Head Positions to Open the Upper Airway
|ClinicalTrials.gov Identifier: NCT00869648|
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : March 23, 2017
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 or disease||Intervention/treatment|
|Apnea Cardiopulmonary Resuscitation||Procedure: Extension Procedure: Neutral head position Procedure: Anaesthesiologist's position|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Head Positions to Open the Upper Airway- a Pilot Study|
|Study Start Date :||April 2009|
|Primary Completion Date :||July 2009|
|Study Completion Date :||August 2009|
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
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
- Head position angles [ Time Frame: Within 5 minutes after anaesthesia induction ]
- Tidal volume [ Time Frame: Within 5 minutes after anaesthesia induction ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869648
|Principal Investigator:||Peter Paal, MD, DESA||Medical University Innsbruck|