Respiratory Effects of Perioperative Oxygen During General Anaesthesia
NCT ID: NCT00637936
Last Updated: 2009-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
35 participants
INTERVENTIONAL
2008-03-31
2008-08-31
Brief Summary
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Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration.
Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
Group 1 is given 30% oxygen during and 2 hours after surgery
Oxygen
Inspiratory fraction during anaesthesia
2
Group 2 is given 80% during and 2 hours after surgery.
Oxygen
Inspiratory fraction during anaesthesia
Interventions
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Oxygen
Inspiratory fraction during anaesthesia
Eligibility Criteria
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Inclusion Criteria
* Laparatomy, elective
Exclusion Criteria
* Chemotherapy within 3 months
* Other surgery within 30 days(except surgery in local anaesthesia)
* Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)
18 Years
ALL
No
Sponsors
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The Danish Medical Research Council
OTHER
University of Copenhagen
OTHER
Responsible Party
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Dept.of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Principal Investigators
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Christian S Meyhoff, MD
Role: STUDY_DIRECTOR
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Lars S Rasmussen, MD, PHD, DMSC
Role: STUDY_CHAIR
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Steen Henneberg, MD,DMSC
Role: STUDY_DIRECTOR
Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Anne Kathrine Stæhr
Role: PRINCIPAL_INVESTIGATOR
Detp. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Poul L Christensen, MD
Role: STUDY_DIRECTOR
Dept. of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark
References
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Staehr AK, Meyhoff CS, Henneberg SW, Christensen PL, Rasmussen LS. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial. BMC Res Notes. 2012 Jul 28;5:383. doi: 10.1186/1756-0500-5-383.
Other Identifiers
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KF 02 306766-B
Identifier Type: -
Identifier Source: org_study_id
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