- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698863
Assessment of Oxygenation With Oxygen Reserve Index for General Anesthesia
January 8, 2021 updated by: Gamze Küçükosman, Zonguldak Bulent Ecevit University
Assessment of Oxygenation With Oxygen Reserve Index for Different Fresh Gas Flows in General Anesthesia Administration
To assess oxygenation with the oxygen reserve index in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.
Study Overview
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zonguldak, Turkey
- Zonguldak Bulent Ecevit University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Aged between 18-65 years undergoing tympanomastoidectomy surgery
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) risk class I-II,
- Undergoing tympanomastoidectomy
Exclusion Criteria:
- Morbid obesity
- Opioid sensitivity Alcohol or drug addiction
- Chronic obstructive pulmonary disease
- Coronary artery disease,
- Congestive heart failure
- Pronounced anemia
- Have a history of liver or kidney disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high flow rate
After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane.
Then the flow rate was set to 4 L/min for Group High flow rate.
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eveluating oxygen reserve in blood
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low flow rate
After intubation, patients had fresh gas flow with 50% O2/50% air for the first 10 minutes (3/3 L/min) and 6% desflurane.
Then the flow rate was set to 1 L/min for Group Low flow rate.
|
eveluating oxygen reserve in blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to assess oxygenation with the oxygen reserve index (ORI) in different fresh gas flows in general anesthesia.
Time Frame: During the surgery procedure
|
to assess oxygenation with the oxygen reserve index (ORI) in desflurane anesthesia administration using low and high fresh gas flows for tympanomastoidectomy surgeries.
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During the surgery procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 7, 2021
Study Record Updates
Last Update Posted (Actual)
January 12, 2021
Last Update Submitted That Met QC Criteria
January 8, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-221-07/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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