Intensive Care UnitsNCT07087600

Immediate Effects of Automatic Lateralization in Critically Ill Patients

A study testing Automatic lateralization therapy and Supine Positioning in people with Intensive Care Units, run by University of Pernambuco at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intensive Care Units
What is being tested?: Automatic lateralization therapy and Supine Positioning
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteBrazil
Study dates: 14 Aug 2025to 30 Oct 2025
Phase: Interventional
Are there results?: None posted in the registry

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

Volunteers aged 18 or over;
Of both sexes;
Breathing through an orotracheal tube;
With respiratory and hemodynamic stability.

Who cannot join

Patients with contraindications to change of position;
Acute spinal cord injury;
Unstable fractures and signs of intracranial hypertension;
Pregnant women;
Immediate postoperative period of thoracic, orthopedic and abdominal surgeries;
Use of drains;

Show all 9Show fewer

Grade III obesity (BMI > 40 kg/m2);
Suspected pulmonary thromboembolism;
Agitation and active bleeding.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital Geral Otávio de Freitas
Recife, Pernambuco, 50920-460

Other trials in Brazil

About this study

Official title: Immediate Effects on Ventilatory Morphofunctional Pattern and Cardiorespiratory Safety During Automatic Body Lateralization Therapy in Critically Ill Patients: A Quasi-Experimental Study

New devices have been used in intensive care to optimize respiratory function in critically ill patients, such as automatic lateralization therapy. However, the times and angles used vary widely, and there is no clear evidence of cardiovascular safety and immediate effects, which represents a gap in the literature. This quasi-experimental study aims to evaluate the imediact efficacy and cardiorespiratory safety of automatic lateralization therapy in critically ill patients under invasive mechanical ventilation. The primary outcomes include changes in ventilation distribution and end-expiratory impedance variation. Secondary outcomes include respiratory mechanics, vital signs, and adverse events.

Read the detailed description

Introduction: Electrical impedance tomography (EIT) enables real-time imaging of lung ventilation, guiding interventions such as automatic lateralization therapy. Despite its potential, evidence about immediate effects and safety is limited.

Objective: To evaluate the imediact cardiorespiratory efficacy and safety of automatic lateralization therapy in critically ill patients.

Method: Quasi-experimental, non-randomized, two-arm study. Participants aged ≥18 years, intubated and clinically stable, will undergo both interventions.

Interventions:

Arm 1: Supine position with head elevated at 30°.
Arm 2: Automatic lateralization therapy using programmable bed angles (0°, 15°, and 30°), alternating sides.

Outcomes: Ventilation distribution, impedance variation (ΔZ, ΔEELZ), respiratory mechanics, adverse events, and vital signs will be measured.

Ethical approval has been granted (CAAE 70188523.0.0000.5200). Informed consent will be obtained from legal guardians.

Conditions: Intensive Care Units
Being tested: Automatic lateralization therapy, Supine Positioning
Keywords: Automatic lateralization therapy, Critical illness, Continuous lateral rotation, Electrical impedance tomography
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, kinetic therapy, automated lateral rotation therapy
Program the bed to vary angle and time continuously during the intervention
Supine PositioningOther
Also called Supine, Semi-recumbent position, Recumbent position, Dorsal decubitus
In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°

Study groups in NCT07087600
Study group	Role	What they receive
Automatic lateralization therapy	Active comparator	Participants will undergo automatic lateral positioning using a motorized bed programmed to alternate angles of 0°, 15°, and 30°, switching sides continuously. Receives: Other: Automatic lateralization therapy
Supine position	Active comparator	Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied. Receives: Other: Supine Positioning

What is being measured

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

Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ)
Represents the change in regional pulmonary aeration between the pre- and post-intervention moments.
Measured: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Electrical impedance tomography (EIT): Ventilation Distribution Variation (ΔZ)
Represents the change in ventilation distribution before and after the intervention.
Measured: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.

Secondary outcomes (3)

Adverse events
Monitoring of serious and non-serious adverse events associated with the intervention through an adapted adverse event form
Measured: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Respiratory Mechanics
Data provided through the mechanical ventilator and from inspiratory and expiratory pause maneuvers
Measured: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Vital signs
Viewed on the multiparameter monitor
Measured: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.

Timeline

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

14 Aug 202530 Oct 2025

First posted28 Jul 2025
Study start14 Aug 2025
Primary completion30 Sep 2025
Study completion30 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Parallel groups
Model description: This study is a quasi-experimental, before-and-after study, and contains a single group, in which the group itself is the control. There will be a comparison before, during and after the intervention.
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07087600
Sponsor's protocol ID: 70188523.0.0000.5200
Status last verified: Jul 2025
First submitted: 16 Aug 2024
Last updated: 25 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Upon reasonable request, anonymized data will be made available for scientific use, as: * Participant characteristics (age, gender) * Clinical measurements (blood pressure, heart rate) * Medical history * Clinical laboratory results * Adverse events (hemodynamic and respiratory instability, interruptions) * Details of treatment received

