Respiratory Effects of Perioperative Oxygen During General Anaesthesia

Laparotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637936
• Other study ID #: KF 02 306766-B
• 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

• Laparotomy

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