Head Position Angles in Children

NCT ID: NCT00532636

Last Updated: 2009-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Children 1-5 years of age

Group Type: ACTIVE_COMPARATOR

Ventilation

Intervention Type: PROCEDURE

Mask ventilation in neutral and head extension position

Ventilation

Intervention Type: PROCEDURE

Mask ventilation in neutral and head extension position

2

Children 6-10 years of age

Group Type: ACTIVE_COMPARATOR

Ventilation

Intervention Type: PROCEDURE

Mask ventilation in neutral and head extension position

Interventions

Ventilation

Mask ventilation in neutral and head extension position

Intervention Type: PROCEDURE

Ventilation

Mask ventilation in neutral and head extension position

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Principal Investigators

Volker Wenzel, Prof., MD, MSc

Role: STUDY_CHAIR

Dept. of Anesthesia and Critical Care Medicine

Locations

Medical University Innsbruck

Innsbruck, , Austria

Countries

Austria

References

Paal P, Niederklapfer T, Keller C, von Goedecke A, Luckner G, Pehboeck D, Mitterlechner T, Herff H, Riccabona U, Wenzel V. Head-position angles in children for opening the upper airway. Resuscitation. 2010 Jun;81(6):676-8. doi: 10.1016/j.resuscitation.2010.01.022. Epub 2010 Mar 26.

Reference Type: DERIVED

PMID: 20346568 (View on PubMed)

Other Identifiers

AN2439

Identifier Type: -

Identifier Source: org_study_id