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

Not Applicable

Completed

• Conditions: Cardiopulmonary Arrest
• Interventions: Device: Bag-Valve-Mask-Ventilation (Ambu Facemask); Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM)); Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)

• Registration Number: NCT01452867
• Lead Sponsor: Krankenhaus Bruneck

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.

Study Timeline

• Study Start: 2011-04
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-14
• Last Update Submitted: 2011-10-14
• Study First Posted: 2011-10-17
• Last Update Posted: 2011-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bag-Mask-Ventilation	Bag-Valve-Mask-Ventilation (Ambu Facemask)	Bag-Valve Mask-Ventilation in 50 patients in general anesthesia
Laryngeal Tube Ventilation	Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))	Laryngeal Tube Ventilation in 50 patients in general anesthesia
Laryngeal Mask Ventilation	Laryngeal Mask (Laryngeal Mask Airway Supreme)	Laryngeal Mask Ventilation in 50 patients in general anesthesia

Primary Outcome Measures

Name	Time	Method
Airway Management time until first effective Ventilation	90 sec	Effective Ventilation within 90 Seconds required

Secondary Outcome Measures

Name	Time	Method
Stomach inflation	60 sec	Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask

Trial Locations

Locations (1)

Krankenhaus Bruneck; 🇮🇹 Bruneck, Bolzano, Italy