Individualized PEEP Setting by EIT in Patients With ARDS

April 7, 2021 updated by: Peking Union Medical College Hospital

Individualized Positive End Expiratory Pressure(PEEP) Setting by EIT in Patients With Acute Respiratory Distress Syndrome(ARDS)

The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  1. acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)<300 and PEEP >5cmH2O
  2. Body mass index < =40
  3. Written inform consent

Exclusion:

  1. pregnant，intracranial hypertension
  2. left ventricular dysfunction (EF<25% )
  3. Patients with end-stage conditions(death expected within 90 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EIT group
the Individualized PEEP titration by EIT was administered to the patients in the EIT group.
Other: the EIT guide the individualized PEEP Setting
the EIT guide the individualized PEEP Setting in the EIT group
No Intervention: control group
If patients are assigned to the control group, the Individualized PEEP Setting was by PEEP-FiO2 table based on ARDS-net protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival
Time Frame: 28-day
Non-survive and survive
28-day
Arterial oxygenation
Time Frame: 72h
PaO2(mmHg) measured by blood gas analysis
72h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of ICU stay and mechanical ventilated day
Time Frame: 28days
Days of ICU stay and received mechanical ventilation(day)
28days
pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days;
Time Frame: 7days
new-onset of pneumothorax and barotrauma
7days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Yun Long, MD, Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PUMCH-ARDS-EIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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