Individualized PEEP Setting by EIT in Patients With ARDS

NCT ID: NCT02361398

Last Updated: 2021-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2020-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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the PEEP Setting of ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EIT group

the Individualized PEEP titration by EIT was administered to the patients in the EIT group.

Group Type EXPERIMENTAL

the EIT guide the individualized PEEP Setting

Intervention Type OTHER

the EIT guide the individualized PEEP Setting in the EIT group

control group

If patients are assigned to the control group, the Individualized PEEP Setting was by PEEP-FiO2 table based on ARDS-net protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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the EIT guide the individualized PEEP Setting

the EIT guide the individualized PEEP Setting in the EIT group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun Long, MD

Role: STUDY_DIRECTOR

Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Locations

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Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.

Reference Type DERIVED
PMID: 34193224 (View on PubMed)

Other Identifiers

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PUMCH-ARDS-EIT

Identifier Type: -

Identifier Source: org_study_id

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