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OpenTrials
Completed

NCT Number: NCT01452867

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Bruneck

Bruneck, Bolzano, 39031, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bag-Valve-Mask-Ventilation (Ambu Facemask)

Device

Bag-Valve Mask-Ventilation

Other names: Ambu Facemask

Laryngeal Mask (Laryngeal Mask Airway Supreme)

Device

Ventilation

Other names: Laryngeal Mask Airway Supreme

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

Device

Ventilation

Other names: Laryngeal Tube LT-S-D (VBM)

Primary outcomes

  1. Airway Management time until first effective Ventilation

    Time frame: 90 sec

    Effective Ventilation within 90 Seconds required

Secondary outcomes

  1. Stomach inflation

    Time frame: 60 sec

    Stomach inflation during ventilation with mask, laryngeal tube an laryngeal mask

Sponsors and collaborators

Lead sponsor

Krankenhaus Bruneck

Other

Collaborators

  • Medical University Innsbruck

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2011
Registry last updated
Oct 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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