the Influence of Tidal Volume to Lung Strain

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01864668
• Other study ID #: 20130519
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: February 8, 2014
• Start date: June 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2013
• Source: Zhongda Hospital
• Contact: Xiaohua Qiu, MD
• Phone: 0086-025-83262553
• Email: xiaohua0917[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Critical Illness
• Critically Ill
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
China	Affiliated Zhongda Hospital of Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the strain in different tidal volume	Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)	2 hours	Yes
Secondary	28 days mortality	Follow up to determine the mortality in 28 days after inclusion	28 days	Yes