NCT07083973

Brief Summary

To investigate global and regional changes in lung ventilation and perfusion induced by prone position in ARDS patients assessed by 3D-EIT. And to investigate the difference between 2D-EIT and 3D-EIT in prone position monitoring.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress70%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 31, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

November 14, 2024

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Regional ventilation monitored by EIT

    Using EIT to monitor the regional ventilation during supine and prone position, to monitor the ventilation distribution change.

    5-10minutes

  • Regional perfusion monitored by EIT

    Using EIT to monitor the regional perfusion during supine and prone position, to monitor the ventilation distribution change.

    5-10minutes

  • V/Q monitored by EIT

    Ventilation and perfusion monitored by EIT in supine and prone position. To evaluate the V/Q match, deadspace and shunt lung region.

    5-10minutes

Secondary Outcomes (2)

  • Respiratory system compliance

    1 day

  • SpO2

    1 day

Interventions

Prone positionBEHAVIORAL

Patients were ventilated based on the ARDS-Net recommendations . Patients were kept in a supine position. The process of lung ventilation and perfusion assessment was as follows: 1. PEEP was determined by the attending doctor and was kept the same during the supine and prone period. 2. 3D-EIT was used to monitor the ventilation and perfusion of ARDS patients at three timepoints: T1: supine position, T2: prone position at 30min, T3: prone position over 10 hours.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ARDS on mechanical ventilation

You may qualify if:

  • patients on mechanical ventilation.
  • Diagnosis of ARDS was based on the Berlin definition
  • Patients in need of prone position because of clinical condition

You may not qualify if:

  • Under 18 years of age.
  • Pregnant women;
  • Ribcage malformation
  • Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Acute Lung InjuryRespiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2024

First Posted

July 24, 2025

Study Start

October 31, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations