Respiratory Effects of Perioperative Oxygen During General Anaesthesia

NCT ID: NCT00637936

Last Updated: 2009-01-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery.

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.

Detailed Description

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Conditions

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Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group 1 is given 30% oxygen during and 2 hours after surgery

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Inspiratory fraction during anaesthesia

2

Group 2 is given 80% during and 2 hours after surgery.

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

Inspiratory fraction during anaesthesia

Interventions

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Oxygen

Inspiratory fraction during anaesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Laparatomy, elective

Exclusion Criteria

* Inability to give informed consent
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Danish Medical Research Council

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

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.

Reference Type DERIVED
PMID: 22840231 (View on PubMed)

Other Identifiers

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KF 02 306766-B

Identifier Type: -

Identifier Source: org_study_id

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