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NCT03352336 Clinical Trial

Estimation of Perioperative Atelectasis

Atelectasis Clinical Trial

Official title:
A Comparison Between Two Methods for Estimating the Extent of Perioperative Atelectasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03352336
Other study ID # Dnr 2017/27:2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 4, 2017
Est. completion date August 28, 2018

Study information
Verified date October 2018
Source Region Västmanland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 28, 2018
Est. primary completion date August 28, 2018
Accepts healthy volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Västmanlands sjukhus Köping Köping Västmanland

Sponsors (1)
Lead Sponsor Collaborator
Region Västmanland

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Atelectasis area Atelectasis area as studied by computed tomography 30 min after emergence from anesthesia
Secondary Pulmonary shunt estimated by a standardised oxygenation test Pulmonary shunt estimated by a standardised oxygenation test using 30 min after emergence from anesthesia
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