Head Positions to Open the Upper Airway

NCT00869648 | Completed

• 1 other identifier: UN3371
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Apnea; Cardiopulmonary Resuscitation

Keywords

Airway; Anaesthesia; Resuscitation; Ventilation

Outcome Measures

Primary Outcomes (1)

• Head position angles

  Within 5 minutes after anaesthesia induction

Secondary Outcomes (1)

• Tidal volume

  Within 5 minutes after anaesthesia induction

Study Arms (3)

Neutralposition

ACTIVE COMPARATOR

Head placed in neutral position

Procedure: Neutral head position

Extension

ACTIVE COMPARATOR

Head placed in extension

Procedure: Extension

Anaesthesiologist's position

ACTIVE COMPARATOR

Head placed in position deemed optimal by an anaesthesiologist

Procedure: Anaesthesiologist's position

Interventions

Extension PROCEDURE

After anaesthesia induction the head is placed in extension

Extension

Neutral head position PROCEDURE

After anaesthesia induction the head is placed in neutral position

Neutralposition

Anaesthesiologist's position PROCEDURE

after anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist

Anaesthesiologist's position

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I and II

You may not qualify if:

• Cervical spine pathologies
• Peripheral nerve deficiencies
• Body mass index \>40kg/m2
• Obvious primary or secondary craniofacial abnormalities

Sponsors & Collaborators

• Medical University Innsbruck: lead

Related Publications (1)

• Mitterlechner T, Paal P, Kuehnelt-Leddhin L, Strasak AM, Putz G, Gravenstein N, von Goedecke A, Wenzel V. Head position angles to open the upper airway differ less with the head positioned on a support. Am J Emerg Med. 2013 Jan;31(1):80-5. doi: 10.1016/j.ajem.2012.06.007. Epub 2012 Sep 1.

  PMID: 22944550 DERIVED

MeSH Terms

Conditions

Apnea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Peter Paal, MD, DESA

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD MD MBA EDAIC EDIC

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 23, 2017

Record last verified: 2017-03