Head Positions to Open the Upper Airway
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
- Head position angles [ Time Frame: Within 5 minutes after anaesthesia induction ] [ Designated as safety issue: Yes ]
- 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
|
Eligibility| 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
More Information
No publications provided by Medical University Innsbruck
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Paal Peter, MD, DESA, Medical University Innsbruck |
| ClinicalTrials.gov 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:
|
Airway Anaesthesia Resuscitation Ventilation |
Additional relevant MeSH terms:
|
Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013