Immediate Effects of Automatic Lateralization in Critically Ill Patients

University of Pernambuco

Status: Completed

Conditions: Intensive Care Units

Treatments: Other: Supine Positioning; Other: Automatic lateralization therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07087600

70188523.0.0000.5200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Automatic lateralization therapy

Active Comparator group

Description:

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

Treatment:

Other: Automatic lateralization therapy

Supine position

Active Comparator group

Description:

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

Treatment:

Other: Supine Positioning