Publications

American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.
PubMed 20507660
Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7.
PubMed 8324411
Doering LV. The effect of positioning on hemodynamics and gas exchange in the critically ill: a review. Am J Crit Care. 1993 May;2(3):208-16.
PubMed 8364672
Doerschug KC, Schmidt GA. Intensive care ultrasound: III. Lung and pleural ultrasound for the intensivist. Ann Am Thorac Soc. 2013 Dec;10(6):708-12. doi: 10.1513/AnnalsATS.201308-288OT. No abstract available.
PubMed 24364779
Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161
Hassan AA, Evrensel CA, Krumpe PE. Clearance of viscoelastic mucus simulant with airflow in a rectangular channel, an experimental study. Technol Health Care. 2006;14(1):1-11.
PubMed 16556959
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
PubMed 11018445
Kang SY, DiStefano MJ, Yehia F, Koszalka MV, Padula WV. Critical Care Beds With Continuous Lateral Rotation Therapy to Prevent Ventilator-Associated Pneumonia and Hospital-Acquired Pressure Injury: A Cost-effectiveness Analysis. J Patient Saf. 2021 Mar 1;17(2):149-155. doi: 10.1097/PTS.0000000000000582.
PubMed 30896557
Molina FJ, Rivera PT, Cardona A, Restrepo DC, Monroy O, Rodas D, Barrientos JG. Adverse events in critical care: Search and active detection through the Trigger Tool. World J Crit Care Med. 2018 Feb 4;7(1):9-15. doi: 10.5492/wjccm.v7.i1.9. eCollection 2018 Feb 4.
PubMed 29430403
Politi S, Aloisi A Jr, Bartoli V, Guglietta A, Magnifica F. Infrared Thermography Images Acquisition for a Technical Perspective in Screening and Diagnostic Processes: Protocol Standardized Acquisition. Cureus. 2021 Nov 27;13(11):e19931. doi: 10.7759/cureus.19931. eCollection 2021 Nov.
PubMed 34976527
Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9.
PubMed 35150355
Staudinger T, Bojic A, Holzinger U, Meyer B, Rohwer M, Mallner F, Schellongowski P, Robak O, Laczika K, Frass M, Locker GJ. Continuous lateral rotation therapy to prevent ventilator-associated pneumonia. Crit Care Med. 2010 Feb;38(2):486-90. doi: 10.1097/CCM.0b013e3181bc8218.
PubMed 19789440
Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.
PubMed 8324412
Volpe MS, Guimaraes FS, Morais CC. Airway Clearance Techniques for Mechanically Ventilated Patients: Insights for Optimization. Respir Care. 2020 Aug;65(8):1174-1188. doi: 10.4187/respcare.07904.
PubMed 32712584
Wanless S, Aldridge M. Continuous lateral rotation therapy - a review. Nurs Crit Care. 2012 Jan-Feb;17(1):28-35. doi: 10.1111/j.1478-5153.2011.00458.x. Epub 2011 Jul 20.
PubMed 22229679

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Intensive Care Units trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate Effects on Ventilatory Morphofunctional Pattern and Cardiorespiratory Safety During Automatic Body Lateralization Therapy in Critically Ill Patients: A Quasi-Experimental Study
ClinicalTrials.gov ID: NCT07087600
Acronym / sponsor ID: 70188523.0.0000.5200
Conditions: Intensive Care Units
Keywords: Automatic lateralization therapy, Critical illness, Continuous lateral rotation, Electrical impedance tomography
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of PernambucoUniversity, hospital or other
Collaborators: Universidade Federal de Pernambuco, Coordination for the Improvement of Higher Education Personnel, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Ciência e Tecnologia de Pernambuco
Study start: 14 Aug 2025 (actual)
Primary completion: 30 Sep 2025 (actual)
Study completion: 30 Oct 2025 (actual)
First posted: 28 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective: To evaluate the imediact cardiorespiratory efficacy and safety of automatic lateralization therapy in critically ill patients.

Method: Quasi-experimental, non-randomized, two-arm study. Participants aged ≥18 years, intubated and clinically stable, will undergo both interventions.

Interventions:

Arm 1: Supine position with head elevated at 30°.
Arm 2: Automatic lateralization therapy using programmable bed angles (0°, 15°, and 30°), alternating sides.

Outcomes: Ventilation distribution, impedance variation (ΔZ, ΔEELZ), respiratory mechanics, adverse events, and vital signs will be measured.

Ethical approval has been granted (CAAE 70188523.0.0000.5200). Informed consent will be obtained from legal guardians.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This study is a quasi-experimental, before-and-after study, and contains a single group, in which the group itself is the control. There will be a comparison before, during and after the intervention.

Arm	Type	Receives
Automatic lateralization therapy	Active comparator	Other: Automatic lateralization therapyParticipants will undergo automatic lateral positioning using a motorized bed programmed to alternate angles of 0°, 15°, and 30°, switching sides continuously.
Supine position	Active comparator	Other: Supine PositioningParticipants will remain in supine position with 30° head elevation. No lateralization therapy is applied.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Volunteers aged 18 or over;
Of both sexes;
Breathing through an orotracheal tube;
With respiratory and hemodynamic stability.

