Fresh FlowNCT04832256
Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels
An observational study of Fresh Flow and Carboxyhemoglobinemia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fresh Flow, Carboxyhemoglobinemia
- What is being tested?
- Radical-7 Pulse CO-Oximeter
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery
Who may be able to join
- ASA I-II
- Undergo 2-4 hours of elective surgery
Who cannot join
- Cardiovascular disease
- diabetes mellitus
- kidney, liver failure
- chronic obstructive pulmonary disease
- patients with opioid sensitivity
- morbidly obese
Show all 10Show fewer
- personal or family history of malignant hyperthermia
- history of prolonged recovery from anesthesia
- alcohol addicted
- pregnant and breastfeeding women patients allergic to study drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: 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.
- Conditions
- Fresh Flow, Carboxyhemoglobinemia
- Being tested
- Radical-7 Pulse CO-Oximeter
- Keywords
- Low flow anesthesia, Non-invasive carboxyhemoglobinemia monitoring, Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical-7 Pulse CO-OximeterDevice
COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)
| Study group | Role | What they receive |
|---|---|---|
| High Flow anesthesia | administered 4 L/min fresh gas flow during general anesthesia Receives: Device: Radical-7 Pulse CO-Oximeter | |
| Low Flow Anesthesia | administered 1 L/min fresh gas flow during general anesthesia Receives: Device: Radical-7 Pulse CO-Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during surgery
Secondary outcomes (1)
effects of smoking on carbon monoxide accumulation.
to determine the contribution of smoking to intraoperative carbon monoxide accumulation.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2018
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fresh FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengü Gülhan Aydin, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832256
- Sponsor's protocol ID
- 2015-67-07/07
- Status last verified
- May 2022
- First submitted
- 30 Mar 2021
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35964947
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Fresh Gas Flows on Carboxyhemoglobin Levels: Noninvasive Carbon Monoxide Monitoring
- ClinicalTrials.gov ID
- NCT04832256
- Acronym / sponsor ID
- 2015-67-07/07
- Conditions
- Fresh Flow, Carboxyhemoglobinemia
- Keywords
- Low flow anesthesia, Non-invasive carboxyhemoglobinemia monitoring, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow anesthesia | – | Device: Radical-7 Pulse CO-Oximeteradministered 4 L/min fresh gas flow during general anesthesia |
| Low Flow Anesthesia | – | Device: Radical-7 Pulse CO-Oximeteradministered 1 L/min fresh gas flow during general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 64 patients in ASA I-II risk group, aged 18-65, undergoing 2-4 hours of elective surgery
Key inclusion criteria (2 listed)
- ASA I-II
- Undergo 2-4 hours of elective surgery
Key exclusion criteria (10 listed)
- Cardiovascular disease
- diabetes mellitus
- kidney, liver failure
- chronic obstructive pulmonary disease
- patients with opioid sensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical-7 Pulse CO-OximeterCOHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA) | Device | High Flow anesthesia, Low Flow Anesthesia |
Primary outcome
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.
1 secondary outcome
effects of smoking on carbon monoxide accumulation.
Time frame: during surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Derived from this study: PubMed 35964947Koksal 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.
- Individual participant dataSharing planned: No
Related trials for Fresh Flow
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Fresh Gas Flow and Lung Ultrasonography in Laparoscopic Cholecystectomy
Postoperative Atelectasis, Pulmonary Atelectasis
Not yet recruitingObservational study
Assessment of Sevoflurane Consumption During General Anesthesia With a Low Fresh Gas Flow Rate of 0.3 L/Min
Anesthesia
RecruitingObservational study
Wash-in Period in Patients Undergoing Low Flow Anesthesia
Inhalation Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fresh Flow and Carboxyhemoglobinemia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects of different fresh gas flows on carboxyhemoglobin levels (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.