The Study of EIT-guided Ventilation Strategy on ARDS Patients

NCT ID: NCT04734340

Last Updated: 2021-02-02

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-06-01

Brief Summary

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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

Detailed Description

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Conditions

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ARDS Pulmonary Perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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EIT-guided group

Treatment based on EIT

Group Type EXPERIMENTAL

EIT-guided PEEP setting

Intervention Type PROCEDURE

Ventilator parameter setting by EIT

Control group

Treatment based on ARDS-net Peep setting

Group Type PLACEBO_COMPARATOR

ARDS-net PEEP setting

Intervention Type PROCEDURE

Ventilator parameter setting according to ARDS-net table

Interventions

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EIT-guided PEEP setting

Ventilator parameter setting by EIT

Intervention Type PROCEDURE

ARDS-net PEEP setting

Ventilator parameter setting according to ARDS-net table

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. The patients with heart implants could not be monitored by EIT;
2. Patients or their families refused to participate in the study;
3. Hypernatremia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Long

Role: CONTACT

13911608699

Siyi Yuan

Role: CONTACT

15201518815

Facility Contacts

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Yun Long

Role: primary

13911608699

Siyi Yuan

Role: backup

15201518815

Other Identifiers

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EIT-RCT

Identifier Type: -

Identifier Source: org_study_id

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