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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reverse trigger | Proportion of patients who developed reverse trigger | 60 days |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Mechanically ventilated patients with acute respiratory distress syndrome.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Ibarra-Estrada, MD | Contact | +523317593502 | drmiguelibarra@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel Ibarra Estrada, MD | Hospital Civil Fray Antonio Alcalde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil Fray Antonio Alcalde | Recruiting | Guadalajara | 44280 | Mexico |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| 60 days |
| Mortality | Rate of deceased patients in percentage | 60 days |
| 60 days |
| Intensity of breathing efforts | Intensity of respiratory efforts as measured by esophageal manometry | 60 days |
| Association with severity | Association of RT with lung disease severity as measured by pO2:FiO2 ratio | 60 days |
| Response to ventilatory adjustments | Change in RT characteristics after changing ventilatory settings | 60 days |