Laparotomy Clinical Trial
Official title:
Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy
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 |
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.
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | The Danish Medical Research Council |
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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