RT-CHASERS: Reverse Trigger Phenotypification and Response to Ventilatory Adjustments

• Sponsor: Hospital Civil de Guadalajara (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06148467
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Anticipated Duration (Months): 26.5
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reverse Trigger; Acute Respiratory Distress Syndrome; Mechanical Ventilation

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 Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Incidence of Reverse Trigger Phenotypes and Response to Ventilatory Adjustments in Patients With ARDS
• Actual Study Start Date: Nov 17, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Feb 1, 2026

Outcome Measures

Primary Outcome Measures

1. Incidence of reverse trigger [60 days]

   Proportion of patients who developed reverse trigger

Secondary Outcome Measures

1. Days of mechanical ventilation [60 days]

   Days of mechanical ventilation

2. ICU length of stay [60 days]

   Days from ICU admission to discharge to wards

3. Mortality [60 days]

   Rate of deceased patients in percentage

Other Outcome Measures

1. Duration of RT [60 days]

   Total time of presence of RT

2. Phenotypes of RT [60 days]

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

3. Intensity of breathing efforts [60 days]

   Intensity of respiratory efforts as measured by esophageal manometry

4. Association with severity [60 days]

   Association of RT with lung disease severity

5. Response to ventilatory adjustments [60 days]

   Change in RT characteristics after changing ventilatory settings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Civil Fray Antonio Alcalde	Guadalajara		Mexico	44280

Sponsors and Collaborators

• Hospital Civil de Guadalajara

Investigators

• Principal Investigator: Miguel Ibarra Estrada, MD, Hospital Civil Fray Antonio Alcalde

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miguel Á Ibarra-Estrada, MD, Hospital Civil de Guadalajara
• ClinicalTrials.gov Identifier: NCT06148467
• Other Study ID Numbers: 260/22
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Miguel Á Ibarra-Estrada, MD, Hospital Civil de Guadalajara: Reverse trigger; Acute Respiratory Distress Syndrome; Dyssynchony; Mechanical Ventilation
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Nov 28, 2023