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Respiratory Effects of Perioperative Oxygen During General Anaesthesia

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University of Copenhagen

Status and phase

Completed
Phase 4

Conditions

Laparotomy

Treatments

Drug: Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT00637936
KF 02 306766-B

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

35 participants in 2 patient groups

1
Active Comparator group
Description:
Group 1 is given 30% oxygen during and 2 hours after surgery
Treatment:
Drug: Oxygen
2
Active Comparator group
Description:
Group 2 is given 80% during and 2 hours after surgery.
Treatment:
Drug: Oxygen

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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