NCT07375849

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Dec 2027

Study Start

First participant enrolled

January 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

  • death

    One month after treatment

Secondary Outcomes (4)

  • A/P Ratio

    24 hours before treatment, 24 hours after treatment

  • Ventilation-Perfusion Ratio

    24 hours before treatment, 24 hours after treatment

  • Oxygenation index

    24 hours before treatment, 24 hours after treatment

  • Global Inhomogeneity Index, GI

    24 hours before treatment, 24 hours after treatment

Study Arms (4)

90-degree high lateral position group

EXPERIMENTAL

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

Procedure: Place the patient in the 90-degree high lateral position.

30-degree low lateral position group

EXPERIMENTAL

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

Procedure: Place the patient in the 30-degree low lateral position.

120-degree high lateral position group

EXPERIMENTAL

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

Procedure: Place the patient in the 120-degree high lateral position.

Prone position group

ACTIVE COMPARATOR

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

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

Interventions

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)

30-degree low lateral position group
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)

120-degree high lateral position group
Place the patient in the 90-degree high lateral position.PROCEDURE

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.

90-degree high lateral position group
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.

Prone position group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Absence of severe spinal deformities or musculoskeletal disorders that may compromise safe high lateral positioning.
  • No severe skin conditions (e.g., extensive open wounds or pressure ulcers) that may affect the feasibility of lateral positioning.

You may not qualify if:

  • 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.
  • Severe psychiatric disorders impairing study compliance.
  • Current participation in experimental therapies that may affect pulmonary function.
  • Severe active infections requiring special isolation measures.
  • Anticipated need for emergency surgery or life-threatening complications within 24 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Lijun Song

CONTACT

+8615869252244lijun-song@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01