Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation? - Full Text View

Purpose

The purpose of this study is to determine whether breathing high levels of oxygen during surgery affects oxygen levels after surgery. The second purpose of this study is to determine whether giving PEEP and high oxygen together affects your oxygen levels after surgery.

Condition	Intervention	Phase
Atelectasis	Procedure: compare this group to three remaining groups Procedure: assessment of need of postoperative oxygen Procedure: assessment of oxygen need	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Further study details as provided by University of Utah:

Primary Outcome Measures:

determining whether breathing high levels of oxygen during surgery affects oxygen levels after surgery [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group 1 will receive 30% oxygen plus PEEP	Procedure: compare this group to three remaining groups assess oxygen delivery and saturation, resp rate, characteristics of respirations
2: Active Comparator Group 2 will receive 30% oxygen without PEEP	Procedure: assessment of need of postoperative oxygen assess oxygen delivery and saturation, resp rate and respiratory characteristics
3: Active Comparator Group 3 will receive 90% oxygen plus PEEP	Procedure: assessment of oxygen need assess oxygen saturation and delivery with assessment of respiratory rate and characteristics
4: Active Comparator Group 4 will receive 90% oxygen and no PEEP	Procedure: assessment of oxygen need will monitor oxygen saturation and respiratory rate and characteristics

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18-70 years undergoing surgery under general endotracheal anesthesia at the University of Utah Hospital Operating Room and the Huntsman Cancer Hospital Operating room who will be admitted to the hospital for at least 24 hours after surgery

Exclusion Criteria:

Major (open) abdominal surgery
Major spine surgery
Craniotomy surgery
Surgeries where electrocautery or laser devices may be used near the airway (eg tracheostomy, oral surgery) because of the risk of fire with high inspired oxygen in these cases
Procedures planned for MAC or regional without general anesthesia
Planned airway management with a laryngeal mask airway rather than an endotracheal tube
Procedures planned in the prone position because this increases atelectasis
Planned postoperative intubation
Planned postoperative care in the intensive care unit
Recent (within 3 weeks) chemotherapy because of the increased risk of pulmonary oxygen toxicity
History of bleomycin administration because of the increased risk of pulmonary oxygen toxicity
Diagnosed Obstructive Sleep Apnea with home CPAP use
Home oxygen use
Preoperative RA SpO2 <90%
History of spontaneous pneumothorax
Emergency surgery
Pregnancy. Women of child-bearing age are routinely screened for pregnancy (urine HCG) on the morning of surgery. Patients with a positive result will be excluded from the study (and most likely will have their elective surgery cancelled).
Patient refusal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715741

Contacts


Contact: Julia L. White	801-587-4806	julia.white@hsc.utah.edu

Locations


United States, Utah
	University of Utah Health Sciences Center	Recruiting
	Salt Lake City, Utah, United States, 84132
	Contact: Julia L. White 801-587-4806 julia.white@hsc.utah.edu
	Principal Investigator: Harriet W. Hopf, MD

Sponsors and Collaborators

University of Utah

Investigators


Principal Investigator:	Harriet Hopf, M.D.	University of Utah

More Information

Responsible Party:	Department of Anesthesiology ( Harriet W. Hopf, M.D., Professor )
Study ID Numbers:	29830
First Received:	July 10, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00715741
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

atelectasis

oxygen

saturation

Study placed in the following topic categories:

Atelectasis

Respiratory Tract Diseases

Lung Diseases

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00715741