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.

Study Overview

• Status: Completed
• Conditions: Atelectasis
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	24 hours after tracheal extubation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Duggan M, Kavanagh BP. Pulmonary atelectasis: a pathogenic perioperative entity. Anesthesiology. 2005 Apr;102(4):838-54. doi: 10.1097/00000542-200504000-00021.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (Estimate): July 15, 2008

Study Record Updates

• Last Update Posted (Estimate): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: atelectasis; oxygen; saturation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: 29830