How side-to-side body positioning affects breathing and lung aeration in ventilated ICU patients

Analysis of Respiratory Drive Activation, Ventilation, and Pulmonary Aeration Resulting From Body Lateralization in Critically Ill Patients Under Mechanical Ventilation

This project will test whether automatic side-to-side positioning (automatic lateralization), with or without added flow bias, improves breathing drive, ventilation, and lung aeration in adult ICU patients on mechanical ventilation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pernambuco (other)
• Locations: 1 site (Recife, Pernamu)
• Trial ID: NCT07323472 on ClinicalTrials.gov

What this trial studies

This is a quasi-experimental, non-randomized physiological intervention performed in a controlled ICU setting on sedated adult patients receiving invasive mechanical ventilation. Participants will undergo Automatic Lateralization Therapy at progressive tilt angles (0°, 15°, 30°) with and without Flow Bias, and positioning will be personalized using Electrical Impedance Tomography (EIT) to optimize lung recruitment. Outcomes include respiratory drive measures (P0.1, estimated Pmus), diaphragm and parasternal activity via surface EMG, ventilatory mechanics, gas exchange, regional aeration by EIT, and confirmation with lung ultrasound. The protocol follows TREND guidance for transparent reporting of non-randomized evaluations.

Who should consider this trial

Good fit: Adults (≥18 years) in the ICU on invasive mechanical ventilation for ≥24 hours who are sedated (RASS −1 to −4), BMI 18–35 kg/m², hemodynamically and respiratory stable, and demonstrating neural respiratory drive are the intended participants.

Not a fit: Patients who are hemodynamically unstable, have contraindications to lateral positioning, lack measurable respiratory drive, require immediate aerosol or heated humidification, or are expected to be extubated or have rapidly changing support needs may not receive benefit.

Why it matters

Potential benefit: If successful, the approach could reduce respiratory effort, improve ventilation distribution and lung aeration, and potentially lower pulmonary complications and aid recovery in mechanically ventilated ICU patients.

How similar studies have performed: Prior work on lateral positioning and continuous rotation has shown improvements in regional ventilation and aeration, but effects on neural respiratory drive are not well established and combining lateralization with Flow Bias is relatively novel.

Eligibility criteria

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 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 \<92% or ≥20% from baseline, need for FiO₂ increase \>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.

Where this trial is running

Recife, Pernamu

• Hospital Geral Otávio de Freitas - Secretaria de Saúde de Pernambuco — Recife, Pernamu, Brazil (RECRUITING)

Study contacts

• Principal investigator: Emanuel Fernandes Ferreira da Silva Júnior, MSc — Federal University of Pernambuco (UFPE) - Health-Applied Biology Graduate Program, Federal University of Pernambuco, Recife, Brazil
• Study coordinator: Shirley Lima Campos, PhD

Conditions: Intensive Care Units, Automatic lateralization therapy, Critical illness, Continuous lateral rotation, Electrical impedance tomography, Surface electromyography, Respiratory muscles