Critically IllNCT01864668
the Influence of Tidal Volume to Lung Strain
An observational study of Critically Ill and Acute Respiratory Distress Syndrome, run by Zhongda Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critically Ill, Acute Respiratory Distress Syndrome
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical patients diagnosed with acute respiratory distress syndrome
Who may be able to join
- Age:18-85,gender is not limited
- Needing Invasive ventilation
- Fit the definition of ARDS in 2012 "Berlin Definition"
- Sign the paper of informed consent
Who cannot join
- pregnancy and at the end stage of tumour
- the COPD patients
- less than 24h of mechanical ventilation
- more than 5 days of mechanical ventilation
- FiO2>80%
- presence of air leaks
- organ dysfunction and hemodynamic instability
- including in other research
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210009
Xiaohua Qiu, MD, 0086-025-83262553, xiaohua0917@163.com
Fang Jin, MD, 0086-15850601638, doris_king@163.com
About this study
Official title: 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.
Read the 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.
- Keywords
- Acute respiratory distress syndrome, lung strain, small tidal volume
- Medical subject headings
- Critical Illness, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
the strain in different tidal volume
Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)
Measured: 2 hours
Secondary outcomes (1)
28 days mortality
Follow up to determine the mortality in 28 days after inclusion
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Qiu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864668
- Sponsor's protocol ID
- 20130519
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x.
PubMed 28159013
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Influence of Different Tidal Volume to Lung Strain of ARDS Patients
- ClinicalTrials.gov ID
- NCT01864668
- Acronym / sponsor ID
- 20130519
- Keywords
- Acute respiratory distress syndrome, lung strain, small tidal volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical patients diagnosed with acute respiratory distress syndrome
Key inclusion criteria (4 listed)
- Age:18-85,gender is not limited
- Needing Invasive ventilation
- Fit the definition of ARDS in 2012 "Berlin Definition"
- Sign the paper of informed consent
Key exclusion criteria (8 listed)
- pregnancy and at the end stage of tumour
- the COPD patients
- less than 24h of mechanical ventilation
- more than 5 days of mechanical ventilation
- FiO2>80%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
28 days mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Derived from this study: PubMed 28159013Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Acute Respiratory Distress Syndrome, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Qiu, MD (0086-025-83262553, xiaohua0917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the strain in different tidal volume (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01864668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014; AzTrials last refreshed its copy on 6 Nov 2026.