Ventilation Strategy Reduces Postoperative Atelectasis
Reduction in Postoperative Atelectasis by Continuous Positive Airway Pressure and Low Oxygen Concentration After Endotracheal Extubation.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Atelectasis is common during and after general anesthesia. The investigators hypothesized that a ventilation strategy with a combination of 1) continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) and 2) a reduced end-expiratory oxygen fraction (FETO2) before commencing mask ventilation with CPAP after extubation would reduce the area of postoperative atelectasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedAugust 26, 2014
August 1, 2014
3 months
July 26, 2013
August 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Area of atelectasis
The area of atelectasis is investigated by computed tomography of the lungs postoperatively
30 minutes
Secondary Outcomes (1)
Peripheral oxygen saturation (SpO2)
2 hours
Study Arms (2)
No CPAP/PEEP and 100 % oxygen
ACTIVE COMPARATORThis is the control group
CPAP/PEEP and 30 % oxygen
EXPERIMENTALThis is the intervention group
Interventions
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.
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
You may qualify if:
- Adult patients up to 75 years of age.
- American Society of Anesthesiologists (ASA) physical status class I-III.
- Be able to climb two flight of stairs without stopping.
- SpO2 of ≥ 94% when breathing air in the supine position.
- A body mass index (BMI, weight in kilograms divided by the square of the height in meters) of \< 31.
You may not qualify if:
- Patients with chronic obstructive pulmonary disease.
- Smokers.
- Ex smokers if smoked more than 5 pack years.
- Overt heart failure
- Known or predicted difficult intubation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Västmanlands sjukhus Köping
Köping, Västmanland County, 721 89, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lennart Edmark, Md
Landstinget Vastmaland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
July 26, 2013
First Posted
July 30, 2013
Study Start
August 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
August 26, 2014
Record last verified: 2014-08