Head Positions to Open the Upper Airway

Apnea Clinical Trial

Official title:

Head Positions to Open the Upper Airway- a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869648
• Other study ID #: UN3371
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: March 21, 2017
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: March 2017
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 position angles that make an open airway likely, and integrate these angles into a scale on 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 and ventilation parameters reflecting neutral position, maximal extension and a position deemed optimal by an anaesthesiologist in patients undergoing anaesthesia induction for elective surgery in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway. The investigators will ventilate 30 patients with a pillow under the head simulating ventilation in the operating theater, and 30 patients without a pillow under the head simulating ventilation during cardiopulmonary resuscitation.

Dentures will not be removed during assessment. After anaesthesia induction the head will be consecutively flexed in the three positions and measurements performed. Afterwards, general anaesthesia and surgery will ensue. The health risk for this extra minutes of mask ventilation is minimal.

The null hypothesis is that there will be no differences in head position angles and ventilation parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I and II

Exclusion Criteria:

• Cervical spine pathologies

• Peripheral nerve deficiencies

• Body mass index >40kg/m2

• Obvious primary or secondary craniofacial abnormalities

Related Conditions & MeSH terms

• Apnea
• Cardiopulmonary Resuscitation

Intervention

Procedure:
• Extension
After anaesthesia induction the head is placed in extension
• Neutral head position
After anaesthesia induction the head is placed in neutral position
• Anaesthesiologist's position
after anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Head position angles		Within 5 minutes after anaesthesia induction
Secondary	Tidal volume		Within 5 minutes after anaesthesia induction