Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients

N/ANot Yet RecruitingNCT07375849

The Fourth Affiliated Hospital of Zhejiang University School of Medicine140 enrolled

Overview

This randomized controlled trial investigates the effects of prone positioning versus lateral positioning at different angles (30°, 90°, 120°) on pulmonary function improvement in patients with acute respiratory distress syndrome (ARDS). Utilizing electrical impedance tomography (EIT) technology, the study monitors key parameters including ventilation distribution and ventilation-perfusion matching in real time, while integrating respiratory mechanics and blood gas analysis data to comprehensively evaluate the therapeutic efficacy of positional adjustments. The study hypothesizes that high-angle lateral positioning may reduce adverse complications associated with prone positioning while effectively improving oxygenation and pulmonary function. The ultimate objective is to provide a safer and more personalized positional therapy regimen for clinical practice, optimizing ARDS treatment strategies to reduce mortality and enhance patient survival outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Interventions

For the 90° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points.

Place the patient in the 30-degree low lateral position.PROCEDURE

For the 30° lateral recumbent position group, patients will be rotated between left and right lateral recumbent positions at the corresponding angles every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed beneath the patient's back and buttocks to alleviate pressure points. Translated with DeepL.com (free version)

Place the patient in the 120-degree high lateral position.PROCEDURE

For the 120° lateral recumbent position group, patients will be rotated between corresponding lateral recumbent positions on the left and right sides every 2 hours, spending 8 hours on each side for a total treatment duration of 16 hours. During each rotation, the nursing team will ensure the patient is safely transferred from one side to the other while maintaining the prescribed lateral angle. Wedge pillows or specialized turning pads will be used to assist in positioning, with supports placed under the patient's back and buttocks to alleviate pressure points. Translated with DeepL.com (free version)

Patients will be placed in the prone position, i.e., lying face down.PROCEDURE

Patients will be positioned in the prone position, lying face down, with specialized prone positioning devices or pillows supporting the head and chest to ensure airway patency. Daily prone therapy duration is set according to clinical guidelines, typically lasting 16 hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>= 18 years. 2. Diagnosis of ARDS according to the Berlin Definition (2023 update). 3. Clinically evaluated as suitable for positional therapy by physicians. 4. Signed informed consent obtained from the patient or legal representative. 5. Absence of severe spinal deformities or musculoskeletal disorders that may compromise safe high lateral positioning. 6. No severe skin conditions (e.g., extensive open wounds or pressure ulcers) that may affect the feasibility of lateral positioning. Exclusion Criteria: 1. Pregnant or lactating women. 2. Severe cardiac diseases (e.g., unstable arrhythmia or heart failure) that may worsen with positional changes. 3. Severe coagulation disorders with increased bleeding risk. 4. Known allergy to the EIT device or any of its components. 5. Severe psychiatric disorders impairing study compliance. 6. Current participation in experimental therapies that may affect pulmonary function. 7. Severe active infections requiring special isolation measures. 8. Anticipated need for emergency surgery or life-threatening complications within 24 hours.

Outcomes

Primary Outcomes

death

Time frame: One month after treatment

Secondary Outcomes

A/P Ratio

Time frame: 24 hours before treatment, 24 hours after treatment

Ventilation-Perfusion Ratio

Time frame: 24 hours before treatment, 24 hours after treatment

Oxygenation index

Time frame: 24 hours before treatment, 24 hours after treatment

Global Inhomogeneity Index, GI

Time frame: 24 hours before treatment, 24 hours after treatment

Application of Electrical Impedance Tomography in Evaluating Pulmonary Function Improvement After High Lateral Recumbent Position Therapy in ARDS Patients

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts