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AzTrials

Intensive Care Units (ICUs)LATLUNGNCT07323472

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

A study testing Automatic Lateralization Therapy and Supine Positioning in people with Intensive Care Units (ICUs), run by University of Pernambuco at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intensive Care Units (ICUs)
What is being tested?
Automatic Lateralization Therapy and Supine Positioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
1 Jan 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Brazil1 site, 1 recruiting

  • Hospital Geral Otávio de Freitas - Secretaria de Saúde de Pernambuco

    Recife, Pernamu, 50670-901

    Rômulo de Aquino Coelho Lins Direção do Hospital Geral Otávio de Freitas, MSc, +55 81 9 9486498, romulo.aquino@ufpe.br

    Elaine Araújo de Souza, Specialist

    Recruiting

Other trials in Brazil

About this study

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

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 ?
Read more

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.

Read the detailed description

Detailed Description:

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.

Being tested
Automatic Lateralization Therapy, Supine Positioning
Keywords
Automatic lateralization therapy, Critical illness, Continuous lateral rotation, Electrical impedance tomography, Surface electromyography, Respiratory muscles
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Automatic Lateralization TherapyOther

    Also called Continuous lateral positioning, Automatic patient positioning, Continuous lateral rotation therapy, Lateral rotation 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 PositioningOther

    Also called Supine, Semi-recumbent position, Recumbent position, Dorsal decubitus

    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.

Study groups in NCT07323472
Study groupRoleWhat they receive
Supine PositioningActive comparatorParticipants will remain in supine position with 30° head elevation. No lateralization therapy is applied.
Receives: Other: Supine Positioning
Automatic lateralization therapyActive comparatorParticipants 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.
Receives: Other: Automatic Lateralization Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (18)

  1. Mechanical response associated with respiratory drive: Diaphragmatic excursion

    Diaphragmatic excursion will be assessed by ultrasonography using a convex transducer placed along the right mid-clavicular line, using the liver as an acoustic window. The procedure follows established ICU protocols and can be performed without ventilator disconnection. In this study, ventilation will remain connected, and diaphragmatic excursion will be quantified in millimeters (mm) (Santana et al., 2020).

    Data are given in: mm: Millimeters. 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.

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

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

    Dynamic transpulmonary driving pressure (cmH₂O) will assess the mechanical response to respiratory effort and lung stress. It is derived from the same expiratory occlusion maneuver used for Pmus, applying a correction formula to isolate lung distension. This provides a non-invasive measure of dynamic lung stress during ventilation. Recent studies have targeted values between 15 and 20 cmH₂O (Dianti et al., 2022).

    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.

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

  3. Driving Pressure (cmH₂O)

    Driving pressure will be assessed using ventilator-derived parameters during mechanical ventilation to estimate lung stress under different body angulations and lateralization strategies. Driving pressure will be calculated as the difference between plateau pressure (Pplat) and positive end-expiratory pressure (PEEP), according to the formula: Driving Pressure = Pplat - PEEP.

    Data will be expressed 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 Lateralization Therapy.

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

  4. Respiratory System Compliance (mL/cmH₂O)

    Respiratory system compliance will be evaluated using ventilator-derived parameters to assess lung distensibility during different body angulations and lateralization strategies under mechanical ventilation.

    Respiratory system compliance will be calculated as the ratio between tidal volume (VT) and driving pressure, according to the formula:

    Compliance = VT/ (plateau press - PEEP).

    Data will be expressed 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 Lateralization Therapy.

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

  5. Airway Resistance (cmH₂O/L/s)

    Airway resistance will be measured using ventilator-derived parameters to evaluate airflow resistance during mechanical ventilation across different body angulations and lateralization strategies.

    Calculated as the difference between peak inspiratory pressure (Ppeak) and plateau pressure (Pplat) divided by inspiratory flow, according to the formula:

    Airway Resistance = (Ppeak - Pplat) / Inspiratory Flow

    Data will be expressed 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

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

  6. Arterial pH

    Arterial pH measured from arterial blood gas (ABG) analysis at predefined time points: baseline (prior to the first intervention), immediately after completion of Sequence 1, and immediately after completion of Sequence 2.

    Unit: pH units.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2. Unit: pH units.

  7. Partial pressure of oxygen (PaO₂)

    Arterial PaO₂ measured via arterial blood gas at baseline, immediately after Sequence 1, and immediately after Sequence 2. Values obtained from arterial blood samples analyzed by standard blood gas analyzer.

    Unit: mmHg.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  8. Partial pressure of carbon dioxide (PaCO₂)

    Arterial PaCO₂ measured via arterial blood gas at baseline, immediately after Sequence 1, and immediately after Sequence 2.

    Unit: mmHg.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  9. Bicarbonate (HCO₃-)

    Arterial bicarbonate (HCO₃-) concentration obtained from arterial blood gas analysis at baseline, immediately after Sequence 1, and immediately after Sequence 2.

    Unit: mEq/L.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  10. Lactate

    Arterial lactate concentration obtained from arterial blood gas or arterial blood sample at baseline, immediately after Sequence 1, and immediately after Sequence 2.

    Unit: mmol/L.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  11. Base Excess (BE)

    Base excess determined from arterial blood gas analysis at baseline, immediately after Sequence 1, and immediately after Sequence 2.

    Unit: mEq/L.

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  12. PaO₂/FiO₂ ratio

    PaO₂/FiO₂ ratio calculated from arterial PaO₂ and the fraction of inspired oxygen (FiO₂) at baseline, immediately after Sequence 1, and immediately after Sequence 2. FiO₂ will be recorded at the time of each arterial blood gas sampling.

    Ratio (unitless).

    Measured: Baseline; immediately after Sequence 1; immediately after Sequence 2.

  13. Pulmonary Severity - LUS Score (Lung Ultrasound Score)

    Pulmonary severity will be assessed using lung ultrasound (LUS), quantified by the Lung Ultrasound Score (LUS Score). Assessments will occur at three predefined time points: baseline (prior to the first intervention), immediately after the completion of Sequence 1, and immediately after the completion of Sequence 2.

    Pulmonary aeration will be classified according to standardized LUS Score criteria Mongodi, Silvia et al. Anesthesiology, 2021.

    Score 0: Normal lung pattern; up to two isolated B-lines. Score 1: Up to four B-lines, indicating mild loss of aeration. Score 2: More than four B-lines or confluent B-lines, indicating moderate loss of aeration.

    Score 3: Consolidations with coarse artifacts and pleural irregularities, indicating severe loss of aeration.

    Outcome Units: Ordinal scale (0 to 3 per region) and total summed score.

    Measured: Baseline, immediately after Sequence 1, and immediately after Sequence 2.

  14. Hemodynamic Instability Events

    Number of hemodynamic instability episodes defined by sustained Mean Arterial Pressure (MAP) < 60 mmHg or > 120 mmHg, each lasting more than 10 minutes, recorded throughout the intervention period. Unit: Number of events

    Measured: At any time during the intervention and immediately after completion.

  15. Psychomotor Agitation - Richmond Agitation-Sedation Scale (RASS Score)

    Psychomotor agitation or sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS) during each predefined body position and angulation throughout the therapy sequence.

    The RASS score ranges from -5 (unarousable) to +4 (combative), with higher positive scores indicating greater agitation and more negative scores indicating deeper levels of sedation.

    During each body position and angulation within the intervention sequence, assessed at the end of each positioning period, including:

    Semi-seated 30° (20 minutes) Supine 0° (5 minutes) Lateralization 15° (20 minutes) Lateralization 30° (20 minutes) Lateralization 15° (20 minutes) Supine 0° (5 minutes) Semi-seated 30° (20 minutes), for a total of 70 minutes per sequence, with a 60-minute washout period between sequences.

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

  16. Oxygenation and Hypoxemia Events (SpO₂ Monitoring + Hypoxemia Criteria)

    Continuous monitoring of peripheral oxygen saturation (SpO₂) during each therapy session.

