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Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme

Comparison of Ventilation With Bag-Valve-Mask, Laryngeal Tube S-D and Laryngeal Mask Airway Supreme

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01452867
Enrollment
150
Registered
2011-10-17
Start date
2011-04-30
Completion date
2011-10-31
Last updated
2011-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Arrest

Keywords

Airway, Bag-Valve -Mask- Ventilation, Laryngeal Mask - Ventilation, Laryngeal Tube - Ventilation

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.

Interventions

DEVICEBag-Valve-Mask-Ventilation (Ambu Facemask)

Bag-Valve Mask-Ventilation

DEVICELaryngeal Mask (Laryngeal Mask Airway Supreme)

Ventilation

DEVICELaryngeal Tube (Laryngeal Tube LT-S-D (VBM))

Ventilation

Sponsors

Medical University Innsbruck
CollaboratorOTHER
Krankenhaus Bruneck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Airway Management time until first effective Ventilation90 secEffective Ventilation within 90 Seconds required

Secondary

MeasureTime frameDescription
Stomach inflation60 secStomach inflation during ventilation with mask, laryngeal tube an laryngeal mask

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026