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

Cardiopulmonary Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452867
• Other study ID #: BLS VENT 2011/04
• Status: Completed
• Phase: N/A
• First received: October 12, 2011
• Last updated: October 14, 2011
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Krankenhaus Bruneck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board General Hospital: Bozen Italy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
Italy	Krankenhaus Bruneck	Bruneck	Bolzano

Sponsors (2)

Lead Sponsor	Collaborator
Krankenhaus Bruneck	Medical University Innsbruck

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway Management time until first effective Ventilation	Effective Ventilation within 90 Seconds required	90 sec	No
Secondary	Stomach inflation	Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask	60 sec	No