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

Krankenhaus Bruneck

Status: Completed

Conditions: Cardiopulmonary Arrest

Treatments: Device: Laryngeal Mask (Laryngeal Mask Airway Supreme); Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM)); Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)

Study type: Interventional

Funder types: Other

Identifiers

NCT01452867

BLS VENT 2011/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Bag-Mask-Ventilation

Active Comparator group

Description:

Bag-Valve Mask-Ventilation in 50 patients in general anesthesia

Treatment:

Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)

Laryngeal Mask Ventilation

Active Comparator group

Description:

Laryngeal Mask Ventilation in 50 patients in general anesthesia

Treatment:

Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)

Laryngeal Tube Ventilation

Active Comparator group

Description:

Laryngeal Tube Ventilation in 50 patients in general anesthesia

Treatment:

Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))