NCT07087600

Immediate Effects of Automatic Lateralization in Critically Ill Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Pernambuco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	Automatic lateralization therapy	Program the bed to vary angle and time continuously during the intervention
OTHER	Supine Positioning	In this intervention, participants will be positioned in the supine position with the head of the bed elevated at 30°

Timeline

• Start date: 2025-08-14
• Primary completion: 2025-09-30
• Completion: 2025-10-30
• First posted: 2025-07-28
• Last updated: 2025-11-25

Locations

1 site across 1 country: Brazil