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Clinical Trials/NCT00637936
NCT00637936
Completed
Phase 4

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

University of Copenhagen0 sites35 target enrollmentMarch 2008
ConditionsLaparotomy
InterventionsOxygen
DrugsOxygen

Overview

Phase
Phase 4
Intervention
Oxygen
Conditions
Laparotomy
Sponsor
University of Copenhagen
Enrollment
35
Primary Endpoint
Change in PaO2/FiO2-index during general anaesthesia.
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
August 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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)

Arms & Interventions

1

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

Intervention: Oxygen

2

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

Intervention: Oxygen

Outcomes

Primary Outcomes

Change in PaO2/FiO2-index during general anaesthesia.

Time Frame: End of surgery.

Secondary Outcomes

  • 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.)

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