General AnesthesiaNCT04204746
The Affecting Factors on Airway Temperature and Moisture
An observational study of General Anesthesia, run by Selcuk University.
Trial summary
There is no literature information about the flow rate of fresh gas mixture (air+O2) in the patients who underwent general anesthesia. Different flow rates of fresh gas mixture are used in both the investigator's hospital and the experiences of the anesthesiologists. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were aged between 18-65 years and underwent surgery with general anesthesia.
Who may be able to join
- Patients aged 18-65 years underwent general anesthesia -
- Exclusion Criteria:admitted to emergency and trauma, history of advanced cardiac disease, cigarette use ≥ 3 packet/day, pulmonary parenchymal disease such as malignancy or chronic obstructive pulmonary disease (COPD), history of thyroid disease, body mass index (BMI) greater than 30 kg/m2, alcohol and substance addiction, mentally deficiency, pregnancy or postpartum, fever and infection, drug use such that would influence thermoregulation such as vasodilators, hemorrhage > 5 mL/kg, and patients who declined to participate.
- -
Who cannot join
None listed.
About this study
Official title: The Effects of Different Fresh Gas Flows and Different Anesthetics on Airway Temperature and Moisture in Patients Who Underwent General Anesthesia
There is no literature information about the flow rate of fresh gas mixture (air+O2) in the patients who underwent general anesthesia. Different flow rates of fresh gas mixture are used in both the investigator's hospital and the experiences of the anesthesiologists. It is aimed to study the effects of different fresh gas flow rates on the rate of temperature and moisture of the airway of patients who underwent general anesthesia.
Read the detailed description
Under physiological conditions, inhaled air is heated and humidified as it passes through the nose and upper airways until reaching the alveoli. This mechanism is bypassed by endotracheal intubation. Ventilation with dry and cold compressed gases leads to loss of water and heat from the respiratory tract. Drying of the respiratory tract can lead to destruction of the cilia and mucous membranes, resulting in decreased mucociliary transport and increased concentration of secretions.There is no definitive literature on fresh gas mix (oxygen + air) flow rates in patients under general anesthesia. This study aimed to investigate whether two fresh gas flow rates routinely employed in the authors' practice affected airway temperature and humidity.
- Conditions
- General Anesthesia
- Being tested
- We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.
- Keywords
- general anesthesia, fresh gas, moisture, temperature, respiratory circuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.Other
| Study group | Role | What they receive |
|---|---|---|
| 3 lt/min | Patients in the study were divided into two main groups according to the standard fresh gas flow administered (3-6 L/min). Each main group was then divided into subgroups as follows: sevoflurane + remifentanil, desflurane + remifentanil, or propofol + remifentanil (TIVA). These six groups were further divided into two groups according to use or non-use of a heat and moisture exchanger (HME) filter. Receives: Other: We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer. | |
| 6 lt/min | Patients in the study were divided into two main groups according to the standard fresh gas flow administered (3-6 L/min). Each main group was then divided into subgroups as follows: sevoflurane + remifentanil, desflurane + remifentanil, or propofol + remifentanil (TIVA). These six groups were further divided into two groups according to use or non-use of a heat and moisture exchanger (HME) filter. Receives: Other: We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affect of two fresh gas flow rates (3lt/ 6lt min) on patients' airway temperature and humidity.
We will evaluate if different fresh gas flows effect on patients' airway temperature and moisture. We will evaluate by using a thermo-hygrometer fixed on anesthesia circuit.
Measured: 2016-2018
Secondary outcomes (1)
Affect of different anesthetic gases (sevoflurane, desflurane) and drugs (propofol)on patients' airway temperature and humidity.
We will evaluate if different anesthetic gases (sevoflurane, desflurane) and drugs (propofol) effect on patients' airway temperature and moisture. We will evaluate by using a thermo-hygrometer fixed on anesthesia circuit.
Measured: 2016-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Apr 2016
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Onal, Selcuk University
- Investigators
- Ozkan Onal, Professor, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204746
- Sponsor's protocol ID
- E.90598
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The type(s) of supporting information that will be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
Publications
Ozcan IG, Onal O, Ozdemirkan A, Saltali A, Sari M. Effects of different fresh gas flows and different anesthetics on airway temperature and humidity in surgical patients: a prospective observational study. Med Gas Res. 2022 Jul-Sep;12(3):83-90. doi: 10.4103/2045-9912.330691.
