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Oxygen Level and Safe Emergence From Anesthesia

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ClinicalTrials.gov Identifier: NCT01779076
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Lennart Edmark, Region Västmanland

Brief Summary:
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 or disease Intervention/treatment Phase
Focus of Study is Postoperative Pulmonary Atelectacis Procedure: 30% oxygen Procedure: 100% oxygen Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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.
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 11, 2013

Resource links provided by the National Library of Medicine


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



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


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



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lennart Edmark, M.D., Region Västmanland
ClinicalTrials.gov Identifier: NCT01779076     History of Changes
Other Study ID Numbers: Dnr 2012 / 539
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018