Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Respiratory Failure

• Registration Number: NCT02814994
• Lead Sponsor: Southeast University, China

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.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS	28-days

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China