AtelectasisNCT03352336
Estimation of Perioperative Atelectasis
An observational study of Atelectasis and Oxygenation, run by Region Västmanland at 1 site in Sweden.
Trial summary
This study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Atelectasis, Oxygenation
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 4 Dec 2017to 28 Aug 2018
- 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 40 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients fulfilling inclusion and exclusion criteria while attending the day case department of Köping county hospital in Region Västmanland.
Who may be able to join
- American Society of Anesthesiology (ASA) class I-II.
- Non-abdominal day case surgery under general anesthesia.
- Patients enrolled in study registered in ClinicalTrials with NCT ID.
Who cannot join
- Arterial oxygen saturation (SpO2) <90 % with 40% Venturi mask.
- Unstable postoperative condition needing immediate treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Two Methods for Estimating the Extent of Perioperative Atelectasis
This study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis.
Read the detailed description
Computed tomography of the lungs is the gold standard for investigating the extent of atelectasis, which is common in the perioperative setting. Atelectasis increase the risk of postoperative pulmonary complications and result in pulmonary shunt, which is one of the two major causes of impaired oxygenation. The other cause is admixture of venous blood from poorly ventilated regions of the lungs. The investigators have developed an oxygenation test utilizing arterial blood gas analysis at different inspired fractions of oxygen, which may be used to distinguish between these two causes. This observational study aims to establish the agreement between computed tomography and the oxygenation test for estimating the extent of atelectasis.
- Conditions
- Atelectasis, Oxygenation
- Keywords
- Atelectasis, Oxygenation, Venous admixture, Computed Tomography, Oxygenation test
- Medical subject headings
- Pulmonary Atelectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis area
Atelectasis area as studied by computed tomography
Measured: 30 min after emergence from anesthesia
Secondary outcomes (1)
Pulmonary shunt estimated by a standardised oxygenation test
Pulmonary shunt estimated by a standardised oxygenation test using
Measured: 30 min after emergence from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start4 Dec 2017
- Primary completion28 Aug 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Edmark, Region Västmanland
- Investigators
- Lennart Edmark, M.D., Ph.D., Study director, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352336
- Sponsor's protocol ID
- Dnr 2017/27:2
- Status last verified
- Oct 2018
- First submitted
- 19 Nov 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome will be available.
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Methods for Estimating the Extent of Perioperative Atelectasis
- ClinicalTrials.gov ID
- NCT03352336
- Acronym / sponsor ID
- Dnr 2017/27:2
- Conditions
- Atelectasis, Oxygenation
- Keywords
- Atelectasis, Oxygenation, Venous admixture, Computed Tomography, Oxygenation test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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.
This study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis.
Detailed description
Computed tomography of the lungs is the gold standard for investigating the extent of atelectasis, which is common in the perioperative setting. Atelectasis increase the risk of postoperative pulmonary complications and result in pulmonary shunt, which is one of the two major causes of impaired oxygenation. The other cause is admixture of venous blood from poorly ventilated regions of the lungs. The investigators have developed an oxygenation test utilizing arterial blood gas analysis at different inspired fractions of oxygen, which may be used to distinguish between these two causes. This observational study aims to establish the agreement between computed tomography and the oxygenation test for estimating the extent of atelectasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients fulfilling inclusion and exclusion criteria while attending the day case department of Köping county hospital in Region Västmanland.
Key inclusion criteria (3 listed)
- American Society of Anesthesiology (ASA) class I-II.
- Non-abdominal day case surgery under general anesthesia.
- Patients enrolled in study registered in ClinicalTrials with NCT ID.
Key exclusion criteria (2 listed)
- Arterial oxygen saturation (SpO2) <90 % with 40% Venturi mask.
- Unstable postoperative condition needing immediate treatment.
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
Atelectasis area
Time frame: 30 min after emergence from anesthesia
Atelectasis area as studied by computed tomography
1 secondary outcome
Pulmonary shunt estimated by a standardised oxygenation test
Time frame: 30 min after emergence from anesthesia
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 12 Oct 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome will be available.
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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.
Lennart Edmark, M.D., Ph.D. study director
Region Västmanland
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 Atelectasis and Oxygenation, run by Region Västmanland 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 3 inclusion and 2 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 12 Oct 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?
Atelectasis area (time frame: 30 min after emergence from anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2018; AzTrials last refreshed its copy on 3 Nov 2026.