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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: shirley.campos@ufpe.br
• Phone: +5581999413087

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Monitoring diaphragm electrical activity and breathing effort during ventilator weaning

  We will see if surface diaphragm EMG, esophageal pressure, and oxygen use measured during a spontaneous breathing trial can predict who will fail to wean from the ventilator in the ICU.

  Recruiting Leiden University Medical Center · Leiden · NCT07109570

• ICU rehabilitation for adults on invasive mechanical ventilation

  This project will look at rehabilitation approaches used in ICUs worldwide to see if they relate to outcomes for adults who have been on invasive mechanical ventilation for at least 48 hours.

  Recruiting Universita degli Studi di Genova · Genova, Italy · NCT07093125

• Evaluating Heart Function During Breathing Trials in ICU Patients

  This study tests which type of breathing trial is easiest on the heart for ICU patients who are trying to breathe on their own without help from machines.

  Recruiting Centre Hospitalier Régional d'Orléans · Orléans · NCT06923267

• Personalized PEEP and Prone Positioning in Severe ARDS

  This trial tests whether tailoring PEEP levels and using prone positioning with or without muscle relaxation can improve outcomes for adults with severe ARDS in the ICU.

  Recruiting at 29 sites Assistance Publique - Hôpitaux de Paris · Aix-en-Provence and 28 other locations · NCT06849570

• Ventilation During Transport of Mechanically Ventilated Patients After Non-Cardiac Surgery

  This observational study looks at how patients who stay intubated after non-cardiac surgery are ventilated during the move from the operating room to the ICU.

  Recruiting Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Alessandria, Italy · NCT07646249

• Preventive Narrative Exposure for PTSD After Cardiac Surgery in the ICU

  In adults having cardiopulmonary bypass heart surgery, this trial tests whether an ICU-based narrative exposure intervention helps prevent posttraumatic stress symptoms compared with standard care.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07632131

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.