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Head Positions to Open the Upper Airway

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869648
First Posted: March 26, 2009
Last Update Posted: March 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck
  Purpose

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
Apnea Cardiopulmonary Resuscitation Procedure: Extension Procedure: Neutral head position Procedure: Anaesthesiologist's position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Head Positions to Open the Upper Airway- a Pilot Study

Further study details as provided by Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck:

Primary Outcome Measures:
  • Head position angles [ Time Frame: Within 5 minutes after anaesthesia induction ]

Secondary Outcome Measures:
  • Tidal volume [ Time Frame: Within 5 minutes after anaesthesia induction ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869648


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Paal, PD MD MBA EDAIC EDIC, PD MD MBA EDAIC EDIC, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00869648     History of Changes
Other Study ID Numbers: UN3371
First Submitted: March 25, 2009
First Posted: March 26, 2009
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck:
Airway
Anaesthesia
Resuscitation
Ventilation