Immediate Effects of Automatic Lateralization in Critically Ill Patients

NCT07087600 | Completed DMC

• 1 other identifier: 70188523.0.0000.5200
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intensive Care Units

Keywords

Automatic lateralization therapy; Critical illness; Continuous lateral rotation; Electrical impedance tomography

Outcome Measures

Primary Outcomes (2)

• Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ)

  Represents the change in regional pulmonary aeration between the pre- and post-intervention moments.

  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.

  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

  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

  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

  In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.

Other Outcomes (1)

• Lung morphofunctional pattern

  In the 5 minutes of each angulation, totaling 15 minutes in the unilateral morphofunctional pattern or 20 minutes in the bilateral morphofunctional pattern.

Study Arms (2)

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.

Other: Automatic lateralization therapy

Supine position

ACTIVE COMPARATOR

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

Other: Supine Positioning

Interventions

Automatic lateralization therapy OTHER

Program the bed to vary angle and time continuously during the intervention

Also known as: Continuous lateral positioning, kinetic therapy, automated lateral rotation therapy

Automatic lateralization therapy

Supine Positioning OTHER

In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°

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

Supine position

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pernambuco: lead
• Universidade Federal de Pernambuco: collaborator
• Coordination for the Improvement of Higher Education Personnel: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Ciência e Tecnologia de Pernambuco: collaborator

Study Sites (1)

Hospital Geral Otávio de Freitas

Recife, Pernambuco, 50920-460, Brazil

Location

Related Publications (15)

• 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.

  PMID: 20507660 BACKGROUND

• Maclin VM, Radwanska E, Binor Z, Dmowski WP. Progesterone:estradiol ratios at implantation in ongoing pregnancies, abortions, and nonconception cycles resulting from ovulation induction. Fertil Steril. 1990 Aug;54(2):238-44. doi: 10.1016/s0015-0282(16)53696-6.

  PMID: 2379624 BACKGROUND

• 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.

  PMID: 8364672 BACKGROUND

• 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.

  PMID: 24364779 BACKGROUND

• 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.

  PMID: 27596161 BACKGROUND

• 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.

  PMID: 16556959 BACKGROUND

• 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.

  PMID: 11018445 BACKGROUND

• 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.

  PMID: 30896557 BACKGROUND

• 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.

  PMID: 29430403 BACKGROUND

• 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.

  PMID: 34976527 BACKGROUND

• 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.

  PMID: 35150355 BACKGROUND

• 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.

  PMID: 19789440 BACKGROUND

• Teasell R, Dittmer DK. Complications of immobilization and bed rest. Part 2: Other complications. Can Fam Physician. 1993 Jun;39:1440-2, 1445-6.

  PMID: 8324412 BACKGROUND

• 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.

  PMID: 32712584 BACKGROUND

• 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.

  PMID: 22229679 BACKGROUND

Related Links

• Multicare: cama articulável para cuidado intensivo

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

• Shirley Lima Campos, PhD

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: July 28, 2025
• Study Start: August 14, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: End of trial
• 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 medical and clinical characteristics. A committee of researchers will be in charge of discussing the request before approving the access.

Locations

BR (1)