Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in … (NCT07323472) | Clinical Trial Compass
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Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients
Brazil30 participantsStarted 2026-01-01
Plain-language summary
The goal of this quasi-experimental study is to investigate how different body positions, performed through Automatic Lateralization Therapy, affect respiratory drive, ventilation, and pulmonary aeration in critically ill adult patients under mechanical ventilation. The main questions this study aims to answer are:
* Does Automatic Lateralization Therapy, modify respiratory drive, as measured by P0.1, estimated Pmus, and sEMG of the diaphragm and parasternal muscles?
* Is there an association between respiratory drive, ventilation, and pulmonary aeration measured by Electrical Impedance Tomography (EIT) in different body positions promoted by Automatic Lateralization Therapy ?
Does combining Automatic Lateralization Therapy, with Flow Bias improve physiological and functional outcomes compared to Automatic Lateralization Therapy, without Flow Bias?
Participants will:
* Be positioned in different lateralization strategies using Automatic Lateralization Therapy, while under mechanical ventilation;
* Have respiratory parameters and ventilation images assessed by EIT and sEMG;
Participate only during their ICU stay, with no need for additional visits after discharge.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of both sexes will be included;
* Aged ≥ 18 years;
* BMI 18-35 kg/m²;
* Under invasive mechanical ventilation via orotracheal tube for ≥ 24 hours and expected to remain on mechanical ventilatory support for at least 48 hours;
* Sedated (Richmond Agitation-Sedation Scale \[RASS\] -1 to -4);
* Well adapted to protective ventilation strategies in VCV or PSV modes;
* Presenting neural respiratory drive evidenced by a drop in Delta Pocc and/or the presence of assisted cycles;
* Hemodynamically stable (mean arterial pressure between 60-120 mmHg, systolic arterial pressure between 90-180 mmHg, diastolic arterial pressure between 60-100 mmHg, and heart rate between 50-150 bpm) with or without vasoactive drugs at the time of data collection (\> 0.1 to 0.3 mcg/kg/min);
* Respiratory stability, no use of accessory muscles and target SpO₂ achieved;
* No indication for nebulization or heated humidification at the time of collection;
* Positive tolerance test for lateral decubitus positioning;
* Chest circumference of 78-87.9 cm (XS), 88-99.9 cm (S), or 100-111.9 cm (M).
Exclusion Criteria:
* Patients presenting medical restrictions to body repositioning, or to the use of EIT or sEMG;
* Those in therapeutic failure;
* Individuals with spinal cord injury, brain injury, or stroke with a history of functional loss and respiratory impairment prior to hospitalization;
* Neurological diseases affecting respiratory myoelectric conduction;
* History of postural de…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.