Estimation of Perioperative Atelectasis

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Sweden
  • Västmanland
    • Köping, Västmanland, Sweden, 73181
      • Västmanlands sjukhus Köping

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atelectasis area	Atelectasis area as studied by computed tomography	30 min after emergence from anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary shunt estimated by a standardised oxygenation test	Pulmonary shunt estimated by a standardised oxygenation test using	30 min after emergence from anesthesia

Collaborators and Investigators

• Sponsor: Region Västmanland
• Investigators: Study Director: Lennart Edmark, M.D., Ph.D., Region Västmanland

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Computed Tomography; Atelectasis; Oxygenation; Venous admixture; Oxygenation test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: Dnr 2017/27:2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome will be available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No