Carbon Monoxide ExposureNCT05661045
The Effect of Blood Carboxyhemoglobin Levels on Total Antioxidant (Tas), Total Oxidant(Tos), Hypoxia Inducible Factor-1a (hif1a) During Low-flow and Normal-flow Anesthesia
An observational study of Carbon Monoxide Exposure, run by Ataturk Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In contrast to toxic CO concentrations, low-dose CO acts as a signaling molecule and can exert many complex cytoprotective effects. Therefore, the effects of low-dose CO are being investigated and developed as a new treatment method for use in various disease processes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carbon Monoxide Exposure
- What is being tested?
- low-flow anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 2 Jun 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-80, without systemic disease, non-smoker, who will undergo elective surgery under general anesthesia
Who may be able to join
- 18-70 years old
- ASA I-II
- none-smoking
- without systemic disease
- elective surgery with general anesthesia
Who cannot join
- over 70 years old
- with cardiovascular disease
- with respiratory system disease
- liver or kidney disease
- pregnant or nursing female patient
- those who do not want to participate
Show all 11Show fewer
- patient with multi-trauma
- ASA III and above
- emergency surgery
- surgery with blood transfusion
- smokers
Trial locations and contacts
1 site in 1 country.
About this study
In contrast to toxic CO concentrations, low-dose CO acts as a signaling molecule and can exert many complex cytoprotective effects. Therefore, the effects of low-dose CO are being investigated and developed as a new treatment method for use in various disease processes. However, these studies are mostly in vivo and in vitro studies and clinical studies have not reached a sufficient number. In this study, the effect of subclinical COHB levels on biomarkers such as TAS, TOS, HIF-1α will be evaluated.
Read the detailed description
130 patients aged between 18 and 70 with ASA I-II will be included in the study. Patients will be assigned to one of the two study groups in equal numbers using a computerized random numbers table.
In the 1st group (Group DA), the patients will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min (low flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for COHB and biochemistry analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.
Patients in group 2 (Group NA) will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min (normal flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for COHB and biochemistry analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.
SPSS 25.0 (IBM Corporation, Armonk, New York, United States) program will be used in the statistical analysis of the variables obtained as a result of the study. The conformity of the data to the normal distribution will be evaluated with the Shapiro-Wilk test and the homogeneity of variance with the Levene test. Independent sample t test and Mann Whitney u test will be used to compare two groups with each other according to quantitative data. In order to examine the correlations of the variables with each other, appropriate ones from Pearson Correlation, Kendall's tau-b and Spearman's rho tests will be used considering the distribution of the data. According to the results of the correlation analysis, it will be supported by regression analysis when necessary. Pearson Chi-Square and Fisher Exact tests will be used to compare categorical variables with each other. Quantitative variables will be shown in the tables as mean (standard deviation) and median (Maximum-Minimum), and categorical variables as n(%). Variables will be analyzed at 95% confidence level and p value less than 0.05 will be considered significant.
- Conditions
- Carbon Monoxide Exposure
- Being tested
- low-flow anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-flow anesthesiaProcedure or surgery
Changes in blood carboxyhemoglobin levels as a result of exposure to rebreathing during low-flow anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group DA | In the Group (DA), the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated.Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min and fentanyl,rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis. Receives: Procedure: low-flow anesthesia | |
| Group NA | In the Group (NA),the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2),non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis.After induction of anesthesia with propofol and rocuronium, patients will be intubated. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min and fentanyl, rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohb
carboxyhemoglobin
Measured: t1: first hour of surgery
tas
total antioxidant status
Measured: t1: first hour of surgery
tos
total oxidant status
Measured: t1: first hour of surgery
hif-1α
hypoxia inducible factor 1α
Measured: t1: first hour of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start2 Jan 2023
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carbon Monoxide ExposureStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vkoksal, Ataturk Training and Research Hospital
- Investigators
- VEYSEL KOKSAL, PROF ASS, Principal investigator, same
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661045
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/1
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2022
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bauer I, Pannen BH. Bench-to-bedside review: Carbon monoxide--from mitochondrial poisoning to therapeutic use. Crit Care. 2009;13(4):220. doi: 10.1186/cc7887. Epub 2009 Aug 14.
PubMed 19691819Lee SJ, Ryter SW, Xu JF, Nakahira K, Kim HP, Choi AM, Kim YS. Carbon monoxide activates autophagy via mitochondrial reactive oxygen species formation. Am J Respir Cell Mol Biol. 2011 Oct;45(4):867-73. doi: 10.1165/rcmb.2010-0352OC. Epub 2011 Mar 25.
PubMed 21441382
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Carboxyhemoglobin Levels on Total Antioxidant (Tas), Total Oxidant(Tos), Hypoxia Inducible Factor-1a (hif1a) During Low-flow and Normal-flow Anesthesia
- ClinicalTrials.gov ID
- NCT05661045
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/1
- Conditions
- Carbon Monoxide Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 22 Dec 2022 (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.
In contrast to toxic CO concentrations, low-dose CO acts as a signaling molecule and can exert many complex cytoprotective effects. Therefore, the effects of low-dose CO are being investigated and developed as a new treatment method for use in various disease processes. However, these studies are mostly in vivo and in vitro studies and clinical studies have not reached a sufficient number. In this study, the effect of subclinical COHB levels on biomarkers such as TAS, TOS, HIF-1α will be evaluated.
