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Head Position Angles in Children
This study has been terminated.
Sponsored by: Medical University Innsbruck
Information provided by: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00532636
  Purpose

Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. The head of children is randomly placed in different head positions by one investigator. A ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. This information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.


Condition Intervention
Healthy
Procedure: Ventilation

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Crossover Assignment, Safety/Efficacy Study
Official Title: Head Position Angles in Children to Open the Upper Airway

Further study details as provided by Medical University Innsbruck:

Enrollment: 78
Study Start Date: January 2006
Study Completion Date: December 2006
Arms Assigned Interventions
1: Active Comparator
Children 1-5 years of age
Procedure: Ventilation
Mask ventilation in neutral and head extension position
Procedure: Ventilation
Mask ventilation in neutral and head extension position
2: Active Comparator
Children 6-10 years of age
Procedure: Ventilation
Mask ventilation in neutral and head extension position

Detailed Description:

Ventilation during basic life support improves survival in cardiac arrest patients significantly. Unfortunately, this is in contrast to the willingness of potential rescuers to perform mouth-to-mouth ventilation. For example, although healthcare professionals would perform mouth-to-mouth ventilation on a 4-year old drowned child in >90% of cases, this likelihood would decrease to ~10% in the case of a young male unconscious patient in a San Francisco public bus. Possibly, lay rescuers would perform assisted ventilation more often if a simple ventilation device were available. However, both the willingness to perform assisted ventilation plus the ability to open and to maintain the airway patent are necessary to ensure efficient ventilation in an unconscious patient with an unprotected upper airway.

Since retention of skills after basic life support classes are notoriously low, a resuscitation tool should incorporate self-explanatory features to improve applicability, and to provide built-in safety. Thus, an option could be to ensure an open airway by the use of a built-in indicator within a ventilating device to confirm correct head extension. One possible approach may be to determine head positions that make an open airway likely, and then extrapolate these angles to a scale that could be integrated into a ventilating device; however, safe head extension needs to be determined first to prevent harm. The purpose of this study is to determine head position angles reflecting neutral position and maximal extension in unconscious supine children in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway.

Eligibility criteria: ASA I and II patients; 1-10 years of age, male and female gender.

Exclusion criteria: Facial deformity, pathological airway or cervical spine, BMI>35, history of gastric reflux.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I and II children, 1-10 years of age

Exclusion Criteria:

  • Facial deformity
  • Pathological airway or cervical spine
  • BMI>35
  • History of gastric reflux
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532636

Locations
Austria
Medical University Innsbruck
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Investigators
Study Chair: Volker Wenzel, Prof., MD, MSc Dept. of Anesthesia and Critical Care Medicine
  More Information

Study ID Numbers: AN2439
Study First Received: September 18, 2007
Last Updated: September 19, 2007
ClinicalTrials.gov Identifier: NCT00532636  
Health Authority: Austria: Innsbruck Medical University Institutional Review Board

Keywords provided by Medical University Innsbruck:
Airway
Airway obstruction
Mouth-to-mask resuscitation
Respiration artificial
Ventilation
Ventilation of an unprotected airway
Safety and efficiency of mask ventilation
Avoidance of stomach inflation

Study placed in the following topic categories:
Airway Obstruction
Healthy

ClinicalTrials.gov processed this record on January 16, 2009