PubMed 34854418
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Fresh Gas Flows and Different Anesthetics on Airway Temperature and Moisture in Patients Who Underwent General Anesthesia
- ClinicalTrials.gov ID
- NCT04204746
- Acronym / sponsor ID
- E.90598
- Conditions
- General Anesthesia
- Keywords
- general anesthesia, fresh gas, moisture, temperature, respiratory circuit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 19 Dec 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.
There is no literature information about the flow rate of fresh gas mixture (air+O2) in the patients who underwent general anesthesia. Different flow rates of fresh gas mixture are used in both the investigator's hospital and the experiences of the anesthesiologists. It is aimed to study the effects of different fresh gas flow rates on the rate of temperature and moisture of the airway of patients who underwent general anesthesia.
Detailed description
Under physiological conditions, inhaled air is heated and humidified as it passes through the nose and upper airways until reaching the alveoli. This mechanism is bypassed by endotracheal intubation. Ventilation with dry and cold compressed gases leads to loss of water and heat from the respiratory tract. Drying of the respiratory tract can lead to destruction of the cilia and mucous membranes, resulting in decreased mucociliary transport and increased concentration of secretions.There is no definitive literature on fresh gas mix (oxygen + air) flow rates in patients under general anesthesia. This study aimed to investigate whether two fresh gas flow rates routinely employed in the authors' practice affected airway temperature and humidity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 lt/min | – | Other: We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.Patients in the study were divided into two main groups according to the standard fresh gas flow administered (3-6 L/min). Each main group was then divided into subgroups as follows: sevoflurane + remifentanil, desflurane + remifentanil, or propofol + remifentanil (TIVA). These six groups were further divided into two groups according to use or non-use of a heat and moisture exchanger (HME) filter. |
| 6 lt/min | – | Other: We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.Patients in the study were divided into two main groups according to the standard fresh gas flow administered (3-6 L/min). Each main group was then divided into subgroups as follows: sevoflurane + remifentanil, desflurane + remifentanil, or propofol + remifentanil (TIVA). These six groups were further divided into two groups according to use or non-use of a heat and moisture exchanger (HME) filter. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were aged between 18-65 years and underwent surgery with general anesthesia.
Key inclusion criteria (3 listed)
- Patients aged 18-65 years underwent general anesthesia -
- Exclusion Criteria:admitted to emergency and trauma, history of advanced cardiac disease, cigarette use ≥ 3 packet/day, pulmonary parenchymal disease such as malignancy or chronic obstructive pulmonary disease (COPD), history of thyroid disease, body mass index (BMI) greater than 30 kg/m2, alcohol and substance addiction, mentally deficiency, pregnancy or postpartum, fever and infection, drug use such that would influence thermoregulation such as vasodilators, hemorrhage > 5 mL/kg, and patients who declined to participate.
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer. | Other | 3 lt/min, 6 lt/min |
Primary outcome
Affect of two fresh gas flow rates (3lt/ 6lt min) on patients' airway temperature and humidity.
Time frame: 2016-2018
We will evaluate if different fresh gas flows effect on patients' airway temperature and moisture. We will evaluate by using a thermo-hygrometer fixed on anesthesia circuit.
1 secondary outcome
Affect of different anesthetic gases (sevoflurane, desflurane) and drugs (propofol)on patients' airway temperature and humidity.
Time frame: 2016-2018
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 20 Dec 2019.
- Derived from this study: PubMed 34854418Ozcan IG, Onal O, Ozdemirkan A, Saltali A, Sari M. Effects of different fresh gas flows and different anesthetics on airway temperature and humidity in surgical patients: a prospective observational study. Med Gas Res. 2022 Jul-Sep;12(3):83-90. doi: 10.4103/2045-9912.330691.
- Individual participant dataSharing planned: Yes. The type(s) of supporting information that will be shared, in addition to the individual participant data set and data dictionaries for the IPD itself.
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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.
Ozkan Onal, Professor principal investigator
Selcuk University
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia, run by Selcuk University.
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 3 inclusion and 0 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Affect of two fresh gas flow rates (3lt/ 6lt min) on patients' airway temperature and humidity. (time frame: 2016-2018). 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 NCT04204746, 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 20 Dec 2019.