Detailed description
130 patients aged between 18 and 70 with ASA I-II will be included in the study. Patients will be assigned to one of the two study groups in equal numbers using a computerized random numbers table.
In the 1st group (Group DA), the patients will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min (low flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for COHB and biochemistry analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.
Patients in group 2 (Group NA) will be taken to the operating table. The standard consisting of electrocardiogram (ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored. Prior to induction, the first blood sample (To) will be drawn for COHB and biochemistry analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated orotracheal. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min (normal flow anaesthesia) and fentanyl and rocuronium will be administered intermittently. Patients will be ventilated with a ring system ventilator with a newly changed absorber at a constant tidal volume (body weight kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for COHB and biochemistry analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken from the patients at the postoperative 24th hour in the service for COHB and biochemistry analysis. Blood carboxyhemoglobin (COHB), total antioxidant status (TAS), total oxidant status (TOS), Hypoxia-inducible factor 1α (HIF-1α) values will be calculated.
SPSS 25.0 (IBM Corporation, Armonk, New York, United States) program will be used in the statistical analysis of the variables obtained as a result of the study. The conformity of the data to the normal distribution will be evaluated with the Shapiro-Wilk test and the homogeneity of variance with the Levene test. Independent sample t test and Mann Whitney u test will be used to compare two groups with each other according to quantitative data. In order to examine the correlations of the variables with each other, appropriate ones from Pearson Correlation, Kendall's tau-b and Spearman's rho tests will be used considering the distribution of the data. According to the results of the correlation analysis, it will be supported by regression analysis when necessary. Pearson Chi-Square and Fisher Exact tests will be used to compare categorical variables with each other. Quantitative variables will be shown in the tables as mean (standard deviation) and median (Maximum-Minimum), and categorical variables as n(%). Variables will be analyzed at 95% confidence level and p value less than 0.05 will be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DA | – | Procedure: low-flow anesthesiaIn the Group (DA), the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2), and non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis. After induction of anesthesia with propofol and rocuronium, he will be intubated.Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 0.6 L/min and fentanyl,rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). At the 1st hour of low flow anesthesia maintenance, a second blood sample (T1) will be taken for analysis. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis. |
| Group NA | – | –In the Group (NA),the standard consisting of electrocardiogram(ECG), peripheral oxygen saturation (Spo2),non-invasive blood pressure will be monitored.Prior to induction, the first blood sample (To) will be taken for analysis.After induction of anesthesia with propofol and rocuronium, patients will be intubated. Anesthesia will be maintained with desflurane (MAC:1), oxygen (50%), air (50%). After a high flow phase of 4 l/min for 10 min, the fresh gas flow will be reduced to 2.0 L/min and fentanyl, rocuronium will be administered intermittently. Patients will be ventilated with a ventilator at a constant tidal volume (kg x 6 mL) and respiratory rate (12/min). A second blood sample (T1) will be taken for analysis at the 1st hour of normal flow anesthesia maintenance. Patients will be awakened at the end of the case. After the recovery room, it will be transferred to the relevant service. A third blood sample (T2) will be taken at the postoperative 24th hour in the service for analysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80, without systemic disease, non-smoker, who will undergo elective surgery under general anesthesia
Key inclusion criteria (5 listed)
- 18-70 years old
- ASA I-II
- none-smoking
- without systemic disease
- elective surgery with general anesthesia
Key exclusion criteria (11 listed)
- over 70 years old
- with cardiovascular disease
- with respiratory system disease
- liver or kidney disease
- pregnant or nursing female patient
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 |
|---|---|---|
| low-flow anesthesiaChanges in blood carboxyhemoglobin levels as a result of exposure to rebreathing during low-flow anaesthesia. | Procedure or surgery | Group DA |
Primary outcome
Cohb
Time frame: t1: first hour of surgery
carboxyhemoglobin
tas
Time frame: t1: first hour of surgery
total antioxidant status
tos
Time frame: t1: first hour of surgery
total oxidant status
hif-1α
Time frame: t1: first hour of surgery
hypoxia inducible factor 1α
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 17 Jun 2024.
- Results publication: PubMed 19691819Bauer I, Pannen BH. Bench-to-bedside review: Carbon monoxide--from mitochondrial poisoning to therapeutic use. Crit Care. 2009;13(4):220. doi: 10.1186/cc7887. Epub 2009 Aug 14.
- Results publication: PubMed 21441382Lee SJ, Ryter SW, Xu JF, Nakahira K, Kim HP, Choi AM, Kim YS. Carbon monoxide activates autophagy via mitochondrial reactive oxygen species formation. Am J Respir Cell Mol Biol. 2011 Oct;45(4):867-73. doi: 10.1165/rcmb.2010-0352OC. Epub 2011 Mar 25.
- Individual participant dataSharing planned: No
Related trials for Carbon Monoxide Exposure
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Effects of CO Level on Pain, Sensory Function, and Subjective Health
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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.
VEYSEL KOKSAL, PROF ASS principal investigator
same
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 Carbon Monoxide Exposure, run by Ataturk Training and Research Hospital 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 5 inclusion and 11 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 17 Jun 2024. 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?
Cohb (time frame: t1: first hour of surgery). The study lists 4 primary outcomes in all. 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 NCT05661045, which also lists 2 linked publications.
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 17 Jun 2024.