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

Status

Completed

Conditions

Intervention / Treatment

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

  • Turkey
      • Zonguldak, Turkey
        • Zonguldak Bülent Ecevit University

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.
Device: Oxygen reserve index
eveluating oxygen reserve in blood
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.
Device: Oxygen reserve index
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.
During the surgery procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

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

Keywords

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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