Reverse Trigger Phenotypification and Response to Ventilatory Adjustments (RT-CHASERS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation; Reverse Trigger

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.

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Miguel Ibarra-Estrada, MD; Phone Number: +523317593502; Email: drmiguelibarra@hotmail.com

Study Locations

• Mexico
  • Guadalajara, Mexico, 44280
    • Recruiting
    • Hospital Civil Fray Antonio Alcalde
    • Contact: Miguel Ibarra-Estrada, MD; Phone Number: 3317593502; Email: drmiguelibarra@hotmail.com
    • Contact: Guadalupe Aguirre-Avalos, MD; Email: guadalupe.aavalos@academicos.udg.mx
    • Sub-Investigator: Quetzalcóatl Chávez-Peña, MD
    • Sub-Investigator: Arnulfo López-Pulgarín, MD
    • Sub-Investigator: Guadalupe Aguirre-Avalos, PhD
    • Principal Investigator: Miguel Ibarra-Estrada, MD
    • Sub-Investigator: David Hernández-Lugo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Mechanically ventilated patients with acute respiratory distress syndrome.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of reverse trigger	Proportion of patients who developed reverse trigger	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of mechanical ventilation	Days of mechanical ventilation	60 days
ICU length of stay	Days from ICU admission to discharge to wards	60 days
Mortality	Rate of deceased patients in percentage	60 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of RT	Total time of presence of RT	60 days
Phenotypes of RT	Rate of the different phenotypes according to cycle initiation and termination of patient's respiratory effort	60 days
Intensity of breathing efforts	Intensity of respiratory efforts as measured by esophageal manometry	60 days
Response to ventilatory adjustments	Change in RT characteristics after changing ventilatory settings	60 days
Association with severity	Association of RT with lung disease severity as measured by pO2:FiO2 ratio	60 days

Collaborators and Investigators

• Sponsor: Hospital Civil de Guadalajara
• Investigators: Principal Investigator: Miguel Ibarra Estrada, MD, Hospital Civil Fray Antonio Alcalde

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Acute Respiratory Distress Syndrome; Reverse trigger; Dyssynchony
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 260/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No