Skip to main content
OpenTrials
Completed

NCT Number: NCT00637936

Respiratory Effects of Perioperative Oxygen During General Anaesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oxygen

Drug

Inspiratory fraction during anaesthesia

Primary outcomes

  1. Change in PaO2/FiO2-index during general anaesthesia.

    Time frame: End of surgery.

Secondary outcomes

  1. Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery.

    Time frame: 1½ hour after surgery.

  2. Atelectasis and Pneumonia

    Time frame: 14 days after surgery

  3. Arterial oxygen saturation

    Time frame: 2 hours and 3 days after surgery.

  4. Change in functional residual capacity (FRC)

    Time frame: 2 hours after surgery.

  5. Change in effective pulmonary bloodflow

    Time frame: 2 hours after surgery.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 18, 2008
Registry last updated
Jan 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.