Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

Southeast University, China

Status: Completed

Conditions: Respiratory Failure; Acute Respiratory Distress Syndrome

Treatments: Behavioral: tidal volume guided by respiratory system compliance; Behavioral: low tidal volume

Study type: Interventional

Funder types: Other

Identifiers

NCT02814994

ARDS protocol treatment

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

tidal volume guided by respiratory system compliance

Experimental group

Description:

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

Treatment:

Behavioral: tidal volume guided by respiratory system compliance

low tidal volume

Experimental group

Description:

Ventilated patients with low tidal volume

Treatment:

Behavioral: low tidal volume