NCT04832256

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

March 30, 2021

Last Update Submit

May 1, 2022

Conditions

Keywords

Low flow anesthesiaNon-invasive carboxyhemoglobinemia monitoringSmoking

Outcome Measures

Primary Outcomes (1)

  • effects of different fresh gas flows on carboxyhemoglobin levels

    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 Outcomes (1)

  • effects of smoking on carbon monoxide accumulation.

    during surgery

Study Arms (2)

High Flow anesthesia

administered 4 L/min fresh gas flow during general anesthesia

Device: Radical-7 Pulse CO-Oximeter

Low Flow Anesthesia

administered 1 L/min fresh gas flow during general anesthesia

Device: Radical-7 Pulse CO-Oximeter

Interventions

COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)

High Flow anesthesiaLow Flow Anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (1)

  • Koksal BG, Kucukosman G, Ozcan P, Baytar C, Bollucuoglu K, Okyay RD, Ayoglu H. Effects of different fresh gas flows on carboxyhemoglobin levels: non-invasive carbon monoxide monitoring: A randomized clinical trial. Saudi Med J. 2022 Aug;43(8):891-898. doi: 10.15537/smj.2022.43.8.20220424.

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 5, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2018

Study Completion

June 1, 2019

Last Updated

May 3, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations