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NCT Number: NCT02814994

Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients

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.

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Key information

Conditions

Respiratory Failure Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tidal volume guided by respiratory system compliance

Behavioral

ventilated with tidal volume guided by respiratory system compliance

low tidal volume

Behavioral

ventilation ventilated with low tidal volume

Primary outcomes

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

    Time frame: 28-days

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2016
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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