Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01339013
First received: April 13, 2011
Last updated: March 4, 2014
Last verified: February 2014
  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)

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: April 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Region Skane

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 4, 2014
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 August 28, 2014