ApneaNCT00869648
Head Positions to Open the Upper Airway
A study testing Extension, Neutral head position and Anaesthesiologist's position in people with Apnea and Cardiopulmonary Resuscitation, run by Medical University Innsbruck.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea, Cardiopulmonary Resuscitation
- What is being tested?
- Extension, Neutral head position and Anaesthesiologist's position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I and II
Who cannot join
- Cervical spine pathologies
- Peripheral nerve deficiencies
- Body mass index >40kg/m2
- Obvious primary or secondary craniofacial abnormalities
About this study
Official title: Head Positions to Open the Upper Airway- a Pilot Study
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.
Read more
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
- Being tested
- Extension, Neutral head position, Anaesthesiologist's position
- Keywords
- Airway, Anaesthesia, Resuscitation, Ventilation
- Medical subject headings
- Apnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExtensionProcedure or surgery
After anaesthesia induction the head is placed in extension
Neutral head positionProcedure or surgery
After anaesthesia induction the head is placed in neutral position
Anaesthesiologist's positionProcedure or surgery
after anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist
| Study group | Role | What they receive |
|---|---|---|
| Neutralposition | Active comparator | Head placed in neutral position Receives: Procedure: Neutral head position |
| Extension | Active comparator | Head placed in extension Receives: Procedure: Extension |
| Anaesthesiologist's position | Active comparator | Head placed in position deemed optimal by an anaesthesiologist Receives: Procedure: Anaesthesiologist's position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head position angles
Measured: Within 5 minutes after anaesthesia induction
Secondary outcomes (1)
Tidal volume
Measured: Within 5 minutes after anaesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Paal, PD MD MBA EDAIC EDIC, Medical University Innsbruck
- Investigators
- Peter Paal, MD, DESA, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869648
- Sponsor's protocol ID
- UN3371
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2009
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22944550
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Positions to Open the Upper Airway- a Pilot Study
- ClinicalTrials.gov ID
- NCT00869648
- Acronym / sponsor ID
- UN3371
- Conditions
- Apnea, Cardiopulmonary Resuscitation
- Keywords
- Airway, Anaesthesia, Resuscitation, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neutralposition | Active comparator | Procedure: Neutral head positionHead placed in neutral position |
| Extension | Active comparator | Procedure: ExtensionHead placed in extension |
| Anaesthesiologist's position | Active comparator | Procedure: Anaesthesiologist's positionHead placed in position deemed optimal by an anaesthesiologist |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I and II
Key exclusion criteria (4 listed)
- Cervical spine pathologies
- Peripheral nerve deficiencies
- Body mass index >40kg/m2
- Obvious primary or secondary craniofacial abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExtensionAfter anaesthesia induction the head is placed in extension | Procedure or surgery | Extension |
| Neutral head positionAfter anaesthesia induction the head is placed in neutral position | Procedure or surgery | Neutralposition |
| Anaesthesiologist's positionafter anaesthesia induction the head is placed in a position deemed optimal by the anaesthesiologist | Procedure or surgery | Anaesthesiologist's position |
Primary outcome
Head position angles
Time frame: Within 5 minutes after anaesthesia induction
1 secondary outcome
Tidal volume
Time frame: Within 5 minutes after anaesthesia induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 22944550Mitterlechner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Paal, MD, DESA principal investigator
Medical University Innsbruck
Questions about this trial
What is this clinical trial studying?
A study testing Extension, Neutral head position and Anaesthesiologist's position in people with Apnea and Cardiopulmonary Resuscitation, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head position angles (time frame: Within 5 minutes after anaesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.