Key exclusion criteria (9 listed)

Patients with contraindications to change of position;
Acute spinal cord injury;
Unstable fractures and signs of intracranial hypertension;
Pregnant women;
Immediate postoperative period of thoracic, orthopedic and abdominal surgeries;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Automatic lateralization therapyAlso: Continuous lateral positioning, kinetic therapy, automated lateral rotation therapyProgram the bed to vary angle and time continuously during the intervention	Other	Automatic lateralization therapy
Supine PositioningAlso: Supine, Semi-recumbent position, Recumbent position, Dorsal decubitusIn this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°	Other	Supine position

Primary outcome

Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ)
Time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Represents the change in regional pulmonary aeration between the pre- and post-intervention moments.
Electrical impedance tomography (EIT): Ventilation Distribution Variation (ΔZ)
Time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Represents the change in ventilation distribution before and after the intervention.

3 secondary outcomes

Adverse events
Time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Respiratory Mechanics
Time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.
Vital signs
Time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Background: PubMed 20507660American Association for Respiratory Care. AARC Clinical Practice Guidelines. Endotracheal suctioning of mechanically ventilated patients with artificial airways 2010. Respir Care. 2010 Jun;55(6):758-64.
Background: PubMed 8324411Dittmer DK, Teasell R. Complications of immobilization and bed rest. Part 1: Musculoskeletal and cardiovascular complications. Can Fam Physician. 1993 Jun;39:1428-32, 1435-7.
Background: PubMed 8364672Doering LV. The effect of positioning on hemodynamics and gas exchange in the critically ill: a review. Am J Crit Care. 1993 May;2(3):208-16.
Background: PubMed 24364779Doerschug KC, Schmidt GA. Intensive care ultrasound: III. Lung and pleural ultrasound for the intensivist. Ann Am Thorac Soc. 2013 Dec;10(6):708-12. doi: 10.1513/AnnalsATS.201308-288OT. No abstract available.
Background: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
Background: PubMed 16556959Hassan AA, Evrensel CA, Krumpe PE. Clearance of viscoelastic mucus simulant with airflow in a rectangular channel, an experimental study. Technol Health Care. 2006;14(1):1-11.
Background: PubMed 11018445Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
Background: PubMed 30896557Kang SY, DiStefano MJ, Yehia F, Koszalka MV, Padula WV. Critical Care Beds With Continuous Lateral Rotation Therapy to Prevent Ventilator-Associated Pneumonia and Hospital-Acquired Pressure Injury: A Cost-effectiveness Analysis. J Patient Saf. 2021 Mar 1;17(2):149-155. doi: 10.1097/PTS.0000000000000582.
Background: PubMed 29430403Molina FJ, Rivera PT, Cardona A, Restrepo DC, Monroy O, Rodas D, Barrientos JG. Adverse events in critical care: Search and active detection through the Trigger Tool. World J Crit Care Med. 2018 Feb 4;7(1):9-15. doi: 10.5492/wjccm.v7.i1.9. eCollection 2018 Feb 4.
Background: PubMed 34976527Politi S, Aloisi A Jr, Bartoli V, Guglietta A, Magnifica F. Infrared Thermography Images Acquisition for a Technical Perspective in Screening and Diagnostic Processes: Protocol Standardized Acquisition. Cureus. 2021 Nov 27;13(11):e19931. doi: 10.7759/cureus.19931. eCollection 2021 Nov.
Background: PubMed 35150355Roldan R, Rodriguez S, Barriga F, Tucci M, Victor M, Alcala G, Villamonte R, Suarez-Sipmann F, Amato M, Brochard L, Tusman G. Sequential lateral positioning as a new lung recruitment maneuver: an exploratory study in early mechanically ventilated Covid-19 ARDS patients. Ann Intensive Care. 2022 Feb 12;12(1):13. doi: 10.1186/s13613-022-00988-9.
Background: PubMed 19789440Staudinger T, Bojic A, Holzinger U, Meyer B, Rohwer M, Mallner F, Schellongowski P, Robak O, Laczika K, Frass M, Locker GJ. Continuous lateral rotation therapy to prevent ventilator-associated pneumonia. Crit Care Med. 2010 Feb;38(2):486-90. doi: 10.1097/CCM.0b013e3181bc8218.
Multicare: cama articulável para cuidado intensivoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Upon reasonable request, anonymized data will be made available for scientific use, as: * Participant characteristics (age, gender) * Clinical measurements (blood pressure, heart rate) * Medical history * Clinical laboratory results * Adverse events (hemodynamic and respiratory instability, interruptions) * Details of treatment received

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shirley Lima Campos, PhD study director

Universidade Federal de Pernambuco

1 site in 1 country: see every site and its status.

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, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ) (time frame: In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.). The study lists 2 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 NCT07087600, which also lists 15 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 25 Nov 2025.