NCT04734340

Brief Summary

This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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

January 1, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

January 28, 2021

Last Update Submit

January 28, 2021

Conditions

ARDSPulmonary Perfusion

Keywords

EITARDSpulmonary perfusion

Outcome Measures

Primary Outcomes (1)

  • ventilation free days

    1 Day

Secondary Outcomes (1)

  • 28-day mortality

    28 days

Study Arms (2)

EIT-guided group

EXPERIMENTAL

Treatment based on EIT

Procedure: EIT-guided PEEP setting

Control group

PLACEBO COMPARATOR

Treatment based on ARDS-net Peep setting

Procedure: ARDS-net PEEP setting

Interventions

EIT-guided PEEP settingPROCEDURE

Ventilator parameter setting by EIT

EIT-guided group
ARDS-net PEEP settingPROCEDURE

Ventilator parameter setting according to ARDS-net table

Control group

Eligibility Criteria

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

You may qualify if:

  • According to ARDS Berlin standard, ARDS, PaO2 / FiO2 \< 200mmhg, peep \> 5cmh2o;
  • According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
  • The subjects or their families signed informed consent.
  • Admission to ICU was less than 72 hours;
  • The estimated duration of mechanical ventilation was more than or equal to 48 hours;
  • Age ≥ 18 years old and ≤ 80 years old;

You may not qualify if:

  • The patients with heart implants could not be monitored by EIT;
  • Patients or their families refused to participate in the study;
  • Hypernatremia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Yun Long

CONTACT

13911608699ly_icu@aliyun.com

Siyi Yuan

CONTACT

15201518815yuansiyizqh@163.com

Study Design

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

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 2, 2021

Study Start

January 1, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)