Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Atelectasis Clinical Trial

Official title:

Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715741
• Other study ID #: 29830
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 10, 2008
• Last updated: February 2, 2010
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

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
• FiO2 0.3 without PEEP
FiO2 0.3 without PEEP
• FiO2 >0.9 with 3-5 cm water PEEP
FiO2 >0.9 with 3-5 cm water PEEP
• FiO2 >0.9 without PEEP
FiO2 >0.9 without PEEP

Locations

Country	Name	City	State
United States	University of Utah Health Sciences Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (4)

Belda FJ, Aguilera L, García de la Asunción J, Alberti J, Vicente R, Ferrándiz L, Rodríguez R, Company R, Sessler DI, Aguilar G, Botello SG, Ortí 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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Requirement to Maintain SpO2>90%		45 min after emergence (tracheal extubation)	Yes
Primary	Oxygen Requirement		24 hours after tracheal extubation	Yes
Secondary	Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"		45 min after tracheal extubation	Yes
Secondary	SpO2 Postoperatively		24 hours after tracheal extubation	Yes