Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02814994

Enrollment

242

Registered

2016-06-28

Start date

2012-09-30

Completion date

2014-06-30

Last updated

2016-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Acute Respiratory Distress Syndrome

Keywords

Mechanical Ventilation, ARDS, Ventilator Strategy, Outcome

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.

Interventions

BEHAVIORALtidal volume guided by respiratory system compliance

ventilated with tidal volume guided by respiratory system compliance

BEHAVIORALlow tidal volume

ventilation ventilated with low tidal volume

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026