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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years.

Diagnosis of ARDS according to the Berlin Definition (2023 update).

Clinically evaluated as suitable for positional therapy by physicians.

Signed informed consent obtained from the patient or legal representative.

Disqualifiers

Pregnant or lactating women.

Severe cardiac diseases (e.g., unstable arrhythmia or heart failure) that may worsen with positional changes.

Severe coagulation disorders with increased bleeding risk.

Known allergy to the EIT device or any of its components.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Place the patient in the 90-degree high lateral position.

    Procedure/Surgery

    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/Surgery

    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/Surgery

    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/Surgery

    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.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: 90-degree high lateral position groupExperimental treatment 1 intervention
Group B: 30-degree low lateral position groupExperimental treatment 1 intervention
Group C: 120-degree high lateral position groupExperimental treatment 1 intervention
Group D: Prone position groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

death

Time frame
One month after treatment

Secondary outcomes

1

A/P Ratio

Time frame
24 hours before treatment, 24 hours after treatment
2

Ventilation-Perfusion Ratio

Time frame
24 hours before treatment, 24 hours after treatment
3

Oxygenation index

Time frame
24 hours before treatment, 24 hours after treatment
4

Global Inhomogeneity Index, GI

Time frame
24 hours before treatment, 24 hours after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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