Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2013-08-31
2013-11-30
Brief Summary
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Detailed Description
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Previous studies have shown that formation of atelectasis during preoxygenation and induction of anesthesia can be avoided by adding a continuous positive airway pressure (CPAP) followed by a positive end-expiratory pressure (PEEP).During emergence from anesthesia, high concentrations of oxygen predispose to atelectasis formation. Even a recruitment maneuver, followed by ventilation with 100% oxygen with a PEEP/CPAP of 10 cm H2O until extubation, failed to improve postoperative oxygenation compared with that achieved with zero end-expiratory pressure (ZEEP).This failure may have been caused by the presence of lung regions with high oxygen concentrations.
The investigators hypothesized that by inducing and discontinuing anesthesia during CPAP/PEEP and deliberately reducing FIO2 after extubation, postoperative atelectasis would be reduced compared with standard protocols. To test our hypothesis, the investigators studied 1) a control group with no CPAP/PEEP and a FIO2 of 1.0 while breathing spontaneously after extubation, and 2) an intervention group that was on CPAP/PEEP of 6 cmH2O from induction to extubation and that received an FIO2 of 1.0 until extubation and then an FIO2 of 0.3 via a facemask while on CPAP after extubation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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No CPAP/PEEP and 100 % oxygen
This is the control group
No CPAP/PEEP and 100 % oxygen
This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
CPAP/PEEP and 30 % oxygen
This is the intervention group
CPAP/PEEP and 30 % oxygen
During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.
Interventions
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No CPAP/PEEP and 100 % oxygen
This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
CPAP/PEEP and 30 % oxygen
During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists (ASA) physical status class I-III.
3. Be able to climb two flight of stairs without stopping.
4. SpO2 of ≥ 94% when breathing air in the supine position.
5. A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of \< 31.
Exclusion Criteria
2. Smokers.
3. Ex smokers if smoked more than 5 pack years.
4. Overt heart failure
5. Known or predicted difficult intubation.
20 Years
75 Years
ALL
No
Sponsors
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Region Västmanland
OTHER
Responsible Party
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Lennart Edmark
M.D.
Principal Investigators
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Lennart Edmark, Md
Role: PRINCIPAL_INVESTIGATOR
Landstinget Vastmaland
Locations
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Västmanlands sjukhus Köping
Köping, Västmanland County, Sweden
Countries
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Other Identifiers
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Dnr 2008 / 251
Identifier Type: -
Identifier Source: org_study_id
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