NCT03352336

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

November 19, 2017

Last Update Submit

October 11, 2018

Conditions

AtelectasisOxygenation

Keywords

AtelectasisOxygenationVenous admixtureComputed TomographyOxygenation test

Outcome Measures

Primary Outcomes (1)

  • Atelectasis area

    Atelectasis area as studied by computed tomography

    30 min after emergence from anesthesia

Secondary Outcomes (1)

  • Pulmonary shunt estimated by a standardised oxygenation test

    30 min after emergence from anesthesia

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients fulfilling inclusion and exclusion criteria while attending the day case department of Köping county hospital in Region Västmanland.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Västmanlands sjukhus Köping

Köping, Västmanland County, 73181, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Arterial blood gases

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Lennart Edmark, M.D., Ph.D.

    Region Västmanland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2017

First Posted

November 24, 2017

Study Start

December 4, 2017

Primary Completion

August 28, 2018

Study Completion

August 28, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome will be available.

Shared Documents
STUDY PROTOCOL, 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.

Locations

SE(1)