Estimation of Perioperative Atelectasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03352336
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : October 12, 2018
Information provided by (Responsible Party):
Lennart Edmark, Region Västmanland

Brief Summary:
This study will compare an oxygenation test based on arterial blood gas analysis with computed tomography for estimating the extent of atelectasis.

Condition or disease
Atelectasis Oxygenation

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 Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison Between Two Methods for Estimating the Extent of Perioperative Atelectasis
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Primary Outcome Measures :
  1. Atelectasis area [ Time Frame: 30 min after emergence from anesthesia ]
    Atelectasis area as studied by computed tomography

Secondary Outcome Measures :
  1. Pulmonary shunt estimated by a standardised oxygenation test [ Time Frame: 30 min after emergence from anesthesia ]
    Pulmonary shunt estimated by a standardised oxygenation test using

Biospecimen Retention:   Samples With DNA
Arterial blood gases

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients fulfilling inclusion and exclusion criteria while attending the day case department of Köping county hospital in Region Västmanland.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Arterial oxygen saturation (SpO2) <90 % with 40% Venturi mask.
  • Unstable postoperative condition needing immediate treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03352336

Västmanlands sjukhus Köping
Köping, Västmanland, Sweden, 73181
Sponsors and Collaborators
Region Västmanland
Study Director: Lennart Edmark, M.D., Ph.D. Region Västmanland

Responsible Party: Lennart Edmark, Principal Investigator, Region Västmanland Identifier: NCT03352336     History of Changes
Other Study ID Numbers: Dnr 2017/27:2
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by the board of the local clinical research center in Region Vastmanland. Requestors will be required to sign a Data Access Agreement.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lennart Edmark, Region Västmanland:
Venous admixture
Computed Tomography
Oxygenation test

Additional relevant MeSH terms:
Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases