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Respiratory Effects of Perioperative Oxygen During General Anaesthesia

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ClinicalTrials.gov Identifier: NCT00637936
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : January 12, 2009
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
University of Copenhagen

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 Type : Interventional  (Clinical Trial)
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 : March 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. Change in PaO2/FiO2-index during general anaesthesia. [ Time Frame: End of surgery. ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 18, 2008    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009

Keywords provided by University of Copenhagen:
perioperative oxygen
respiratory complications