Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Primary Purpose
Cardiopulmonary Arrest
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bag-Valve-Mask-Ventilation (Ambu Facemask)
Laryngeal Mask (Laryngeal Mask Airway Supreme)
Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
Sponsored by
About this trial
This is an interventional treatment trial for Cardiopulmonary Arrest focused on measuring Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation
Eligibility Criteria
Inclusion Criteria:
ASA I-II
-> 18 years old
- elective surgery in general anesthesia
Exclusion Criteria:
- Patient not sober
- BMI > 35kg/m2
- Pathologies of cerebral spine or peripheral neurological deficit
- Hiatus hernia, history of gastric reflux
- Stomach or Esophagus -Operation in the medical history
- Acute respiratory infection or obstructive lung disease
- Non elective surgery
- facial deformity
Sites / Locations
- Krankenhaus Bruneck
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Bag-Mask-Ventilation
Laryngeal Mask Ventilation
Laryngeal Tube Ventilation
Arm Description
Bag-Valve Mask-Ventilation in 50 patients in general anesthesia
Laryngeal Mask Ventilation in 50 patients in general anesthesia
Laryngeal Tube Ventilation in 50 patients in general anesthesia
Outcomes
Primary Outcome Measures
Airway Management time until first effective Ventilation
Effective Ventilation within 90 Seconds required
Secondary Outcome Measures
Stomach inflation
Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask
Full Information
NCT ID
NCT01452867
First Posted
October 12, 2011
Last Updated
October 14, 2011
Sponsor
Krankenhaus Bruneck
Collaborators
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT01452867
Brief Title
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Official Title
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krankenhaus Bruneck
Collaborators
Medical University Innsbruck
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Gaining evidence which ventilation technique may be most efficient and safe is of utmost importance to potentially improve outcome during cardiopulmonary resuscitation.
Detailed Description
During cardiopulmonary resuscitation (CPR) ventilation has to be efficient to provide oxygen to the body and safe to avoid potentially fatal regurgitation and aspiration pneumonia and excessive stomach inflation. Basically trained rescuers have severe problems to ventilate a patient during cardiopulmonary resuscitation. This study intends to compare three commonly employed ventilation techniques. First, the traditionally bag-valve mask ventilation is commonly taught during CPR course, despite recent evidence suggesting low efficiency rates. Second, the laryngeal mask and the laryngeal tube supraglottic airways have shown high efficiency and safety in previous studies in the hand of experienced clinicians. Until now it is unclear if basically trained rescuers are better in ventilation with bag valve mask ventilation or the supraglottic airway devices, the laryngeal mask and the laryngeal tube. The purpose of this study is to compare in anesthetised patients airway management and ventilation with bag-valve mask, laryngeal mask and laryngeal tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest
Keywords
Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bag-Mask-Ventilation
Arm Type
Active Comparator
Arm Description
Bag-Valve Mask-Ventilation in 50 patients in general anesthesia
Arm Title
Laryngeal Mask Ventilation
Arm Type
Active Comparator
Arm Description
Laryngeal Mask Ventilation in 50 patients in general anesthesia
Arm Title
Laryngeal Tube Ventilation
Arm Type
Active Comparator
Arm Description
Laryngeal Tube Ventilation in 50 patients in general anesthesia
Intervention Type
Device
Intervention Name(s)
Bag-Valve-Mask-Ventilation (Ambu Facemask)
Other Intervention Name(s)
Ambu Facemask
Intervention Description
Bag-Valve Mask-Ventilation
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask (Laryngeal Mask Airway Supreme)
Other Intervention Name(s)
Laryngeal Mask Airway Supreme
Intervention Description
Ventilation
Intervention Type
Device
Intervention Name(s)
Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
Other Intervention Name(s)
Laryngeal Tube LT-S-D (VBM)
Intervention Description
Ventilation
Primary Outcome Measure Information:
Title
Airway Management time until first effective Ventilation
Description
Effective Ventilation within 90 Seconds required
Time Frame
90 sec
Secondary Outcome Measure Information:
Title
Stomach inflation
Description
Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask
Time Frame
60 sec
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II
-> 18 years old
elective surgery in general anesthesia
Exclusion Criteria:
Patient not sober
BMI > 35kg/m2
Pathologies of cerebral spine or peripheral neurological deficit
Hiatus hernia, history of gastric reflux
Stomach or Esophagus -Operation in the medical history
Acute respiratory infection or obstructive lung disease
Non elective surgery
facial deformity
Facility Information:
Facility Name
Krankenhaus Bruneck
City
Bruneck
State/Province
Bolzano
ZIP/Postal Code
39031
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
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