Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedOctober 17, 2011
October 1, 2011
6 months
October 12, 2011
October 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Airway Management time until first effective Ventilation
Effective Ventilation within 90 Seconds required
90 sec
Secondary Outcomes (1)
Stomach inflation
60 sec
Study Arms (3)
Bag-Mask-Ventilation
ACTIVE COMPARATORBag-Valve Mask-Ventilation in 50 patients in general anesthesia
Laryngeal Mask Ventilation
ACTIVE COMPARATORLaryngeal Mask Ventilation in 50 patients in general anesthesia
Laryngeal Tube Ventilation
ACTIVE COMPARATORLaryngeal Tube Ventilation in 50 patients in general anesthesia
Interventions
Bag-Valve Mask-Ventilation
Ventilation
Ventilation
Eligibility Criteria
You may qualify if:
- ASA I-II
- \> 18 years old
- elective surgery in general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Krankenhaus Brunecklead
- Medical University Innsbruckcollaborator
Study Sites (1)
Krankenhaus Bruneck
Bruneck, Bolzano, 39031, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med univ.
Study Record Dates
First Submitted
October 12, 2011
First Posted
October 17, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 17, 2011
Record last verified: 2011-10