Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

Acute Respiratory Distress Syndrome Clinical Trial

— RT-CHASERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148467
• Other study ID #: 260/22
• Status: Recruiting
• Start date: November 17, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: December 2023
• Source: Hospital Civil de Guadalajara
• Contact: Miguel Ibarra-Estrada, MD
• Phone: +523317593502
• Email: drmiguelibarra[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Mechanical Ventilation
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of RT	Total time of presence of RT	60 days
Other	Phenotypes of RT	Rate of the different phenotypes according to cycle initiation and termination of patient's respiratory effort	60 days
Other	Intensity of breathing efforts	Intensity of respiratory efforts as measured by esophageal manometry	60 days
Other	Association with severity	Association of RT with lung disease severity as measured by pO2:FiO2 ratio	60 days
Other	Response to ventilatory adjustments	Change in RT characteristics after changing ventilatory settings	60 days
Primary	Incidence of reverse trigger	Proportion of patients who developed reverse trigger	60 days
Secondary	Days of mechanical ventilation	Days of mechanical ventilation	60 days
Secondary	ICU length of stay	Days from ICU admission to discharge to wards	60 days
Secondary	Mortality	Rate of deceased patients in percentage	60 days