Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Head Positions to Open the Upper Airway

This study has been completed.
Information provided by:
Medical University Innsbruck Identifier:
First received: March 25, 2009
Last updated: September 29, 2009
Last verified: September 2009

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.

Condition Intervention
Cardiopulmonary Resuscitation
Procedure: Extension
Procedure: Neutral head position
Procedure: Anaesthesiologist's position

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Head Positions to Open the Upper Airway- a Pilot Study

Resource links provided by NLM:

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Head position angles [ Time Frame: Within 5 minutes after anaesthesia induction ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tidal volume [ Time Frame: Within 5 minutes after anaesthesia induction ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Neutralposition
Head placed in neutral position
Procedure: Neutral head position
After anaesthesia induction the head is placed in neutral position
Active Comparator: Extension
Head placed in extension
Procedure: Extension
After anaesthesia induction the head is placed in extension
Active Comparator: Anaesthesiologist's position
Head placed in position deemed optimal by an anaesthesiologist
Procedure: Anaesthesiologist's position
after anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00869648

Sponsors and Collaborators
Medical University Innsbruck
Principal Investigator: Peter Paal, MD, DESA Medical University Innsbruck
  More Information

No publications provided by Medical University Innsbruck

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paal Peter, MD, DESA, Medical University Innsbruck Identifier: NCT00869648     History of Changes
Other Study ID Numbers: UN3371
Study First Received: March 25, 2009
Last Updated: September 29, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University Innsbruck:
Ventilation processed this record on March 02, 2015