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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01339013
First received: April 13, 2011
Last updated: September 10, 2014
Last verified: September 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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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:
  • Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Enrollment: 6
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AnaConDa Device: Anesthetic Conserving Device (AnaConDa )
Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME 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

Locations
Sweden
University Hospital, Cardiothoracic Intensive Care
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Mikael Bodelsson, Professor Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
  More Information

Publications:
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01339013     History of Changes
Other Study ID Numbers: 20110322
Study First Received: April 13, 2011
Results First Received: March 14, 2014
Last Updated: September 10, 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 September 11, 2014