Head Position Angles in Children

Healthy Clinical Trial

Official title:

Head Position Angles in Children to Open the Upper Airway

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00532636
• Other study ID #: AN2439
• Status: Terminated
• Phase: N/A
• First received: September 18, 2007
• Last updated: March 25, 2009
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2009
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Innsbruck Medical University Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• Ventilation
Mask ventilation in neutral and head extension position
• Ventilation
Mask ventilation in neutral and head extension position

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria,