Head Position Angles in Children

This study has been terminated.
(Recruitment completed)
Sponsor:
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00532636
First received: September 18, 2007
Last updated: March 25, 2009
Last verified: March 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Head Position Angles in Children to Open the Upper Airway

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Enrollment: 78
Study Start Date: January 2006
Study Completion Date: December 2006
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Medical University Innsbruck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00532636     History of Changes
Other Study ID Numbers: AN2439
Study First Received: September 18, 2007
Last Updated: March 25, 2009
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

ClinicalTrials.gov processed this record on October 23, 2014