Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814994
• Other study ID #: ARDS protocol treatment
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 27, 2016
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2016
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Behavioral:
• tidal volume guided by respiratory system compliance
ventilated with tidal volume guided by respiratory system compliance
• low tidal volume
ventilation ventilated with low tidal volume

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the effects of tidal volume guided by respiratory system compliance on mortality in patients suffering from ARDS		28-days	Yes