Respiratory Effects of Perioperative Oxygen During General Anaesthesia

Phase 4

Completed

• Conditions: Laparotomy
• Interventions: Drug: Oxygen

• Registration Number: NCT00637936
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-18
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-09
• Last Update Posted: 2009-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Oxygen	Group 2 is given 80% during and 2 hours after surgery.
1	Oxygen	Group 1 is given 30% oxygen during and 2 hours after surgery

Primary Outcome Measures

Name	Time	Method
Change in PaO2/FiO2-index during general anaesthesia.	End of surgery.

Secondary Outcome Measures

Name	Time	Method
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.