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
Results First Received: March 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Anesthetic Ventilatory Requirements
Intervention: Device: Anesthetic Conserving Device (AnaConDa )

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
September 2011 to January 2013, Medical Clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All recruited patients participated uneventfully.

Reporting Groups
  Description
AnaConDa Replaces the Heat and Moisture Exchanger The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.

Participant Flow:   Overall Study
    AnaConDa Replaces the Heat and Moisture Exchanger  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
A total of 6 patients participated. All 6 started with HME, then AnaConDa, finally HME

Reporting Groups
  Description
All Study Participants Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  6  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 58 to 75 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     2  
Gender  
[units: participants]
 
Female     1  
Male     5  
Region of Enrollment  
[units: participants]
 
Sweden     6  



  Outcome Measures

1.  Primary:   Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Louise Walther Sturesson
Organization: Region Skane, Lund University Hospital, Lund, Sweden
phone: +46 46 171953
e-mail: louise.waltersturesson@skane.se


Publications of Results:

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 12, 2014
Health Authority: Sweden: Medical Products Agency