Anesthetic Ventilatory RequirementsNCT01339013
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia
A study testing Anesthetic Conserving Device (AnaConDa ) in people with Anesthetic Ventilatory Requirements, run by Region Skane at 1 site in Sweden.
Trial summary
The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthetic Ventilatory Requirements
- What is being tested?
- Anesthetic Conserving Device (AnaConDa )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- 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
University Hospital, Cardiothoracic Intensive Care
Lund, SE-221 85
About this study
Official title: Dead Space Effect of an Anaesthesia Gas Reflector (AnaConDa)
The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.
- Conditions
- Anesthetic Ventilatory Requirements
- Being tested
- Anesthetic Conserving Device (AnaConDa )
- Keywords
- Quantification, ventilatory requirements, charcoal filter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthetic Conserving Device (AnaConDa )Device
Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME does not.
| Study group | Role | What they receive |
|---|---|---|
| AnaConDa | Active comparator | Not described Receives: Device: Anesthetic Conserving Device (AnaConDa ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.
A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthetic Ventilatory RequirementsStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikael Bodelsson, Professor, Principal investigator, Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339013
- Sponsor's protocol ID
- 20110322
- Status last verified
- Sep 2014
- First submitted
- 13 Apr 2011
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sturesson LW, Bodelsson M, Johansson A, Jonson B, Malmkvist G. Apparent dead space with the anesthetic conserving device, AnaConDa(R): a clinical and laboratory investigation. Anesth Analg. 2013 Dec;117(6):1319-24. doi: 10.1213/ANE.0b013e3182a7778e.
PubMed 24257381
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dead Space Effect of an Anaesthesia Gas Reflector (AnaConDa)
- ClinicalTrials.gov ID
- NCT01339013
- Acronym / sponsor ID
- 20110322
- Conditions
- Anesthetic Ventilatory Requirements
- Keywords
- Quantification, ventilatory requirements, charcoal filter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anesthesia gas reflector (AnaConDa) is built on the adsorptive capacity of active carbon which also adsorbs carbon dioxide in exhaled air. Rebreathing of carbon dioxide thus occurs and must be compensated for by increased ventilation. This study aims at determining how much compensation must be given, based on the hypothesis that rebreathing depends on carbon dioxide level in blood and exhaled air.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AnaConDa | Active comparator | Device: Anesthetic Conserving Device (AnaConDa ) |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| Anesthetic Conserving Device (AnaConDa )Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME does not. | Device | AnaConDa |
Primary outcome
Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.
Time frame: 1 hour
A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24257381Sturesson LW, Bodelsson M, Johansson A, Jonson B, Malmkvist G. Apparent dead space with the anesthetic conserving device, AnaConDa(R): a clinical and laboratory investigation. Anesth Analg. 2013 Dec;117(6):1319-24. doi: 10.1213/ANE.0b013e3182a7778e.
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
Division 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 Anesthetic Conserving Device (AnaConDa ) in people with Anesthetic Ventilatory Requirements, 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 25 Sep 2014. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas. (time frame: 1 hour). 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 NCT01339013, 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 25 Sep 2014.