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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00637936
Other study ID # KF 02 306766-B
Secondary ID
Status Completed
Phase Phase 4
First received March 10, 2008
Last updated January 9, 2009
Start date March 2008
Est. completion date August 2008

Study information

Verified date January 2009
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Oxygen
Inspiratory fraction during anaesthesia

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Copenhagen The Danish Medical Research Council

Outcome

Type Measure Description Time frame Safety issue
Primary Change in PaO2/FiO2-index during general anaesthesia. End of surgery. No
Secondary Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery. 1½ hour after surgery. No
Secondary Atelectasis and Pneumonia 14 days after surgery No
Secondary Arterial oxygen saturation 2 hours and 3 days after surgery. No
Secondary Change in functional residual capacity (FRC) 2 hours after surgery. No
Secondary Change in effective pulmonary bloodflow 2 hours after surgery. No
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