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

October 14, 2011 updated by: Gruber Elisabeth, Krankenhaus Bruneck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Bolzano
      • Bruneck, Bolzano, Italy, 39031
        • Krankenhaus Bruneck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bag-Mask-Ventilation
Bag-Valve Mask-Ventilation in 50 patients in general anesthesia
Device: Bag-Valve-Mask-Ventilation (Ambu Facemask)
Bag-Valve Mask-Ventilation
Other Names:
  • Ambu Facemask
Active Comparator: Laryngeal Mask Ventilation
Laryngeal Mask Ventilation in 50 patients in general anesthesia
Device: Laryngeal Mask (Laryngeal Mask Airway Supreme)
Ventilation
Other Names:
  • Laryngeal Mask Airway Supreme
Active Comparator: Laryngeal Tube Ventilation
Laryngeal Tube Ventilation in 50 patients in general anesthesia
Device: Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))
Ventilation
Other Names:
  • Laryngeal Tube LT-S-D (VBM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway Management time until first effective Ventilation
Time Frame: 90 sec
Effective Ventilation within 90 Seconds required
90 sec

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stomach inflation
Time Frame: 60 sec
Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask
60 sec

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Bruneck

Collaborators

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 14, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BLS VENT 2011/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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