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

NCT ID: NCT01452867

Last Updated: 2011-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Cardiopulmonary Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bag-Mask-Ventilation

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

Group Type ACTIVE_COMPARATOR

Bag-Valve-Mask-Ventilation (Ambu Facemask)

Intervention Type DEVICE

Bag-Valve Mask-Ventilation

Laryngeal Mask Ventilation

Laryngeal Mask Ventilation in 50 patients in general anesthesia

Group Type ACTIVE_COMPARATOR

Laryngeal Mask (Laryngeal Mask Airway Supreme)

Intervention Type DEVICE

Ventilation

Laryngeal Tube Ventilation

Laryngeal Tube Ventilation in 50 patients in general anesthesia

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Ventilation

Interventions

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Bag-Valve-Mask-Ventilation (Ambu Facemask)

Bag-Valve Mask-Ventilation

Intervention Type DEVICE

Laryngeal Mask (Laryngeal Mask Airway Supreme)

Ventilation

Intervention Type DEVICE

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

Ventilation

Intervention Type DEVICE

Other Intervention Names

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Ambu Facemask Laryngeal Mask Airway Supreme Laryngeal Tube LT-S-D (VBM)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role collaborator

Krankenhaus Bruneck

OTHER

Sponsor Role lead

Responsible Party

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Gruber Elisabeth

Dr. med univ.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Krankenhaus Bruneck

Bruneck, Bolzano, Italy

Site Status

Countries

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Italy

Other Identifiers

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BLS VENT 2011/04

Identifier Type: -

Identifier Source: org_study_id