Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation? - Full Text View

Purpose

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.

Condition	Intervention	Phase
Atelectasis	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	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water Oxygen Therapy

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	100
Study Start Date:	June 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 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 Other Names: O2 Dioxygen Sats Oxygen Saturation Pulmonary ventilation rate Ventilation rate Breathing rates positive end expiratory pressure
Active Comparator: 2 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 Other Names: O2 Dioxygen Sats Oxygen Saturation Pulmonary ventilation rate Ventilation rate Breathing rates
Active Comparator: 3 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 Other Names: O2 Dioxygen Sats Oxygen Saturation Pulmonary ventilation rate Ventilation rate Breathing rates positive end expiratory pressure
Active Comparator: 4 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 Other Names: O2 Dioxygen Sats Oxygen Saturation Pulmonary ventilation rate Ventilation rate Breathing rates

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715741

Locations

United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Harriet Hopf, M.D.

University of Utah

More Information

Publications:

Tusman G, Böhm SH, Tempra A, Melkun F, García E, Turchetto E, Mulder PG, Lachmann B. Effects of recruitment maneuver on atelectasis in anesthetized children. Anesthesiology. 2003 Jan;98(1):14-22.

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. Erratum in: JAMA. 2005 Dec 21;294(23):2973.

Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. Review.

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.

Responsible Party:	Harriet W. Hopf, M.D., Professor, Department of Anesthesiology
ClinicalTrials.gov Identifier:	NCT00715741 History of Changes
Other Study ID Numbers:	29830
Study First Received:	July 10, 2008
Results First Received:	August 11, 2009
Last Updated:	February 2, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

atelectasis
oxygen
saturation

Additional relevant MeSH terms:

Pulmonary Atelectasis
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013