the Influence of Tidal Volume to Lung Strain

February 8, 2014 updated by: Xiaohua Qiu, Zhongda Hospital

the Influence of Different Tidal Volume to Lung Strain of ARDS Patients

Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.

Study Overview

Detailed Description

Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value.

Methods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient.

Hypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Affiliated Zhongda Hospital of Southeast University
        • Contact:
        • Sub-Investigator:
          • Xiaohua Qiu, MD
        • Contact:
        • Principal Investigator:
          • Fang Jin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Critical patients diagnosed with acute respiratory distress syndrome

Description

Inclusion Criteria:

  1. Age:18-85,gender is not limited
  2. Needing Invasive ventilation
  3. Fit the definition of ARDS in 2012 "Berlin Definition"
  4. Sign the paper of informed consent

Exclusion Criteria:

  1. pregnancy and at the end stage of tumour
  2. the COPD patients
  3. less than 24h of mechanical ventilation
  4. more than 5 days of mechanical ventilation
  5. FiO2>80%
  6. presence of air leaks
  7. organ dysfunction and hemodynamic instability
  8. including in other research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the strain in different tidal volume
Time Frame: 2 hours
Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 days mortality
Time Frame: 28 days
Follow up to determine the mortality in 28 days after inclusion
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 8, 2014

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome

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