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Respiratory Effects of Perioperative Oxygen During General Anaesthesia

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00637936
First received: March 10, 2008
Last updated: January 9, 2009
Last verified: January 2009
History of Changes
  Purpose

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 Intervention Phase
Laparotomy
 Drug: Oxygen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Change in PaO2/FiO2-index during general anaesthesia. [ Time Frame: End of surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery. [ Time Frame: 1½ hour after surgery. ] [ Designated as safety issue: No ]
  • Atelectasis and Pneumonia [ Time Frame: 14 days after surgery ] [ Designated as safety issue: No ]
  • Arterial oxygen saturation [ Time Frame: 2 hours and 3 days after surgery. ] [ Designated as safety issue: No ]
  • Change in functional residual capacity (FRC) [ Time Frame: 2 hours after surgery. ] [ Designated as safety issue: No ]
  • Change in effective pulmonary bloodflow [ Time Frame: 2 hours after surgery. ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637936

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
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lars S Rasmussen, Dept.of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00637936     History of Changes
Other Study ID Numbers: KF 02 306766-B
Study First Received: March 10, 2008
Last Updated: January 9, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by University of Copenhagen:
perioperative oxygen
respiratory complications

ClinicalTrials.gov processed this record on May 23, 2013