AnesthesiaNCT06389669
Is Low Flow Anaesthesia Feasible?
An observational study of Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia
- How many people
- 785 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2024to 20 Sep 2024
- How long will I take part?
- 1 Day
- 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: ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.
Who may be able to join
- Patients undergoing surgery under general anaesthesia
Who cannot join
- Emergency operations
- Previously diagnosed heart, lung, liver and kidney disease
- Surgeries that may impair oxygenation (laparoscopic, Heart, Lung surgeries)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Flow Anaesthesia is Good But Feasible?
Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA.
Read the detailed description
ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.
Inhaler anaesthesia will be administered after anaesthesia induction and tracheal intubation. Fresh gas flow (FGF) will be determined as 1 l/min, MAC=1, FiO2=40% with target controlled automatic gas control mode (AGC). FGF will be decreased to 0.5 l/min 10 minutes after surgical incision, if successful, it will be decreased to 0.3 l/min 10 minutes later and it will be checked whether it is successful. The study will be terminated and FGF will be increased to 1 l/min again.
Demographic data of the patients and FGF levels that can provide FiO2=40% will be recorded.
- Conditions
- Anesthesia
- Keywords
- Low Flow Anaesthesia, Closed-Circuit Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Low Flow Anaesthesia
To determine the lowest amount of fresh gas flow, most suitable for the patient and, which can provide FiO2=40% level
Measured: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
Secondary outcomes (1)
Factors affecting oxygen consumption
To find out which of the patient's physical characteristics that affect oxygen consumption may be determinant.
Measured: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start23 May 2024
- Primary completion15 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- 785 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
- Investigators
- Yusuf Z Colak, Assoc.Prof., Principal investigator, Inonu University Anaesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389669
- Sponsor's protocol ID
- Inonu LTI
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Flow Anaesthesia is Good But Feasible?
- ClinicalTrials.gov ID
- NCT06389669
- Acronym / sponsor ID
- Inonu LTI
- Conditions
- Anesthesia
- Keywords
- Low Flow Anaesthesia, Closed-Circuit Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 785 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 23 May 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 29 Apr 2024 (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.
Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA.
Detailed description
ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.
Inhaler anaesthesia will be administered after anaesthesia induction and tracheal intubation. Fresh gas flow (FGF) will be determined as 1 l/min, MAC=1, FiO2=40% with target controlled automatic gas control mode (AGC). FGF will be decreased to 0.5 l/min 10 minutes after surgical incision, if successful, it will be decreased to 0.3 l/min 10 minutes later and it will be checked whether it is successful. The study will be terminated and FGF will be increased to 1 l/min again.
Demographic data of the patients and FGF levels that can provide FiO2=40% will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2 patients who will undergo elective surgery under general anaesthesia in 38 operating rooms of Inonu University Faculty of Medicine will be prospectively recruited for 3 months (May-June-July). Emergency cases, patients under the age of 18 and over 65, laparoscopic surgeries, heart-lung surgeries that may impair oxygenation will not be included in the study.
Key inclusion criteria (1 listed)
- Patients undergoing surgery under general anaesthesia
Key exclusion criteria (3 listed)
- Emergency operations
- Previously diagnosed heart, lung, liver and kidney disease
- Surgeries that may impair oxygenation (laparoscopic, Heart, Lung surgeries)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of Low Flow Anaesthesia
Time frame: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
To determine the lowest amount of fresh gas flow, most suitable for the patient and, which can provide FiO2=40% level
1 secondary outcome
Factors affecting oxygen consumption
Time frame: The measurement will start 10 minutes after the surgical incision and end 20 minutes later
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 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yusuf Z Colak, Assoc.Prof. principal investigator
Inonu University Anaesthesiology and Reanimation Department
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 Anesthesia, run by Inonu 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 1 inclusion and 3 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 Oct 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?
Feasibility of Low Flow Anaesthesia (time frame: The measurement will start 10 minutes after the surgical incision and end 20 minutes later). 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 3 Oct 2024.