Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

NCT ID: NCT02814994

Last Updated: 2016-06-28

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

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-06-30

Brief Summary

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The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.

Detailed Description

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From September 1st 2012 to September 30th 2014, all ARDS patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Conditions

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Respiratory Failure Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tidal volume guided by respiratory system compliance

effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS

Group Type EXPERIMENTAL

tidal volume guided by respiratory system compliance

Intervention Type BEHAVIORAL

ventilated with tidal volume guided by respiratory system compliance

low tidal volume

Ventilated patients with low tidal volume

Group Type EXPERIMENTAL

low tidal volume

Intervention Type BEHAVIORAL

ventilation ventilated with low tidal volume

Interventions

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tidal volume guided by respiratory system compliance

ventilated with tidal volume guided by respiratory system compliance

Intervention Type BEHAVIORAL

low tidal volume

ventilation ventilated with low tidal volume

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. aged ≥ 18 years
2. admitted to the ICU
3. according to the diagnostic criteria of ARDS Berlin definition,admit patients with severe ARDS

Exclusion Criteria

1. age \<18 years old
2. be expected to die within 24 hours
3. end-stage malignancies
4. be participating in other studies, which may affect the results of this study
5. DNI (do not intubation) and DNR (do not recovery) patients
6. family members do not agree to sign an informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Chun Pan

physician, Zhongda Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haibo Qiu, Prof.

Role: STUDY_DIRECTOR

southeast university

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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ARDS protocol treatment

Identifier Type: -

Identifier Source: org_study_id

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