Respiratory Effects of Perioperative Oxygen During General Anaesthesia

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00637936

Enrollment

Registered

2008-03-18

Start date

2008-03-31

Completion date

2008-08-31

Last updated

2009-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparotomy

Keywords

perioperative oxygen, respiratory complications

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.

Interventions

DRUGOxygen

Inspiratory fraction during anaesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change in PaO2/FiO2-index during general anaesthesia.	End of surgery.

Secondary

Measure	Time frame
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026