Skip to main content
OpenTrials
Completed

NCT Number: NCT07087600

Immediate Effects of Automatic Lateralization in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intensive Care Units Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Geral Otávio de Freitas

Recife, Pernambuco, 50920-460, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automatic lateralization therapy

Other

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

Other names: Continuous lateral positioning, kinetic therapy, automated lateral rotation therapy

Supine positioning

Other

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

Other names: Supine, Semi-recumbent position, Recumbent position, Dorsal decubitus, Conventional supine care

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

    Monitoring of serious and non-serious adverse events associated with the intervention through an adapted adverse event form

  2. 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.

    Data provided through the mechanical ventilator and from inspiratory and expiratory pause maneuvers

  3. 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.

    Viewed on the multiparameter monitor

Other outcomes

  1. Lung morphofunctional pattern

    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.

    Type of pattern of lung alteration observed by functional electrical impedance tomography image (preserved, unilateral involvement, unilateral dorsal, bilateral, bilateral dorsal).

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.