Respiratory Effects of Perioperative Oxygen During General Anaesthesia

NCT00637936 | Completed Phase 4

• 1 other identifier: KF 02 306766-B
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Laparotomy

Keywords

perioperative oxygen; respiratory complications

Outcome Measures

Primary Outcomes (1)

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

  End of surgery.

Secondary Outcomes (5)

• 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.

Study Arms (2)

1

ACTIVE COMPARATOR

Group 1 is given 30% oxygen during and 2 hours after surgery

Drug: Oxygen

2

ACTIVE COMPARATOR

Group 2 is given 80% during and 2 hours after surgery.

Drug: Oxygen

Interventions

Oxygen DRUG

Inspiratory fraction during anaesthesia

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Laparatomy, elective

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Copenhagen: lead
• The Danish Medical Research Council: collaborator

Related Publications (1)

• 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.

  PMID: 22840231 DERIVED

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Christian S Meyhoff, MD

  Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  STUDY DIRECTOR

• Lars S Rasmussen, MD, PHD, DMSC

  Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  STUDY CHAIR

• Steen Henneberg, MD,DMSC

  Dept.of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  STUDY DIRECTOR

• Anne Kathrine Stæhr

  Detp. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Poul L Christensen, MD

  Dept. of Anaesthesia and Intensive Care, Copenhagen University Hospital, Bispebjerg Hospital, Copenhagen, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 12, 2009

Record last verified: 2009-01