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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Group 1 will receive 30% oxygen plus PEEP + 3 to 5 cm Water duration of anesthesia and surgery |
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| 2 | Active Comparator | Group 2 will receive 30% oxygen without PEEP for the duration of anesthesia and surgery |
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| 3 | Active Comparator | Group 3 will receive > 90% oxygen plus PEEP + 3 to 5 cm of water for the duration of anesthesia and surgery |
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| 4 | Active Comparator | Group 4 will receive > 90% oxygen and no PEEP for the duration of anesthesia and surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3 -5 cm water | Other | FiO2 (fraction of inspired oxygen) 0.3 plus PEEP (positive end expiratory pressure) 3-5 cm water |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 45 min after emergence (tracheal extubation) |
| Oxygen Requirement | amount of oxygen (LPM) required to maintain SpO2 >90% | 24 hours after tracheal extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)" | SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90% | 45 min after tracheal extubation |
| SpO2 Postoperatively | SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harriet Hopf, M.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12502973 | Background | 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. | |
| 16249417 | Background | 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. |
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Recruitment started 06/24/2008 and ended 07/07/2009. Subjects were recruited via the Operating room schedule
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| ID | Title | Description |
|---|---|---|
| FG000 | Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP | 30% oxygen with positive end expiratory pressure (PEEP) |
| FG001 | Fi02 0.3 Without PEEP | 30% oxygen without PEEP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FiO2 0.3 without PEEP | Other | FiO2 0.3 without PEEP |
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| FiO2 >0.9 with 3-5 cm water PEEP | Other | FiO2 >0.9 with 3-5 cm water PEEP |
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| FiO2 >0.9 without PEEP | Other | FiO2 >0.9 without PEEP |
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| 24 hours after tracheal extubation |
| 15791115 | Background | Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021. |
| 17667565 | Background | 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. |
| FG002 | Fi02 0.9 With PEEP | 90% oxygen plus PEEP |
| FG003 | Fi02 0.9 Without PEEP | 90% oxygen without PEEP |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP | 30% oxygen with positive end expiratory pressure (PEEP) |
| BG001 | Fi02 0.3 Without PEEP | 30% oxygen without PEEP |
| BG002 | Fi02 0.9 With PEEP | 90% oxygen plus PEEP |
| BG003 | Fi02 0.9 Without PEEP | 90% oxygen without PEEP |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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%. | Posted | Jul 2009 | Median | Inter-Quartile Range | liters per minute | 45 min after emergence (tracheal extubation) |
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| Primary | Oxygen Requirement | amount of oxygen (LPM) required to maintain SpO2 >90% | Posted | Jul 2009 | Median | Inter-Quartile Range | liters per min | 24 hours after tracheal extubation |
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| Secondary | Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)" | SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90% | Posted | Jul 2009 | Mean | Standard Deviation | percent saturation | 45 min after tracheal extubation |
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| Secondary | SpO2 Postoperatively | SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation. | Posted | Jul 2009 | Mean | Standard Deviation | percent saturation | 24 hours after tracheal extubation |
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1 year
No serious and/or non-serious adverse events were observed or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fi02 (Fraction of Inspired Oxygen) 0.3 With PEEP | 30% oxygen with positive end expiratory pressure (PEEP) | 0 | 25 | 0 | 25 | ||
| EG001 | Fi02 0.3 Without PEEP | 30% oxygen without PEEP | 0 | 25 | 0 | 25 | ||
| EG002 | Fi02 0.9 With PEEP | 90% oxygen plus PEEP | 0 | 25 | 0 | 25 | ||
| EG003 | Fi02 0.9 Without PEEP | 90% oxygen without PEEP | 0 | 25 | 0 | 25 |
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This data for this outcome measure is identical
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harriet Hopf, MD | University of Utah | 801-205-1013 | Harriet.Hopf@hsc.utah.edu |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D014867 | Water |
| D010100 | Oxygen |
| D000089382 | Oxygen Saturation |
| D056152 | Respiratory Rate |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |
| D005740 | Gases |
| D008660 | Metabolism |
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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