Head Position Angles in Children

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Head Position Angles in Children to Open the Upper Airway

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Ventilation
* Procedure: Ventilation


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Children 1-5 years of age | Procedure: Ventilation<br>* Mask ventilation in neutral and head extension position<br>Procedure: Ventilation<br>* Mask ventilation in neutral and head extension position<br>|
| Active Comparator: 2<br>Children 6-10 years of age | Procedure: Ventilation<br>* Mask ventilation in neutral and head extension position<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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