Clinical trial NCT00637936: Respiratory Effects of Perioperative Oxygen During General Anaesthesia
Official title: Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparotomy
Keywords: perioperative oxygen
respiratory complications
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2008-03-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in PaO2/FiO2-index during general anaesthesia.
timeFrame: End of surgery.
Secondary outcomes:
measure: Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery.
timeFrame: 1½ hour after surgery.
measure: Atelectasis and Pneumonia
timeFrame: 14 days after surgery
measure: Arterial oxygen saturation
timeFrame: 2 hours and 3 days after surgery.
measure: Change in functional residual capacity (FRC)
timeFrame: 2 hours after surgery.
measure: Change in effective pulmonary bloodflow
timeFrame: 2 hours after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Christian S Meyhoff, MD
role: STUDY_DIRECTOR
affiliation: Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Lars S Rasmussen, MD, PHD, DMSC
role: STUDY_CHAIR
affiliation: Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Steen Henneberg, MD,DMSC
role: STUDY_DIRECTOR
affiliation: Detp. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
name: Anne Kathrine Stæhr
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark
name: Poul L Christensen, MD
role: STUDY_DIRECTOR
References:
citation: Staehr AK, Meyhoff CS, Henneberg SW, Christensen PL, Rasmussen LS. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial. BMC Res Notes. 2012 Jul 28;5:383. doi: 10.1186/1756-0500-5-383.