Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients
NCT ID: NCT07323472
Last Updated: 2026-01-09
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-01
2027-12-30
Brief Summary
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* 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.
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Detailed Description
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Critically ill patients under mechanical ventilation frequently develop respiratory complications due to immobility and altered pulmonary mechanics. Automatic Lateralization Therapy has emerged as a promising physiologic intervention to optimize ventilation and reduce respiratory dysfunction in this population. However, its effects on respiratory drive activation remain poorly understood.
Objective:
To evaluate the effects of body lateralization on respiratory drive activation, ventilation, and pulmonary aeration in mechanically ventilated critically ill patients.
Methods and Design:
This is a quasi-experimental, non-randomized physiological intervention study conducted in a controlled ICU environment, following the TREND 2025 Statement Checklist for transparent reporting of non-randomized evaluations. Automatic Lateralization Therapy will be applied with and without Flow Bias, using progressive body tilt angles (0°, 15°, and 30°). Positioning strategies will be personalized based on Electrical Impedance Tomography (EIT) findings to ensure optimal lung recruitment and safety.
Collected data will include:
Clinical and physiological parameters such as respiratory drive (P0.1, estimated Pmus),
Diaphragm and parasternal muscle activity via surface electromyography (sEMG),
Ventilatory mechanics and gas exchange,
Pulmonary aeration and regional ventilation distribution assessed by EIT,
Additional monitoring by lung ultrasound to confirm aeration patterns.
The investigator performing the physiological data analysis will be blinded to the intervention group to minimize bias. Cardiorespiratory safety (e.g., hemodynamic stability, oxygenation) and adverse events will be monitored throughout all procedures.
Expected Outcomes:
The study aims to provide insights into whether body lateralization through Automatic Lateralization Therapy, modulates respiratory drive and improves ventilation efficiency in critically ill patients. It is hypothesized that combining Automatic Lateralization Therapy, with Flow Bias will enhance pulmonary expansion, respiratory drive activation, and gas exchange efficiency compared to Automatic Lateralization Therapy, alone, while maintaining patient safety.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
The researchers responsible for carrying out the interventions and conducting the study are not blinded to the intervention conditions.
Blinding is applied only to:
* Participants: sedated and, therefore, unaware of the intervention received.
* Researchers responsible for data analysis: blinded to the intervention conditions during the evaluation of physiological and ventilatory parameters.
Study Groups
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Supine Positioning
Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied.
Supine Positioning
During this analysis phase, patients will be positioned on a Multicare bed (LINET) in the dorsal decubitus position with the head of the bed elevated to 30°. Data will be collected on hemodynamic monitoring, respiratory drive, respiratory mechanics, degree of lung involvement, regional distribution of ventilation and aeration, and gas exchange.
Automatic lateralization therapy
Participants will undergo continuous lateral positioning on an automated bed, with automatic angle and time adjustments. The second sequence will be combined with the Flow Bias intervention.
Automatic Lateralization Therapy
During this phase of analysis and intervention related to lateral positioning, patients will be maintained on a Multicare bed (LINET) and subjected to personalized lateral positioning based on the morphofunctional pattern detected by electrical impedance tomography. This positioning will be performed using automatic lateralization therapy, programmed for unilateral or bilateral application, continuously alternating between angles of 0°, 15°, and 30°, maintained for 20 minutes at each position. The procedure will be conducted in two sequences, with the second sequence combined with the Flow Bias intervention. At each angle, data will be collected on hemodynamic monitoring, respiratory drive, respiratory mechanics, regional distribution of ventilation and aeration, and gas exchange.
Interventions
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Automatic Lateralization Therapy
During this phase of analysis and intervention related to lateral positioning, patients will be maintained on a Multicare bed (LINET) and subjected to personalized lateral positioning based on the morphofunctional pattern detected by electrical impedance tomography. This positioning will be performed using automatic lateralization therapy, programmed for unilateral or bilateral application, continuously alternating between angles of 0°, 15°, and 30°, maintained for 20 minutes at each position. The procedure will be conducted in two sequences, with the second sequence combined with the Flow Bias intervention. At each angle, data will be collected on hemodynamic monitoring, respiratory drive, respiratory mechanics, regional distribution of ventilation and aeration, and gas exchange.
Supine Positioning
During this analysis phase, patients will be positioned on a Multicare bed (LINET) in the dorsal decubitus position with the head of the bed elevated to 30°. Data will be collected on hemodynamic monitoring, respiratory drive, respiratory mechanics, degree of lung involvement, regional distribution of ventilation and aeration, and gas exchange.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Universidade Federal de Pernambuco
OTHER
Fundação de Amparo à Ciência e Tecnologia de Pernambuco
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
University of Pernambuco
OTHER
Responsible Party
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Shirley Lima Campos
Principal Researcher
Principal Investigators
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Emanuel Fernandes Ferreira da Silva Júnior, MSc
Role: PRINCIPAL_INVESTIGATOR
Federal University of Pernambuco (UFPE) - Health-Applied Biology Graduate Program, Federal University of Pernambuco, Recife, Brazil
Shirley Lima Campos Lima Campos, PhD
Role: STUDY_DIRECTOR
Universidade Federal de Pernambuco
Locations
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Hospital Geral Otávio de Freitas - Secretaria de Saúde de Pernambuco
Recife, Pernamu, Brazil
Countries
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Central Contacts
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Facility Contacts
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Rômulo de Aquino Coelho Lins Direção do Hospital Geral Otávio de Freitas, MSc
Role: primary
References
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Dianti J, Bertoni M, Goligher EC. Monitoring patient-ventilator interaction by an end-expiratory occlusion maneuver. Intensive Care Med. 2020 Dec;46(12):2338-2341. doi: 10.1007/s00134-020-06167-3. Epub 2020 Jul 4. No abstract available.
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Silva Junior EFFD, Campos SL, Leite WS, Melo PVS, Lins RAC, Araujo MDGR, Guerino MR. Surface electromyography signal processing and evaluation on respiratory muscles of critically ill patients: A systematic review. PLoS One. 2023 Apr 27;18(4):e0284911. doi: 10.1371/journal.pone.0284911. eCollection 2023.
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ROSA, Jéssica dos Santos Pereira et al. Impacts in the Respiratory Mechanics of the Ventilator Hyperinsuflation in the Flow Bias Concept: a Narrative Review. Journal of Health Sciences, v. 21, n. 3, p. 250-254, 2019.
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Study Documents
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Document Type: Study Protocol
The Multicare: Bed for Protocol is used to standardize therapeutic positioning, ensuring precision and safety in evaluating the postural effects on lung aeration and respiratory drive
View DocumentOther Identifiers
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92079725.0.0000.5208
Identifier Type: OTHER
Identifier Source: secondary_id
LATLUNG
Identifier Type: -
Identifier Source: org_study_id
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