Oxygen Level and Safe Emergence From Anesthesia

January 14, 2018 updated by: Lennart Edmark, Region Västmanland

Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.

Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västmanland
      • Köping, Västmanland, Sweden, 731 81
        • Västmanlands sjukhus Köping

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No sign of difficult airway or intubation
  • Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
  • Body mass index less than 35.
  • American Society of Anesthesiologists physical status (ASA) class I-III

Exclusion Criteria:

  • Body mass index 35 or higher
  • Increased risk of aspiration
  • Obstructive sleep apnea syndrome
  • Procedures during surgery making a former easy airway a difficult airway
  • Need for opioids after extubation
  • Hypothermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 100% oxygen during extubation
In this arm the intervention will consist of 100 % oxygen.
Procedure: 100% oxygen
EXPERIMENTAL: 30% oxygen during extubation
In this arm the intervention will consist of 30 % oxygen.
Procedure: 30% oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of atelectasis
Time Frame: 30 minutes
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral oxygen saturation (SpO2)
Time Frame: 3 hours
SpO2 is continuously assessed postoperatively.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Västmanland

Investigators

  • Principal Investigator: Mats Enlund, M.D., Ph.D., Landstinget i Värmland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 11, 2013

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (ESTIMATE)

January 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2018

Last Update Submitted That Met QC Criteria

January 14, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Dnr 2012 / 539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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