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Oxygen Level and Safe Emergence From Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779076
First Posted: January 30, 2013
Last Update Posted: June 25, 2013
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.
Information provided by (Responsible Party):
Lennart Edmark, Landstinget Västmanland
  Purpose
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.

Condition Intervention
Focus of Study is Postoperative Pulmonary Atelectacis Procedure: 30% oxygen Procedure: 100% oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Lennart Edmark, Landstinget Västmanland:

Primary Outcome Measures:
  • Area of atelectasis [ Time Frame: 30 minutes ]
    The area of atelectasis is investigated by computed tomography of the lungs postoperatively


Secondary Outcome Measures:
  • Peripheral oxygen saturation (SpO2) [ Time Frame: 3 hours ]
    SpO2 is continuously assessed postoperatively.


Enrollment: 59
Study Start Date: February 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01779076


Locations
Sweden
Västmanlands sjukhus Köping
Köping, Västmanland, Sweden, 731 81
Sponsors and Collaborators
Region Västmanland
Investigators
Principal Investigator: Mats Enlund, M.D., Ph.D. Landstinget i Värmland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lennart Edmark, M.D., Landstinget Västmanland
ClinicalTrials.gov Identifier: NCT01779076     History of Changes
Other Study ID Numbers: Dnr 2012 / 539
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: June 25, 2013
Last Verified: June 2013