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the Influence of Tidal Volume to Lung Strain

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ClinicalTrials.gov Identifier: NCT01864668
Recruitment Status : Unknown
Verified May 2013 by Xiaohua Qiu, Zhongda Hospital.
Recruitment status was:  Recruiting
First Posted : May 29, 2013
Last Update Posted : February 11, 2014
Sponsor:
Information provided by (Responsible Party):
Xiaohua Qiu, Zhongda Hospital

Brief Summary:
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.

Condition or disease
Critically Ill Acute Respiratory Distress Syndrome

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.


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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: the Influence of Different Tidal Volume to Lung Strain of ARDS Patients
Study Start Date : June 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 28 days mortality [ Time Frame: 28 days ]
    Follow up to determine the mortality in 28 days after inclusion



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critical patients diagnosed with acute respiratory distress syndrome
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864668


Contacts
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Contact: Xiaohua Qiu, MD 0086-025-83262553 xiaohua0917@163.com
Contact: Fang Jin, MD 0086-15850601638 doris_king@163.com

Locations
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China, Jiangsu
Affiliated Zhongda Hospital of Southeast University Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Xiaohua Qiu, MD    0086-025-83262553    xiaohua0917@163.com   
Contact: Fang Jin, MD    0086-15850601638    doris_king@163.com   
Principal Investigator: Fang Jin, MD         
Sub-Investigator: Xiaohua Qiu, MD         
Sponsors and Collaborators
Zhongda Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaohua Qiu, physician, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT01864668     History of Changes
Other Study ID Numbers: 20130519
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: May 2013

Keywords provided by Xiaohua Qiu, Zhongda Hospital:
Acute respiratory distress syndrome
lung strain
small tidal volume

Additional relevant MeSH terms:
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Critical Illness
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury