NCT05816928

Brief Summary

Prone positioning has been widely used in critical care medicine to improve oxygenation in patients with acute respiratory distress syndrome (ARDS). This study aimed to compare the effect of pronation on lung ventilation-perfusion matching between COVID19-associated acute respiratory distress syndrome (CARDS) and ARDS from other etiologies (non-CARDS) using electrical impedance tomography (EIT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

April 5, 2023

Last Update Submit

April 17, 2023

Conditions

Keywords

Acute Respiratory Distress SyndromeICUCOVID19Electrical impedance tomography

Outcome Measures

Primary Outcomes (4)

  • DeadSpace

    The area of Deadspace will be assessed using electrical impedance tomography

    3 months

  • Shunt

    Shunt will be assessed using electrical impedance tomography

    3 months

  • Ventilation-perfusion matching (VQmatch)

    VQmatch will be assessed using electrical impedance tomography

    3 months

  • Global inhomogeneity index (VQmatch-GI)

    Within the defined VQmatch region assessed by electrical impedance tomography, the global inhomogeneity index (VQmatch-GI) was calculated to assess the degree of uniformity within the region.

    3 months

Secondary Outcomes (4)

  • Ventilation

    3 months

  • Perfusion

    3 months

  • Center of Ventilation (CoV)

    3 months

  • Standard deviation of regional ventilation delay

    3 months

Study Arms (2)

COVID19-associated ARDS (CARDS)

This group included COVID19 patients with acute respiratory distress syndrome. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning.

Non-COVID19-associated ARDS (non-CARDS)

This group included patients with acute respiratory distress syndrome from other etiologies. Patients were put under prone position while their pulmonary function was measured using EIT before and after proning.

Eligibility Criteria

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

The study population includes COVID19-associated ARDS patients and ARDS patients of other etiologies in the intensive care unit.

You may qualify if:

  • Above the age of 18
  • Diagnosed with ARDS based on the Berlin Definition of ARDS
  • Under mechanical ventilation

You may not qualify if:

  • Contraindications to EIT examination and prone position
  • Refusal of signing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PUMC

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Yang Y, Li H, Chi Y, Frerichs I, Zhao Z, Li Y, Zhang C, Chu H, He H, Long Y. Ventilation-perfusion matching in early-stage of prone position ventilation: a prospective cohort study between COVID-19 ARDS and ARDS from other etiologies. Physiol Meas. 2025 Jan 29;13(1). doi: 10.1088/1361-6579/ada8f1.

MeSH Terms

Conditions

Respiratory Distress SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Study Officials

  • Yun Long, MD

    Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

January 12, 2021

Primary Completion

April 12, 2021

Study Completion

April 12, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations