General AnaesthesiaLFNCT02013869
Low Flow Anaesthesia, is There a Difference Between 2 Modern Anaesthetic Machines Using Different Gas Reservoir
A study testing Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas and Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated in people with General Anaesthesia, run by Jan Jakobsson at 1 site in Sweden.
Trial summary
To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anaesthesia
- What is being tested?
- Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas and Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- May 2015to Aug 2017
- Phase
- Interventional
- 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
Who may be able to join
- ASA 1-2 patient 18 - 65 years scheduled for elective surgery
Who cannot join
- ASA > 2 heart failure COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit
To study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent
Read the detailed description
Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below
- Conditions
- General Anaesthesia
- Being tested
- Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas, Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated
- Keywords
- fresh gas flow, quality of anaesthesia, minimal alveolar concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gasDevice
Desflurane Dialed setting 18 % on the machine gas vaporized
Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflatedDevice
Desflurane dialed 18% on the machine gas vaporized
| Study group | Role | What they receive |
|---|---|---|
| Flow-I | Experimental | Wash in of desflurane (SupraneR) in an anaesthesia machine without below, a new technique that do not have abag/reservoir that is compressed but pushes the gas into the patient. This technique uses far less of fresh gas volume. Thus lower anaesthetic gas will be consumed per hour.
The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used. Receives: Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas |
| Asys | Active comparator | Wash in of desflurane (Suprane) in conventional anaesthesia machine Asys, with the anaesthesia machine Asys that has a bag/reservoir that is compressed for insufflation of gas into the patient, thus it is expected that more gas will be consumed per hour.
The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used. Receives: Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach 1.5 MAC (minimal alveolar concentration) Et
The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups
Measured: 1 hour
Secondary outcomes (2)
amount of inhaled agent consumed ml/min
The vaporiser will be weighed before and after each case and the amount of vapor, desflurane, consumed during the anaesthesia will be calculated Gr/min.
Measured: 5 hours
Postoperative Quality of Recovery
Quality of recovery will be followed during the first 72 hours after anaesthesia
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionAug 2017
Why it stopped: Two of the sites withdraw, did not have capacity to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Jakobsson
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor-investigator, Jan Jakobsson, Karolinska Institutet
- Investigators
- Jan g Jakobsson, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013869
- Sponsor's protocol ID
- 201301
- Other IDs
- JJ201301
- Acronym
- LF
- Status last verified
- Mar 2024
- First submitted
- 29 Nov 2013
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Flow Anaesthesia; Cost-effectiveness of the Flow-I Anaesthesia Machine, a Comparison to Established Anaesthesia Delivery Unit
- ClinicalTrials.gov ID
- NCT02013869
- Acronym / sponsor ID
- LF / 201301
- Conditions
- General Anaesthesia
- Keywords
- fresh gas flow, quality of anaesthesia, minimal alveolar concentration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Two of the sites withdraw, did not have capacity to recruit patients
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jan JakobssonUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- May 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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 study the Flow-I breathing circle during low flow general anaesthesia, whether this non-below system has advantages reduced time to reach Et 1MAC (minimal alveolar concentration) and lower consumption of inhaled agent
Detailed description
Assessing whether there are clinical differences in anaesthetic performance between standard anaesthesia workstation including a below and the new Flow-I device without a below
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- We studied the time to reach a MAC value for two fifferent anaesthetic machines, Flow-i versus Aisys looking at the time to reach 1 MAC desflurane
| Arm | Type | Receives |
|---|---|---|
| Flow-I | Experimental | Device: Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gasWash in of desflurane (SupraneR) in an anaesthesia machine without below, a new technique that do not have abag/reservoir that is compressed but pushes the gas into the patient. This technique uses far less of fresh gas volume. Thus lower anaesthetic gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used. |
| Asys | Active comparator | Device: Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflatedWash in of desflurane (Suprane) in conventional anaesthesia machine Asys, with the anaesthesia machine Asys that has a bag/reservoir that is compressed for insufflation of gas into the patient, thus it is expected that more gas will be consumed per hour. The primary outcome is the amount of anaesthetic consumed, the decrease in liquid desflurane (SupraneR) in the vaporiser of the ananesthetic machine. The vaporizer will be weighed before and after the anaesthetic to define the amount used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2 patient 18 - 65 years scheduled for elective surgery
Key exclusion criteria (1 listed)
- ASA > 2 heart failure COPD
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 |
|---|---|---|
| Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gasDesflurane Dialed setting 18 % on the machine gas vaporized | Device | Flow-I |
| Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflatedDesflurane dialed 18% on the machine gas vaporized | Device | Asys |
Primary outcome
Time to reach 1.5 MAC (minimal alveolar concentration) Et
Time frame: 1 hour
The time needed, seconds, to increase the end tidal desflurane concentration during wash-in from a 1 MAC to a 1.5 MAC with a constant fresh gas flow of 1 L/min and the vaporiser set a 3 MAC ( minimal alveolar concentration) (18%) will be compared between the two study groups
2 secondary outcomes
amount of inhaled agent consumed ml/min
Time frame: 5 hours
Postoperative Quality of Recovery
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Two of the sites withdraw, did not have capacity to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Jan g Jakobsson, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow-I, a modern anaesthetic machine without a bag/below/gas reservoir for compression of insufflation gas and Asys, a anaesthetic machine with a bag/bellow for compression of gas to be insufflated in people with General Anaesthesia, run by Jan Jakobsson at 1 site in Sweden.
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 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: stopped early, as of the sponsor's last update on 19 Mar 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 Sweden. 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 was stopped early (reason given: Two of the sites withdraw, did not have capacity to recruit patients). Results are not available in the source record.
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?
Time to reach 1.5 MAC (minimal alveolar concentration) Et (time frame: 1 hour). 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 19 Mar 2024.