Oxygen Level and Safe Emergence From Anesthesia
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.
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2013
CompletedJanuary 17, 2018
January 1, 2018
4 months
January 28, 2013
January 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Area of atelectasis
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
30 minutes
Secondary Outcomes (1)
Peripheral oxygen saturation (SpO2)
3 hours
Study Arms (2)
100% oxygen during extubation
EXPERIMENTALIn this arm the intervention will consist of 100 % oxygen.
30% oxygen during extubation
EXPERIMENTALIn this arm the intervention will consist of 30 % oxygen.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Västmanlands sjukhus Köping
Köping, Västmanland County, 731 81, Sweden
Related Publications (1)
Edmark L, Auner U, Lindback J, Enlund M, Hedenstierna G. Post-operative atelectasis - a randomised trial investigating a ventilatory strategy and low oxygen fraction during recovery. Acta Anaesthesiol Scand. 2014 Jul;58(6):681-8. doi: 10.1111/aas.12322. Epub 2014 Apr 11.
PMID: 24720763DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mats Enlund, M.D., Ph.D.
Landstinget i Värmland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
January 28, 2013
First Posted
January 30, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 11, 2013
Last Updated
January 17, 2018
Record last verified: 2018-01