

Identifier Type: -

Identifier Source: org_study_id