Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00715741
First received: July 10, 2008
Last updated: February 2, 2010
Last verified: February 2010

July 10, 2008
February 2, 2010
June 2008
July 2009   (final data collection date for primary outcome measure)
  • Oxygen Requirement to Maintain SpO2>90% [ Time Frame: 45 min after emergence (tracheal extubation) ] [ Designated as safety issue: Yes ]
  • Oxygen Requirement [ Time Frame: 24 hours after tracheal extubation ] [ Designated as safety issue: Yes ]
determining whether breathing high levels of oxygen during surgery affects oxygen levels after surgery [ Time Frame: postoperative ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00715741 on ClinicalTrials.gov Archive Site
  • Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)" [ Time Frame: 45 min after tracheal extubation ] [ Designated as safety issue: Yes ]
  • SpO2 Postoperatively [ Time Frame: 24 hours after tracheal extubation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Atelectasis
  • 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
    Other Names:
    • O2
    • Dioxygen
    • Sats
    • Oxygen Saturation
    • Pulmonary ventilation rate
    • Ventilation rate
    • Breathing rates
    • positive end expiratory pressure
  • Other: FiO2 0.3 without PEEP
    FiO2 0.3 without PEEP
    Other Names:
    • O2
    • Dioxygen
    • Sats
    • Oxygen Saturation
    • Pulmonary ventilation rate
    • Ventilation rate
    • Breathing rates
  • Other: FiO2 >0.9 with 3-5 cm water PEEP
    FiO2 >0.9 with 3-5 cm water PEEP
    Other Names:
    • O2
    • Dioxygen
    • Sats
    • Oxygen Saturation
    • Pulmonary ventilation rate
    • Ventilation rate
    • Breathing rates
    • positive end expiratory pressure
  • Other: FiO2 >0.9 without PEEP
    FiO2 >0.9 without PEEP
    Other Names:
    • O2
    • Dioxygen
    • Sats
    • Oxygen Saturation
    • Pulmonary ventilation rate
    • Ventilation rate
    • Breathing rates
  • Active Comparator: 1
    Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery
    Intervention: Other: FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water
  • Active Comparator: 2
    Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery
    Intervention: Other: FiO2 0.3 without PEEP
  • Active Comparator: 3
    Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery
    Intervention: Other: FiO2 >0.9 with 3-5 cm water PEEP
  • Active Comparator: 4
    Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery
    Intervention: Other: FiO2 >0.9 without PEEP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00715741
29830
No
Harriet W. Hopf, M.D., Professor, Department of Anesthesiology
University of Utah
Not Provided
Principal Investigator: Harriet Hopf, M.D. University of Utah
University of Utah
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP