AnesthesiaLungbaroNCT02830516
Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods.
An observational study of Anesthesia, run by Stefan Lundin at 1 site in Sweden.
Trial summary
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Measurement of lung elastance by two methods
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2016to 31 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients which are anesthetized and muscle relaxed and are planned to undergo major surgery
Who may be able to join
- Patient undergoing major surgery during anesthesia and muscle relaxation
Who cannot join
- Patient with chronic obstructive lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.
Read the detailed description
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.
In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.
- Conditions
- Anesthesia
- Being tested
- Measurement of lung elastance by two methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of lung elastance by two methodsOther
Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume
| Study group | Role | What they receive |
|---|---|---|
| Lung elastance - transpulmonary pressure | Lung elastance and transpulmonary pressure measured by tidal esophageal pressure variations and by performing a PEEP step Receives: Other: Measurement of lung elastance by two methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of lung elastance
Comparison of two method for measurements of lung elastance (Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume)
Measured: At 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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 AnesthesiaStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefan Lundin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefan Lundin, Sahlgrenska University Hospital
- Investigators
- Stefan Lundin, Professor, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830516
- Sponsor's protocol ID
- LUA-74201
- Acronym
- Lungbaro
- Status last verified
- Jan 2018
- First submitted
- 21 Jun 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.
PubMed 29576127
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods
- ClinicalTrials.gov ID
- NCT02830516
- Acronym / sponsor ID
- Lungbaro / LUA-74201
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stefan LundinUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 13 Jul 2016 (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.
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.
Detailed description
Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.
In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung elastance - transpulmonary pressure | – | Other: Measurement of lung elastance by two methodsLung elastance and transpulmonary pressure measured by tidal esophageal pressure variations and by performing a PEEP step |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients which are anesthetized and muscle relaxed and are planned to undergo major surgery
Key inclusion criteria (1 listed)
- Patient undergoing major surgery during anesthesia and muscle relaxation
Key exclusion criteria (1 listed)
- Patient with chronic obstructive lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of lung elastance by two methodsMeasurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume | Other | Lung elastance - transpulmonary pressure |
Primary outcome
Measurement of lung elastance
Time frame: At 1 hour
Comparison of two method for measurements of lung elastance (Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume)
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 8 Jan 2018.
- Derived from this study: PubMed 29576127Persson P, Stenqvist O, Lundin S. Evaluation of lung and chest wall mechanics during anaesthesia using the PEEP-step method. Br J Anaesth. 2018 Apr;120(4):860-867. doi: 10.1016/j.bja.2017.11.076. Epub 2017 Dec 1.
- Individual participant dataSharing planned: Undecided
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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.
Stefan Lundin, Professor principal investigator
Sahlgrenska University Hospital
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 Anesthesia, run by Stefan Lundin at 1 site in Sweden.
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 1 inclusion and 1 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 8 Jan 2018. 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 Sweden. 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?
Measurement of lung elastance (time frame: At 1 hour). 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 NCT02830516, 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 8 Jan 2018.