- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01339013
Rebreathing of Carbon Dioxide With a Device Used for Giving Inhalational Anaesthesia
September 12, 2014 updated by: Region Skane
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lund, Sweden, SE-221 85
- University Hospital, Cardiothoracic Intensive Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: AnaConDa
|
Standard HME was replaced by AnaConDa.
AnaConDa has charcoal filter, HME does not.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.
Time Frame: 1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mikael Bodelsson, Professor, Division of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ACTUAL)
January 1, 2013
Study Completion (ACTUAL)
January 1, 2013
Study Registration Dates
First Submitted
April 13, 2011
First Submitted That Met QC Criteria
April 19, 2011
First Posted (ESTIMATE)
April 20, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2014
Last Update Submitted That Met QC Criteria
September 12, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20110322
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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