Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia
This study is currently recruiting participants.
Verified March 2013 by Region Skane
Sponsor:
Region Skane
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01339013
First received: April 13, 2011
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anesthetic Ventilatory Requirements |
Device: Anesthetic Conserving Device (AnaConDa ) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Dead Space Effect of an Anaesthesia Gas Reflector (AnaConDa) |
Resource links provided by NLM:
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Quantification of ventilation requirements with the use of the AnaConDa rebreathing system for anesthetic gases [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Changes to 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.
| Estimated Enrollment: | 12 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Active AnaConDa |
Device: Anesthetic Conserving Device (AnaConDa )
Active AnaConDa has charcoal filter, inactive does not.
|
| Active Comparator: Inactive AnaConDa |
Device: Anesthetic Conserving Device (AnaConDa )
Active AnaConDa has charcoal filter, inactive does not.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- elective coronary artery by-pass graft surgery
- elective valve replacement surgery
- normal left ventricular ejection fraction on preoperative echocardiography
Exclusion Criteria:
- obstructive lung disease
- restrictive lung disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339013
Contacts
| Contact: Gunnar Malmkvist, M.D., Ph.D. | +46 46 171035 |
Locations
| Sweden | |
| University Hospital, Cardiothoracic Intensive Care | Recruiting |
| Lund, Sweden, SE-221 85 | |
| Contact: Louise C Walther Sturesson, M.D. +46 46 171953 | |
| Principal Investigator: Louise C Walther Sturesson, M.D. | |
Sponsors and Collaborators
Region Skane
Investigators
| Principal Investigator: | Mikael Bodelsson, Professor | Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden |
More Information
No publications provided
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT01339013 History of Changes |
| Other Study ID Numbers: | 20110322 |
| Study First Received: | April 13, 2011 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Region Skane:
|
Quantification ventilatory requirements charcoal filter |
Additional relevant MeSH terms:
|
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013