Respiratory Effects of Perioperative Oxygen During General Anaesthesia

January 9, 2009 updated by: University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in PaO2/FiO2-index during general anaesthesia.
Time Frame: End of surgery.
End of surgery.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KF 02 306766-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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