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Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Primary Purpose

Respiratory Failure, Acute Respiratory Distress Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

tidal volume guided by respiratory system compliance

low tidal volume

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Zhongda Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

tidal volume guided by respiratory system compliance

low tidal volume

Arm Description

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

Ventilated patients with low tidal volume

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02814994

First Posted

June 20, 2016

Last Updated

June 27, 2016

Sponsor

Southeast University, China

1. Study Identification

Unique Protocol Identification Number

NCT02814994

Brief Title

Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Official Title

Respiratory System Compliance Guided Tidal Volume in Moderate to Severe ARDS Patients: A Multicenter Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southeast University, China

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure, Acute Respiratory Distress Syndrome

Keywords

Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tidal volume guided by respiratory system compliance

Arm Type

Experimental

Arm Description

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

Arm Title

low tidal volume

Arm Type

Experimental

Arm Description

Ventilated patients with low tidal volume

Intervention Type

Behavioral

Intervention Name(s)

tidal volume guided by respiratory system compliance

Intervention Description

ventilated with tidal volume guided by respiratory system compliance

Intervention Type

Behavioral

Intervention Name(s)

low tidal volume

Intervention Description

ventilation ventilated with low tidal volume

Primary Outcome Measure Information:

Title

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

Time Frame

28-days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: aged ≥ 18 years admitted to the ICU according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS Exclusion Criteria: age <18 years old be expected to die within 24 hours end-stage malignancies be participating in other studies, which may affect the results of this study DNI (do not intubation) and DNR (do not recovery) patients family members do not agree to sign an informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haibo Qiu, Prof.

Organizational Affiliation

southeast university

Official's Role

Study Director

Facility Information:

Facility Name

Zhongda Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

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