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Completed

NCT Number: NCT00715741

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates, positive end expiratory pressure

FiO2 0.3 without PEEP

Other

FiO2 0.3 without PEEP

Other names: O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates

FiO2 >0.9 with 3-5 cm water PEEP

Other

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

FiO2 >0.9 without PEEP

Other

FiO2 >0.9 without PEEP

Other names: O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates

Primary outcomes

  1. Oxygen Requirement to Maintain SpO2>90%

    Time frame: 45 min after emergence (tracheal extubation)

    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%.

  2. Oxygen Requirement

    Time frame: 24 hours after tracheal extubation

    amount of oxygen (LPM) required to maintain SpO2 >90%

Secondary outcomes

  1. Arterial Oxygen Saturation by Pulse Oximetry "(SpO2)"

    Time frame: 45 min after tracheal extubation

    SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%

  2. SpO2 Postoperatively

    Time frame: 24 hours after tracheal extubation

    SpO2 is measured on room air or minimum oxygen required to keep SpO2>90% on the ward 24 hours after tracheal extubation.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2008
Registry last updated
Feb 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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