Airway Pressure Stress IndexNCT02196870
Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)
An observational study of Airway Pressure Stress Index and Transpulmonary Pressure Stress Index, run by Southeast University, China at 1 site in China.
Trial summary
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Airway Pressure Stress Index, Transpulmonary Pressure Stress Index, Acute Respiratory Failure
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jun 2015
- How long will I take part?
- 3 Years
- 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: acute respiratory failure patients
Who may be able to join
- ARF
- mechanical ventilation
- cardiovascular stable
Who cannot join
- age < 18y or > 85y
- pregnancy
- COPD or chronic pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure Patientstranspulmonary Pressure
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.
Read the detailed description
Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2.
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.
The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.
- Conditions
- Airway Pressure Stress Index, Transpulmonary Pressure Stress Index, Acute Respiratory Failure, Chest Wall Elastance
- Keywords
- Airway pressure stress index, Transpulmonary pressure stress index, Acute Respiratory Failure, Chest wall elastance, Lung stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of oxygenation and lung mechanics
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
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 Airway Pressure Stress IndexStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Jianfeng Xie, Dr., Principal investigator, Zhongda hospital, Southeast University, Jiangsu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196870
- Sponsor's protocol ID
- Chest wall Elastance in ARF
- Status last verified
- Jun 2015
- First submitted
- 12 Jul 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pan C, Chen L, Zhang YH, Liu W, Urbino R, Ranieri VM, Qiu HB, Yang Y. Physiological Correlation of Airway Pressure and Transpulmonary Pressure Stress Index on Respiratory Mechanics in Acute Respiratory Failure. Chin Med J (Engl). 2016 Jul 20;129(14):1652-7. doi: 10.4103/0366-6999.185855.
PubMed 27411451
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure Patientstranspulmonary Pressure
- ClinicalTrials.gov ID
- NCT02196870
- Acronym / sponsor ID
- Chest wall Elastance in ARF
- Conditions
- Airway Pressure Stress Index, Transpulmonary Pressure Stress Index, Acute Respiratory Failure, Chest Wall Elastance
- Keywords
- Airway pressure stress index, Transpulmonary pressure stress index, Acute Respiratory Failure, Chest wall elastance, Lung stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Jul 2014 (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.
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.
Detailed description
Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF) patients, could improve hypoxemia, maintain lung volume and promote alveolar opening. However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients with normal lung function1,2.
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest wall elastance plays a great role in lung mechanics, and could influence mechanical ventilation settings. Therefore, It could help the physicians to find appropriate indicators and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics changse in the patients with high chest wall elastance.
The present study is set out to examine the effects of high chest wall elastance on changes of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary pressure(PL) stress index.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute respiratory failure patients
Key inclusion criteria (3 listed)
- ARF
- mechanical ventilation
- cardiovascular stable
Key exclusion criteria (3 listed)
- age < 18y or > 85y
- pregnancy
- COPD or chronic pulmonary disease
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
Changes of oxygenation and lung mechanics
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Derived from this study: PubMed 27411451Pan C, Chen L, Zhang YH, Liu W, Urbino R, Ranieri VM, Qiu HB, Yang Y. Physiological Correlation of Airway Pressure and Transpulmonary Pressure Stress Index on Respiratory Mechanics in Acute Respiratory Failure. Chin Med J (Engl). 2016 Jul 20;129(14):1652-7. doi: 10.4103/0366-6999.185855.
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.
Jianfeng Xie, Dr. principal investigator
Zhongda hospital, Southeast University, Jiangsu, China
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 Airway Pressure Stress Index and Transpulmonary Pressure Stress Index, run by Southeast University, China 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of oxygenation and lung mechanics (time frame: up to 24 months). 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 NCT02196870, 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 24 Jun 2015.