Respiratory Effects of Perioperative Oxygen During General Anaesthesia

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00637936

Collaborator

The Danish Medical Research Council (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Laparotomy	Drug: Oxygen	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Group 1 is given 30% oxygen during and 2 hours after surgery	Drug: Oxygen Inspiratory fraction during anaesthesia
Active Comparator: 2 Group 2 is given 80% during and 2 hours after surgery.	Drug: Oxygen Inspiratory fraction during anaesthesia

Arm

Intervention/Treatment

Active Comparator: 1

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

Drug: Oxygen

Inspiratory fraction during anaesthesia

Active Comparator: 2

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

Drug: Oxygen

Inspiratory fraction during anaesthesia

Outcome Measures

Primary Outcome Measures

Change in PaO2/FiO2-index during general anaesthesia. [End of surgery.]

Secondary Outcome Measures

Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery. [1½ hour after surgery.]
Atelectasis and Pneumonia [14 days after surgery]
Arterial oxygen saturation [2 hours and 3 days after surgery.]
Change in functional residual capacity (FRC) [2 hours after surgery.]
Change in effective pulmonary bloodflow [2 hours after surgery.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Copenhagen
The Danish Medical Research Council

Investigators

Study Director: Christian S Meyhoff, MD, Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Chair: Lars S Rasmussen, MD, PHD, DMSC, Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Steen Henneberg, MD,DMSC, Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Anne Kathrine Stæhr, Detp. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Poul L Christensen, MD, Dept. of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00637936

Other Study ID Numbers:

KF 02 306766-B

First Posted:

Mar 18, 2008

Last Update Posted:

Jan 12, 2009

Last Verified:

Jan 1, 2009

Keywords provided by , ,

perioperative oxygen

respiratory complications

Study Results

No Results Posted as of Jan 12, 2009