Back to resultsDoes High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Primary Purpose
Atelectasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water
FiO2 0.3 without PEEP
FiO2 >0.9 with 3-5 cm water PEEP
FiO2 >0.9 without PEEP
Sponsored by
About this trial
This is an interventional diagnostic trial for Atelectasis focused on measuring atelectasis, oxygen, saturation
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
Sites / Locations
- University of Utah Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery
Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery
Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery
Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery
Outcomes
Primary Outcome Measures
Oxygen Requirement to Maintain SpO2>90%
Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.
Oxygen Requirement
amount of oxygen (LPM) required to maintain SpO2 >90%
Secondary Outcome Measures
Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%
SpO2 Postoperatively
SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00715741
Brief Title
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Official Title
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
atelectasis, oxygen, saturation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery
Arm Title
2
Arm Type
Active Comparator
Arm Description
Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery
Arm Title
3
Arm Type
Active Comparator
Arm Description
Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery
Arm Title
4
Arm Type
Active Comparator
Arm Description
Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery
Intervention Type
Other
Intervention Name(s)
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water
Other Intervention Name(s)
O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates, positive end expiratory pressure
Intervention Description
FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water
Intervention Type
Other
Intervention Name(s)
FiO2 0.3 without PEEP
Other Intervention Name(s)
O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates
Intervention Description
FiO2 0.3 without PEEP
Intervention Type
Other
Intervention Name(s)
FiO2 >0.9 with 3-5 cm water PEEP
Other Intervention Name(s)
O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates, positive end expiratory pressure
Intervention Description
FiO2 >0.9 with 3-5 cm water PEEP
Intervention Type
Other
Intervention Name(s)
FiO2 >0.9 without PEEP
Other Intervention Name(s)
O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates
Intervention Description
FiO2 >0.9 without PEEP
Primary Outcome Measure Information:
Title
Oxygen Requirement to Maintain SpO2>90%
Description
Arterial oxygen saturation by pulse oximetry (SpO2) is measured while subject is lying quietly in the post anesthesia care unit (PACU) and breathing room air (RA). Oxygen is added 0.5 liters per min (LPM) at a time to maintain SpO2 >90%.
Time Frame
45 min after emergence (tracheal extubation)
Title
Oxygen Requirement
Description
amount of oxygen (LPM) required to maintain SpO2 >90%
Time Frame
24 hours after tracheal extubation
Secondary Outcome Measure Information:
Title
Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"
Description
SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%
Time Frame
45 min after tracheal extubation
Title
SpO2 Postoperatively
Description
SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.
Time Frame
24 hours after tracheal extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harriet Hopf, M.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12502973
Citation
Tusman G, Bohm SH, Tempra A, Melkun F, Garcia E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22. doi: 10.1097/00000542-200301000-00006.
Results Reference
background
PubMed Identifier
16249417
Citation
Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035. Erratum In: JAMA. 2005 Dec 21;294(23):2973.
Results Reference
background
PubMed Identifier
15791115
Citation
Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
Results Reference
background
PubMed Identifier
17667565
Citation
Myles PS, Leslie K, Chan MT, Forbes A, Paech MJ, Peyton P, Silbert BS, Pascoe E; ENIGMA Trial Group. Avoidance of nitrous oxide for patients undergoing major surgery: a randomized controlled trial. Anesthesiology. 2007 Aug;107(2):221-31. doi: 10.1097/01.anes.0000270723.30772.da.
Results Reference
background
Learn more about this trial
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
We'll reach out to this number within 24 hrs