Environmental-Pollution-Related ConditionNCT04124562
Nitrous Oxide Frequency of Use and Causes in Hospital in Turkey
An observational study of Environmental-Pollution-Related Condition, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of nitrous oxide use in hospitals in Turkey Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Environmental-Pollution-Related Condition
- What is being tested?
- Nitrous Oxide
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 15 Nov 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 Any age
- Child, Adult, Older adult
Study population: Anesthesiologists working in the operating rooms of hospitals in Turkey
Who may be able to join
- Hospitals who accept to participate in Turkey
- -
Who cannot join
- Hospitals refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, School of Medicine
Van, Tusba / Zeve Kampus, 65080
About this study
The prevalence of nitrous oxide use in hospitals in Turkey
Read the detailed description
Nitrous oxide has a long history of use in the healthcare field for over 150 years. However, this gas is slowly being abandoned for various reasons. The decrease in N2O use is probably due to its side effects and negative impact on global warming. Proven side effects include irreversible toxic effects on bone marrow, relative or absolute contraindications related to neuro and cardiac anesthesia, increased incidence of post-operative nausea and vomiting, increased risk of miscarriage in pregnant women (5), the greenhouse effect of nitrous oxide. In 2013, B. Husum et al. investigated the frequency of N2O use in public hospitals in Scandinavian countries and it was confirmed that N2O use was reduced and limited. According to the results of this research, N2O was administered with a volatile anesthetic agent in 21.5% of general anesthesia applications in Scandinavian countries. N2O was used as the second agent in Denmark by 2.4%, Finland by 17%, Iceland by 34.5, Norway by 32.1%, Sweden by 27.5%. In Turkey there are not enough reports of N2O use prevalence. In this study, we will investigate the extent of use and avoidance reasons N2O in Turkey. And we aim creating awareness.
- Being tested
- Nitrous Oxide
- Keywords
- Nitrous oxide, Prevalence, Turkey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideOther
Nitrous Oxide use ratio in Turkey's hospitals
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of nitrogen oxide use
Percentage of nitrogen oxide use in a daily general anesthesia practice
Measured: A day
Secondary outcomes (1)
The percentage of nitrogen oxide use
Percentage of nitrogen oxide use in a monthly general anesthesia practice
Measured: A month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start15 Oct 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental-Pollution-Related ConditionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilmi Demirkiran, MD, Yuzuncu Yil University
- Investigators
- Hilmi Demirkıran, 1, Principal investigator, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124562
- Sponsor's protocol ID
- Nitrous oxide
- Status last verified
- Jan 2020
- First submitted
- 8 Oct 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrous Oxide Frequency of Use and Causes in Hospital in Turkey
- ClinicalTrials.gov ID
- NCT04124562
- Acronym / sponsor ID
- Nitrous oxide
- Keywords
- Nitrous oxide, Prevalence, Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 11 Oct 2019 (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.
The prevalence of nitrous oxide use in hospitals in Turkey
Detailed description
Nitrous oxide has a long history of use in the healthcare field for over 150 years. However, this gas is slowly being abandoned for various reasons. The decrease in N2O use is probably due to its side effects and negative impact on global warming. Proven side effects include irreversible toxic effects on bone marrow, relative or absolute contraindications related to neuro and cardiac anesthesia, increased incidence of post-operative nausea and vomiting, increased risk of miscarriage in pregnant women (5), the greenhouse effect of nitrous oxide. In 2013, B. Husum et al. investigated the frequency of N2O use in public hospitals in Scandinavian countries and it was confirmed that N2O use was reduced and limited. According to the results of this research, N2O was administered with a volatile anesthetic agent in 21.5% of general anesthesia applications in Scandinavian countries. N2O was used as the second agent in Denmark by 2.4%, Finland by 17%, Iceland by 34.5, Norway by 32.1%, Sweden by 27.5%. In Turkey there are not enough reports of N2O use prevalence. In this study, we will investigate the extent of use and avoidance reasons N2O in Turkey. And we aim creating awareness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiologists working in the operating rooms of hospitals in Turkey
Key inclusion criteria (2 listed)
- Hospitals who accept to participate in Turkey
- -
Key exclusion criteria (1 listed)
- Hospitals refusing to participate in the study
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 |
|---|---|---|
| Nitrous OxideNitrous Oxide use ratio in Turkey's hospitals | Other | – |
Primary outcome
The percentage of nitrogen oxide use
Time frame: A day
Percentage of nitrogen oxide use in a daily general anesthesia practice
1 secondary outcome
The percentage of nitrogen oxide use
Time frame: A month
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 28 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Hilmi Demirkıran, 1 principal investigator
Study Director
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 Environmental-Pollution-Related Condition, run by Yuzuncu Yil 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 1 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 28 Jan 2020. 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?
The percentage of nitrogen oxide use (time frame: A day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.