Body Lateralization and Its Effects on Respiratory Drive, Ventilation, and Pulmonary Aeration in Critically Ill Patients

NCT07323472 | Recruiting DMC

• 2 other identifiers: LATLUNG92079725.0.0000.5208
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intensive Care Units (ICUs)

Keywords

Automatic lateralization therapy; Critical illness; Continuous lateral rotation; Electrical impedance tomography; Surface electromyography; Respiratory muscles

Outcome Measures

Primary Outcomes (5)

• Respiratory drive parameters: Surface electromyography (sEMG)

  The respiratory drive parameter will be assessed using surface electromyographic (sEMG) activity of the respiratory muscles, including the diaphragm and parasternal intercostals, expressed in microvolts (µV) (Silva Junior et al., 2023). Data are given in: • µV: Microvolts Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Respiratory drive parameter: P0.1 (airway occlusion pressure during the first 100 ms of the inspiratory effort)

  The respiratory drive parameter will be assessed by P0.1(airway occlusion pressure during the first 100ms of the inspiratory effort,cmH₂O).P0.1 is the drop in airway pressure within 100 ms after the onset of inspiration and is considered a reliable, fast, and feasible bedside marker.The following values are considered: Normal: 1.5-3.5 cmH₂O; Low: \<1.0 cmH₂O(hypostimulated); High:\>4.0 cmH₂O (hyperstimulated)(CHEN et al.,2023). Data are given in: cmH₂O: centimeters of water Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes Bilateral.

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes(6 hour 10 minutes)

• Respiratory drive parameters: Pmus (estimated inspiratory muscle pressure)

  The respiratory drive will be assessed using Pmus (estimated inspiratory muscle pressure). Pmus is derived from the airway pressure drop during a brief inspiratory occlusion and reflects inspiratory effort. Reference ranges: Pmus \< 5 cmH₂O indicates over-assistance/low drive; Pmus ≤ 10 cmH₂O represents the diaphragmatic protection zone; Pmus \> 13-15 cmH₂O indicates excessive effort (Dianti, Bertoni ;Goligher, 2020). Data are given in: •cmH₂O: centimeters of water Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Pulmonary ventilation: Ventilation Impedance Change (ΔZ)

  ΔZ will be quantified using electrical impedance tomography (EIT). ΔZ represents the sum of impedance changes of all pixels within a predefined region of interest (ROI), corresponding to regional tidal ventilation. ROIs will include right anterior, left anterior, right posterior, and left posterior lung regions, and will also be categorized as dependent or non-dependent lung areas. Data will be expressed in arbitrary units (a.u.). Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Pulmonary aeration: End-Expiratory Lung Impedance Change (ΔEELZ)

  ΔEELZ will be assessed using electrical impedance tomography (EIT). ΔEELZ corresponds to the aggregate end-expiratory impedance (sum of pixel values) within each ROI, representing changes in end-expiratory lung volume. ROIs will include right anterior, left anterior, right posterior, and left posterior lung regions, grouped as dependent or non-dependent areas. Data will be expressed in arbitrary units (a.u.). Measurements will be performed during the first and last 5 minutes of each body angulation. Unilateral: 140 minutes \| Bilateral: 370 minutes. Following the sequence: Semi-seated 30°/20 minutes, Supine 0°/5 minutes, 15°/20 minutes, 30°/20 minutes, 15°/20 minutes, Supine 0°/5 minutes, and Semi-seated 30°/20 minutes, totaling 70 minutes per sequence plus 60 minutes of washout between sequences. This results in 140 minutes for patients undergoing Unilateral Lateralization Therapy and 370 minutes for patients undergoing Bilateral Lateralization Therapy.

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

Secondary Outcomes (18)

• Mechanical response associated with respiratory drive: Diaphragmatic excursion

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Mechanical response related to respiratory effort and lung stress: Dynamic transpulmonary driving pressure

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Driving Pressure (cmH₂O)

  Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)

• Respiratory System Compliance (mL/cmH₂O)

  Unilateral: 140 minutes (2 hours and 20 minutes) Bilateral: 370 minutes (6 hours and 10 minutes)

• Airway Resistance (cmH₂O/L/s)

  Unilateral: 140 minutes (2 hours and 20 minutes) Bilateral: 370 minutes (6 hours and 10 minutes)

Other Outcomes (1)

• Clinical Severity - SAPS 3 (Baseline)

  Baseline (pre-intervention).

Study Arms (2)

Supine Positioning

ACTIVE COMPARATOR

Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied.

Other: Supine Positioning

Automatic lateralization therapy

ACTIVE COMPARATOR

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.

Other: Automatic Lateralization Therapy

Interventions

Automatic Lateralization Therapy OTHER

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.

Also known as: Continuous lateral positioning, Automatic patient positioning, Continuous lateral rotation therapy, Lateral rotation therapy, Continuous rotational therapy, Kinetic bed therapy, Lateral change Positioning, Automated lateral rotation, Rotating bed, Automatic lateral therapy, Kinetic Therapy, Automated Lateral Rotation Therapy

Automatic lateralization therapy

Supine Positioning OTHER

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.

Also known as: Supine, Semi-recumbent position, Recumbent position, Dorsal decubitus, Conventional supine care

Supine Positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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).

You may not qualify 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);
• 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;

Sponsors & Collaborators

• University of Pernambuco: lead
• Universidade Federal de Pernambuco: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital Geral Otávio de Freitas - Secretaria de Saúde de Pernambuco

Recife, Pernamu, 50670-901, Brazil

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Critical Illness

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emanuel Fernandes Ferreira da Silva Júnior, MSc

  Federal University of Pernambuco (UFPE) - Health-Applied Biology Graduate Program, Federal University of Pernambuco, Recife, Brazil

  PRINCIPAL INVESTIGATOR

• Shirley Lima Campos Lima Campos, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Central Study Contacts

Shirley Lima Campos, PhD

CONTACT

+5581999413087; shirley.campos@ufpe.br

Emanuel Fernandes Ferreira da Silva Júnior, MSc

CONTACT

+ 55 81 99703-9934; emanuel.silvajunior@ufpe.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Apart from the participants and the researchers responsible for data analysis, no other role is blinded in the study. 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Model Details: Quasi-experimental study with a non-randomized physiological interventional design in a single group of critically ill adult patients under mechanical ventilation. Each participant will undergo all intervention conditions, including different body lateralization angles (0°, 15°, 30°) with Automatic Lateralization Therapy with and without Flow Bias. Repeated measures will include respiratory drive, ventilation, and pulmonary aeration assessed by P0.1, estimated Pmus, sEMG, EIT, and ultrasound, allowing each participant to serve as their own control.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Through study completion
• Access Criteria: Individual participant data (IPD) access will be granted by the PI after request review for approval via email. It will be shared with researchers and general public of interest on the subject for descriptive analyses related to our sample. A committee of researchers will be in charge of discussing the request before approving the access.

Locations

BR (1)