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New treatment option for Intensive Care Units (ICUs)
Official title Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients
ClinicalTrials.gov ID: NCT07323472
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Sedated (Richmond Agitation-Sedation Scale [RASS] -1 to -4);
You likely can't join if
- 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 deformities, diaphragmatic abnormalities, or colostomy bag;
- Unstable fracture (lower or upper limbs in proximal regions or thorax);
See the full eligibility 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...
- 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).
- 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 deformities, diaphragmatic abnormalities, or colostomy bag;
- Unstable fracture (lower or upper limbs in proximal regions or thorax);
- Pleural effusion requiring drainage;
- Presence of drains in the thoracic and/or abdominal regions;
- Unstable intracranial pressure;
- Pregnant patients;
- Immediate postoperative period of orthopedic surgeries;
- Use of mucolytics;
- Open ventriculostomy for drainage;
- Uncontrolled agitation;
- Pacemaker or implantable cardioverter-defibrillator;
- Pneumothorax;
- Use of neuromuscular blockers;
- Active tuberculosis;
- Traction devices;
- Active bleeding;
- Suspected or confirmed pulmonary embolism without prior treatment within 24 hours;
- Presence of a large mass in the right and/or left hemithorax;
- History of cardiopulmonary arrest within the past 24 hours under neuroprotection;
- In the total weaning phase from IMV and/or tracheostomy and/or enteral feeding tube and/or scheduled CT scan within the next 6 hours;
- Intolerance to the TLA test (SpO₂ drop \ 50% or ≥20% from baseline, need for PEEP increase, or hemodynamic instability within the first 5 minutes of lateralization testing);
- Those who refuse to provide consent, as determined by the legal representative.
The study team makes the final eligibility decision.
Where it's taking place
- Recife, Pernamu, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Recife, Pernamu, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.