    Any episode meeting one or more of the following hypoxemia criteria will be recorded:

    • SpO₂ < 92%, or > 20% decrease from baseline;
    • Need to increase FiO₂ > 50% or > 20% above baseline;
    • Need to increase PEEP;
    • Associated hemodynamic instability (including changes in PAM according to predefined limits).

    All events will be documented throughout the intervention. Unit: Number of events.

    Measured: Continuous monitoring; events recorded at any time during the intervention.

  17. Unplanned Removal of Devices

    Occurrence of unplanned removal of tubes or catheters during therapy (e.g., endotracheal tube, feeding tube, urinary catheter). Unit: Number of events.

    Measured: During the intervention.

  18. Serious Adverse Events

    Occurrence of pneumothorax, cardiopulmonary arrest, or any event requiring emergency interruption or modification of therapy. Unit: Number of events.

    Measured: During the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start1 Jan 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07323472
Sponsor's protocol ID
LATLUNG
Other IDs
92079725.0.0000.5208
Acronym
LATLUNG
Status last verified
Jan 2026
First submitted
14 Nov 2025
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Participant characteristics Medical history Clinical measurements Functional results Images (USG) Adverse events

Publications

  • Salluh JI, Soares M. ICU severity of illness scores: APACHE, SAPS and MPM. Curr Opin Crit Care. 2014 Oct;20(5):557-65. doi: 10.1097/MCC.0000000000000135.

    PubMed 25137401

  • 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.

    PubMed 32623476

  • Chen H, Liang M, He Y, Teboul JL, Sun Q, Xie J, Yang Y, Qiu H, Liu L. Inspiratory effort impacts the accuracy of pulse pressure variations for fluid responsiveness prediction in mechanically ventilated patients with spontaneous breathing activity: a prospective cohort study. Ann Intensive Care. 2023 Aug 17;13(1):72. doi: 10.1186/s13613-023-01167-0.

    PubMed 37592166

  • 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.

    PubMed 37104255

  • Costa LSP, Reinaux CMA, Junior EFFS, Leite WS, Brandao DC, de Andrade AD, Roldan R, Morais CCA, Campos SL. Physiology of body lateralization on regional lung ventilation and lung volumes in healthy subjects: Within-subjects design. PLoS One. 2025 Oct 30;20(10):e0335622. doi: 10.1371/journal.pone.0335622. eCollection 2025.

    PubMed 41166369

  • Zack MB. Pectoriloquy, a retrospective analysis. Chest. 2009 Jan;135(1):8-9. doi: 10.1378/chest.08-2261. No abstract available.

    PubMed 19136401

  • Vedrenne-Cloquet M, Ito Y, Hotz J, Klein MJ, Herrera M, Chang D, Bhalla AK, Newth CJL, Khemani RG. Phenotypes based on respiratory drive and effort to identify the risk factors when P0.1 fails to estimate ∆PES in ventilated children. Crit Care. 2024 Oct 4;28(1):325. doi: 10.1186/s13054-024-05103-x.

    PubMed 39367452

  • Umbrello M, Formenti P, Longhi D, Galimberti A, Piva I, Pezzi A, Mistraletti G, Marini JJ, Iapichino G. Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study. Crit Care. 2015 Apr 13;19(1):161. doi: 10.1186/s13054-015-0894-9.

    PubMed 25886857

  • Suttapanit K, Wongkrasunt S, Savatmongkorngul S, Supatanakij P. Ultrasonographic evaluation of the diaphragm in critically ill patients to predict invasive mechanical ventilation. J Intensive Care. 2023 Sep 19;11(1):40. doi: 10.1186/s40560-023-00690-3.

    PubMed 37726832

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Questions about this trial

What is this clinical trial studying?

A study testing Automatic Lateralization Therapy and Supine Positioning in people with Intensive Care Units (ICUs), run by University of Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shirley Lima Campos, PhD (+5581999413087, shirley.campos@ufpe.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory drive parameters: Surface electromyography (sEMG) (time frame: Unilateral: 140 minutes (2 hour 20 minutes) | Bilateral: 370 minutes (6 hour 10 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07323472, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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