Immediate Effects on Ventilatory Morphofunctional Pattern and Cardiorespiratory Safety During Automatic Body Lateralization Therapy in Critically Ill Patients: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers aged 18 or over;
- •Of both sexes;
- •Breathing through an orotracheal tube;
- •With respiratory and hemodynamic stability.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Automatic lateralization therapy (Other)
Supine position
Participants will remain in supine position with 30° head elevation. No lateralization therapy is applied.
干预措施: Supine Positioning (Other)
结局指标
主要结局
Electrical impedance tomography (EIT): End-Expiratory Electrical Impedance Variation (ΔEELZ)
时间窗: 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.
Electrical impedance tomography (EIT): Ventilation Distribution Variation (ΔZ)
时间窗: 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.
次要结局
- 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.)
- 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.)
研究者
Shirley Lima Campos
Principal Researcher
University of Pernambuco