NCT05207267

Brief Summary

A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

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

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

August 20, 2021

Last Update Submit

August 23, 2023

Conditions

ARDS

Keywords

ARDSventilation and perfusion matchingventilation inhomogeneity

Outcome Measures

Primary Outcomes (8)

  • regional compliance using EIT

    regional compliance using EIT

    Day 1

  • regional ventilation

    regional ventilation using EIT

    Day 1

  • regional perfusion

    regional perfusion using EIT

    Day 1

  • Region-ventilation-delay

    Region-ventilation-delay using EIT

    Day 1

  • driving pressure

    measurement as one index of respiratory compliance

    Day 3

  • the number of regional lung ventilation

    regional ventilation measuring by EIT

    Day 3

  • the number of regional lung perfusion

    regional perfusion measuring by EIT

    Day 3

  • the number of region-ventilation-delay (RVD)

    the RVD measuring by EIT

    Day 3

Secondary Outcomes (9)

  • Value of ventilation-perfusion (V/Q) mismatch

    Day 1

  • Value of ventilation-perfusion (V/Q) mismatch

    Day 3

  • Value of ventilation-perfusion (V/Q) mismatch

    Day 7

  • The Global Inhomogeneity (GI) index

    Day 1

  • The Global Inhomogeneity (GI) index

    Day 3

  • +4 more secondary outcomes

Study Arms (1)

testing arm

EXPERIMENTAL

ventilated with different VT using an EIT monitor (PulmoVista® 500, Dräger, Lübeck, Germany)

Device: driving pressure guided tidal volume

Interventions

driving pressure guided tidal volumeDEVICE

Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position.

testing arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged ≥ 18 years old
  • admitted to intensive care unit with a moderate to severe ARDS
  • invasive mechanical ventilation

You may not qualify if:

  • contraindications for prone position ventilation
  • Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
  • New York Heart Association class above II
  • gave written or witnessed verbal informed consent.
  • Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
  • Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Liu

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • Yuan X, Zhao Z, Chao Y, Chen D, Chen H, Zhang R, Liu S, Xie J, Yang Y, Qiu H, Heunks L, Liu L. Effects of early versus delayed application of prone position on ventilation-perfusion mismatch in patients with acute respiratory distress syndrome: a prospective observational study. Crit Care. 2023 Nov 27;27(1):462. doi: 10.1186/s13054-023-04749-3.

    PMID: 38012731DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ling Liu

    Zhongda Hospital, School of Medicine, Southeast Univerty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

August 20, 2021

First Posted

January 26, 2022

Study Start

June 30, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

by email

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
with in two years after publication
Access Criteria
other researchers

Locations

CN(1)