University of Utah Health Sciences Center
Salt Lake City, Utah, 84132, United States
NCT Number: NCT00715741
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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Notify Me18 year–70 year
All sexes
Interventional
Phase 2 / Phase 3
Salt Lake City, Utah, 84132, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates
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 names: O2, Dioxygen, Sats, Oxygen Saturation, Pulmonary ventilation rate, Ventilation rate, Breathing rates
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%.
Time frame: 24 hours after tracheal extubation
amount of oxygen (LPM) required to maintain SpO2 >90%
Time frame: 45 min after tracheal extubation
SpO2 measured on room air or minimum supplemental oxygen to keep SpO2>90%
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.
University of Utah
Other
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