Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Overview:

Status: Completed
Study State Date: June 2008
Primary Completion Date: Actual July 2009
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Phase: Phase 2/Phase 3

Sponsor(s):

University of Utah

Information By: University of Utah
Trial Identifier: NCT00715741
Official Title: Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Description: 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.

+ Additional Objectives Detail

This is a randomized, controlled, blinded trial in patients undergoing non-abdominal surgery of the effect of intraoperative increased inspired oxygen used (FiO2>0.9 vs. FiO2 = 0.3) on non-invasive oxygen saturation (pulse oximetry, SpO2) and amount of required supplemental oxygen in the post-anesthesia care unit (PACU); arterial oxygen partial pressure (PaO2) after 45 minutes in the PACU; room air SpO2 24 hours after surgery, and amount of supplemental oxygen required 24 hours after surgery. The purpose of the study is to determine whether absorption atelectasis induced by use of inspired oxygen concentrations in excess of 90% leads to a higher risk of hypoxemia, as evidenced by room air oxygen values and the need for supplemental oxygen. The objective of this study is to determine whether high inspired oxygen (>0.8), which has been demonstrated to reduce the risk of surgical site infection in patients undergoing colon surgery and other major surgical procedures has side effects that limit its use to prevent infection in lower risk operations. There are four groups of intraoperative ventilation management in this study. Fi02 0.3 plus PEEP, Fi02 0.3 without PEEP, Fi02 greater than 0.9 plus PEEP 3 to 5 cm of water, Fi02 greater than 0.9 without PEEP.

Eligibility:

Accepts Healthy Volunteers?: No
Enrollment: 100 Actual
Minimum Age: 18 Years
Maximum Age: 70 Years
Gender(s): Both
Additional 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

Conditions:
Atelectasis

Interventions:
Other: 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

Primary Outcome Measures:

Oxygen Requirement to Maintain SpO2>90%
Time Frame: 45 min after emergence (tracheal extubation)
Safety Issue: Yes

Oxygen Requirement
Time Frame: 24 hours after tracheal extubation
Safety Issue: Yes

Secondary Outcome Measures:

Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
Time Frame: 45 min after tracheal extubation
Safety Issue: Yes

SpO2 Postoperatively
Time Frame: 24 hours after tracheal extubation
Safety Issue: Yes

Patient Groups:

Assigned Interventions:

1: Active Comparator
Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery

Other: FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water

2: Active Comparator
Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery

Other: FiO2 0.3 without PEEP
FiO2 0.3 without PEEP

3: Active Comparator
Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery

Other: FiO2 >0.9 with 3-5 cm water PEEP
FiO2 >0.9 with 3-5 cm water PEEP

4: Active Comparator
Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery

Other: FiO2 >0.9 without PEEP
FiO2 >0.9 without PEEP

Location & Contacts:

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

Responsible Party:
Department of Anesthesiology (Harriet W. Hopf, M.D., Professor)

Study Locations:
+ Show All 1 Study Locations

United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States

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