Phase 3
N=100
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT00715741 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcome: Primary: Oxygen Requirement to Maintain SpO2>90% — 1; 1; 1; 1 liters per minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water (Other); FiO2 0.3 without PEEP (Other); FiO2 >0.9 with 3-5 cm water PEEP (Other); FiO2 >0.9 without PEEP (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Requirement to Maintain SpO2>90% |
1; 1; 1; 1 | — |
| PRIMARY Oxygen Requirement |
0.5; 0.5; 1.0; 0.5 | — |
| SECONDARY Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)" |
95; 96; 95; 95 | — |
| SECONDARY SpO2 Postoperatively |
95; 95; 95; 95 | — |
Summary
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 positive end expiratory pressure PEEP and high oxygen together affects patients oxygen levels after surgery.
Eligibility 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 monitored anesthesia care (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 continuous pulmonary airway pressure (CPAP) use
- Home oxygen use
- Preoperative room air (RA) SpO2 <90%
- History of spontaneous pneumothorax
- Emergency surgery
- Pregnancy. Women of child-bearing age are routinely screened for pregnancy urine human chorionic gonadotropin, (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
Data sourced from ClinicalTrials.gov (NCT00715741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.