Ischemic Heart DiseaseNCT01699802
Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
A study testing Inhaled anaesthetic agent in people with Ischemic Heart Disease, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled anaesthetic agent. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Inhaled anaesthetic agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Dec 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective coronary artery by-pass graft surgery
- elective valve replacement surgery
- normal left ventricular ejection fraction on preoperative echocardiography
Who cannot join
- obstructive lung disease
- restrictive lung disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skane University Hospital Lund, Cardiothoracic Intensive Care
Lund, SE-221 85
About this study
The purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled anaesthetic agent.
The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon dioxide.
- Conditions
- Ischemic Heart Disease
- Being tested
- Inhaled anaesthetic agent
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled anaesthetic agentOther
| Study group | Role | What they receive |
|---|---|---|
| Inhaled anaesthetic agent | Experimental | The group where the investigators adds inhaled anaesthetic agent when using the anaesthetic gas reflector (AnaConda). Receives: Other: Inhaled anaesthetic agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of carbon dioxide rebreathing from an anesthetic gas reflector
Tidal carbon dioxide volume rebreathed from an anesthetic gas reflector correlated to concentration of delivered anesthetic gas.
Measured: 2 hours
Secondary outcomes (1)
Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector.
Changes of tidal volume required to maintain constant alveolar ventilation will be assessed by continuous measurement of exhaled tidal carbon dioxide volume, the latter to be maintained at a constant value.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikael Bodelsson, Professor, Principal investigator, Divison of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699802
- Sponsor's protocol ID
- 2012/148
- Status last verified
- May 2015
- First submitted
- 25 Sep 2012
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
- ClinicalTrials.gov ID
- NCT01699802
- Acronym / sponsor ID
- 2012/148
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Oct 2012 (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.
The purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled anaesthetic agent.
The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon dioxide.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled anaesthetic agent | Experimental | Other: Inhaled anaesthetic agentThe group where the investigators adds inhaled anaesthetic agent when using the anaesthetic gas reflector (AnaConda). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective coronary artery by-pass graft surgery
- elective valve replacement surgery
- normal left ventricular ejection fraction on preoperative echocardiography
Key exclusion criteria (2 listed)
- obstructive lung disease
- restrictive lung disease
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 |
|---|---|---|
| Inhaled anaesthetic agent | Other | Inhaled anaesthetic agent |
Primary outcome
Volume of carbon dioxide rebreathing from an anesthetic gas reflector
Time frame: 2 hours
Tidal carbon dioxide volume rebreathed from an anesthetic gas reflector correlated to concentration of delivered anesthetic gas.
1 secondary outcome
Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector.
Time frame: 2 hours
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 14 May 2015.
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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.
Mikael Bodelsson, Professor principal investigator
Divison of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled anaesthetic agent in people with Ischemic Heart Disease, run by Region Skane 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 3 inclusion and 2 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 14 May 2015. 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 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?
Volume of carbon dioxide rebreathing from an anesthetic gas reflector (time frame: 2 hours). 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 14 May 2015.