Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels

May 1, 2022 updated by: Bengü Gülhan Aydin, Zonguldak Bulent Ecevit University

Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels: Noninvasive Carbon Monoxide Monitoring

To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level non-invasively and continuous measurement and to determine the contribution of smoking to the intraoperative carbon monoxide accumulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

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
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery

Description

Inclusion Criteria:

  • ASA I-II
  • Undergo 2-4 hours of elective surgery

Exclusion Criteria:

  • Cardiovascular disease
  • diabetes mellitus
  • kidney, liver failure
  • chronic obstructive pulmonary disease
  • patients with opioid sensitivity
  • morbidly obese
  • personal or family history of malignant hyperthermia
  • history of prolonged recovery from anesthesia
  • alcohol addicted
  • pregnant and breastfeeding women patients allergic to study drugs

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Flow anesthesia
administered 4 L/min fresh gas flow during general anesthesia
Device: Radical-7 Pulse CO-Oximeter
COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)
Low Flow Anesthesia
administered 1 L/min fresh gas flow during general anesthesia
Device: Radical-7 Pulse CO-Oximeter
COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of different fresh gas flows on carboxyhemoglobin levels
Time Frame: during surgery
To observe the effect of different fresh flows (1 L / min and 4 L / min) on the carboxyhemoglobin level by non-invasive and continuous measurement.
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of smoking on carbon monoxide accumulation.
Time Frame: during surgery
to determine the contribution of smoking to intraoperative carbon monoxide accumulation.
during surgery

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2016

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (ACTUAL)

April 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

May 1, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-67-07/07

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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