An observational study in Reverse Trigger, Acute Respiratory Distress Syndrome and Mechanical Ventilation, sponsored by Hospital Civil de Guadalajara. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Hospital Civil de Guadalajara · Observational
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:
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 130 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Hospital Civil de Guadalajara is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Mechanically ventilated patients with acute respiratory distress syndrome.
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Exclusion Criteria:
Incidence of reverse trigger
Proportion of patients who developed reverse trigger
Time frame: 60 days
Days of mechanical ventilation
Days of mechanical ventilation
Time frame: 60 days
ICU length of stay
Days from ICU admission to discharge to wards
Time frame: 60 days
Mortality
Rate of deceased patients in percentage
Time frame: 60 days
Duration of RT
Total time of presence of RT
Time frame: 60 days
Phenotypes of RT
Rate of the different phenotypes according to cycle initiation and termination of patient's respiratory effort
Time frame: 60 days
Intensity of breathing efforts
Intensity of respiratory efforts as measured by esophageal manometry
Time frame: 60 days
Association with severity
Association of RT with lung disease severity as measured by pO2:FiO2 ratio
Time frame: 60 days
Response to ventilatory adjustments
Change in RT characteristics after changing ventilatory settings
Time frame: 60 days
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Dec 2027, 49 months after the start.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 49 months is above that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
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Hospital Civil de Guadalajara