Immediate Effects of Automatic Lateralization in Critically Ill Patients

NCT ID: NCT07087600

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-14

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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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

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Intensive Care Units

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Automatic lateralization therapy

Participants will undergo automatic lateral positioning using a motorized bed programmed to alternate angles of 0°, 15°, and 30°, switching sides continuously.

Group Type ACTIVE_COMPARATOR

Automatic lateralization therapy

Intervention Type OTHER

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

Supine position

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

Group Type ACTIVE_COMPARATOR

Supine Positioning

Intervention Type OTHER

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

Interventions

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Automatic lateralization therapy

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

Intervention Type OTHER

Supine Positioning

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

Intervention Type OTHER

Other Intervention Names

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Continuous lateral positioning kinetic therapy automated lateral rotation therapy Supine Semi-recumbent position Recumbent position Dorsal decubitus Conventional supine care

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role collaborator

Coordination for the Improvement of Higher Education Personnel

OTHER

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Ciência e Tecnologia de Pernambuco

OTHER

Sponsor Role collaborator

University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Shirley Lima Campos

Principal Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shirley Lima Campos, PhD

Role: STUDY_DIRECTOR

Universidade Federal de Pernambuco

Locations

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Hospital Geral Otávio de Freitas

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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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.

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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.

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Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 35150355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19789440 (View on PubMed)

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

Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND
PMID: 22229679 (View on PubMed)

Related Links

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Other Identifiers

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70188523.0.0000.5200

Identifier Type: -

Identifier Source: org_study_id

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