HealthyNCT00532636
Head Position Angles in Children
A study testing Ventilation in people with Healthy, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2006to Dec 2006
- 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA I and II children, 1-10 years of age
Who cannot join
- Facial deformity
- Pathological airway or cervical spine
- BMI>35
- History of gastric reflux
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Head Position Angles in Children to Open the Upper Airway
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. The head of children is randomly placed in different head positions by one investigator. A ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. This information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.
Read the detailed description
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 positions that make an open airway likely, and then extrapolate these angles to a scale that could be integrated into 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 reflecting neutral position and maximal extension in unconscious supine children in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway.
- Conditions
- Healthy
- Being tested
- Ventilation
- Keywords
- Airway, Airway obstruction, Mouth-to-mask resuscitation, Respiration artificial, Ventilation, Ventilation of an unprotected airway, Safety and efficiency of mask ventilation, Avoidance of stomach inflation
- Medical subject headings
- Airway Obstruction, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilationProcedure or surgery
Mask ventilation in neutral and head extension position
VentilationProcedure or surgery
Mask ventilation in neutral and head extension position
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Children 1-5 years of age Receives: Procedure: Ventilation |
| 2 | Active comparator | Children 6-10 years of age Receives: Procedure: Ventilation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
- Study startJan 2006
- Study completionDec 2006
Why it stopped: Recruitment completed
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 HealthyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Investigators
- Volker Wenzel, Prof., MD, MSc, Study chair, Dept. of Anesthesia and Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532636
- Sponsor's protocol ID
- AN2439
- Status last verified
- Mar 2009
- First submitted
- 18 Sep 2007
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paal P, Niederklapfer T, Keller C, von Goedecke A, Luckner G, Pehboeck D, Mitterlechner T, Herff H, Riccabona U, Wenzel V. Head-position angles in children for opening the upper airway. Resuscitation. 2010 Jun;81(6):676-8. doi: 10.1016/j.resuscitation.2010.01.022. Epub 2010 Mar 26.
PubMed 20346568
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Position Angles in Children to Open the Upper Airway
- ClinicalTrials.gov ID
- NCT00532636
- Acronym / sponsor ID
- AN2439
- Conditions
- Healthy
- Keywords
- Airway, Airway obstruction, Mouth-to-mask resuscitation, Respiration artificial, Ventilation, Ventilation of an unprotected airway, Safety and efficiency of mask ventilation, Avoidance of stomach inflation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 2007 (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.
Inexperienced rescuers may encounter severe problems in an unconscious patient in opening and maintaining an upper airway patent. Designing a ventilating device that could indicate how to open an upper airway correctly may be beneficial. The head of children is randomly placed in different head positions by one investigator. A ventilating mask is then pressed gently on the child's face followed by measurement of the head position angles and pulmonary function. This information could be utilised to optimise assisted ventilation of an unprotected upper airway in children.
Detailed description
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 positions that make an open airway likely, and then extrapolate these angles to a scale that could be integrated into 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 reflecting neutral position and maximal extension in unconscious supine children in a first step to design a ventilating device to optimise ventilation of an unprotected upper airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: VentilationChildren 1-5 years of age |
| 2 | Active comparator | Procedure: VentilationChildren 6-10 years of age |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA I and II children, 1-10 years of age
Key exclusion criteria (4 listed)
- Facial deformity
- Pathological airway or cervical spine
- BMI>35
- History of gastric reflux
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 |
|---|---|---|
| VentilationMask ventilation in neutral and head extension position | Procedure or surgery | 1 |
| VentilationMask ventilation in neutral and head extension position | Procedure or surgery | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Recruitment completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2009.
- Derived from this study: PubMed 20346568Paal P, Niederklapfer T, Keller C, von Goedecke A, Luckner G, Pehboeck D, Mitterlechner T, Herff H, Riccabona U, Wenzel V. Head-position angles in children for opening the upper airway. Resuscitation. 2010 Jun;81(6):676-8. doi: 10.1016/j.resuscitation.2010.01.022. Epub 2010 Mar 26.
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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.
Volker Wenzel, Prof., MD, MSc study chair
Dept. of Anesthesia and Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation in people with Healthy, run by Medical University Innsbruck at 1 site in Austria.
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: stopped early, as of the sponsor's last update on 26 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Recruitment completed). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00532636, 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 26 Mar 2009.