NCT04725227

Brief Summary

determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 25, 2021

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Assess regional distribution of pulmonary perfusion

    To evaluate the effect of prone positon on pulmonary blood flow distribution.

    within 24 hours

  • Assess regional distribution of pulmonary ventilation

    To evaluate the effect of prone positon on pulmonary vetilation distribution.

    within 24 hours

  • Assess oxygenation status

    To evaluate the effect of prone position by assessing regional distribution of pulmonary perfusion based on indicator dilution and changes at different points in time during varying states of regional ventilation will be evaluated.

    within 24 hours

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requiring mechanical ventilation are recieved prone position ventilation who admitted to the surgical ICU.

You may qualify if:

  • patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio \< 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition

You may not qualify if:

  • contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

  • Wang Y, Muhetaer Y, Zheng X, Wu W, Tao J, Zhu L, Song J, Zhao Z, Zhong M. Time-dependent effects of prone position on ventilation-perfusion matching assessed by electrical impedance tomography in patients with COVID-19 ARDS: sub-analysis of a prospective physiological study. Ann Intensive Care. 2025 Mar 31;15(1):46. doi: 10.1186/s13613-025-01452-0.

  • Wang Y, Song J, Lin S, Zheng X, Zhao Z, Zhong M. Influence of Prone Position on Regional Ventilation/Perfusion Matching in Patients With ARDS Over Time. Respir Care. 2025 Jul;70(7):821-829. doi: 10.1089/respcare.12247. Epub 2025 Mar 5.

  • Wang YX, Zhong M, Dong MH, Song JQ, Zheng YJ, Wu W, Tao JL, Zhu L, Zheng X. Prone positioning improves ventilation-perfusion matching assessed by electrical impedance tomography in patients with ARDS: a prospective physiological study. Crit Care. 2022 May 27;26(1):154. doi: 10.1186/s13054-022-04021-0.

Study Officials

  • Ming Zhong, MD, phD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 26, 2021

Study Start

December 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations