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Oxygen Level and Safe Emergence From Anesthesia

This study is currently recruiting participants.
Verified April 2013 by Landstinget Västmanland
Sponsor:
Information provided by (Responsible Party):
Lennart Edmark, Landstinget Västmanland
ClinicalTrials.gov Identifier:
NCT01779076
First received: January 28, 2013
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Landstinget Västmanland:

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


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


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779076

Contacts
Contact: Lennart Edmark, M.D. 21 173000 ext 046 lennart.edmark@ltv.se

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

No publications provided

Responsible Party: Lennart Edmark, M.D., Landstinget Västmanland
ClinicalTrials.gov Identifier: NCT01779076     History of Changes
Other Study ID Numbers: Dnr 2012 / 539
Study First Received: January 28, 2013
Last Updated: April 25, 2013
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013