Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 12, 2014
Last verified: September 2014

April 13, 2011
September 12, 2014
April 2011
January 2013   (final data collection date for primary outcome measure)
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. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.
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.
Complete list of historical versions of study NCT01339013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Anesthetic Ventilatory Requirements
Device: Anesthetic Conserving Device (AnaConDa )
Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME does not.
Active Comparator: AnaConDa
Intervention: Device: Anesthetic Conserving Device (AnaConDa )
Sturesson LW, Bodelsson M, Johansson A, Jonson B, Malmkvist G. Apparent dead space with the anesthetic conserving device, AnaConDa®: a clinical and laboratory investigation. Anesth Analg. 2013 Dec;117(6):1319-24. doi: 10.1213/ANE.0b013e3182a7778e.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01339013
20110322
No
Region Skane
Region Skane
Not Provided
Principal Investigator: Mikael Bodelsson, Professor Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
Region Skane
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP