General AnesthesiaNCT03127683
The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children
A study testing Neutral position, Extension and Flexion in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated. This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Neutral position, Extension and Flexion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2017to 30 Nov 2017
- 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 Up to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children < 7 years old who scheduled for general anesthesia using supraglottic airway
Who cannot join
- Children who require tracheal intubation
- Emergency operation without NPO
- History of C-spine surgery or disease
- History of Esophageal disease or surgery
Trial locations and contacts
1 site in 1 country.
About this study
The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.
This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.
An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
- Conditions
- General Anesthesia
- Being tested
- Neutral position, Extension, Flexion, Rotation, Ambu AuraGain TM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral positionOther
Also called Neutral position of head and neck
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
ExtensionOther
Also called Head and neck extension
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
FlexionOther
Also called Head and neck flexion
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
RotationOther
Also called Head and neck rotation
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
Ambu AuraGain TMDevice
Single Use Laryngeal Mask Sterile
| Study group | Role | What they receive |
|---|---|---|
| AuraGain group | Experimental | An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order. Receives: Other: Neutral position; Other: Extension; Other: Flexion; Other: Rotation; Device: Ambu AuraGain TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min
Measured: 30 seconds after positioning of head and neck
Secondary outcomes (3)
Peak inspiratory pressure
peak airway pressure
Measured: 30 seconds after positioning of head and neck
Tidal volume
Expiratory tidal volume
Measured: 30 seconds after positioning of head and neck
Fiberopic bronchoscopic view
- No visible glottis 2. Visible glottis and anterior epiglottis 3. Visible glottis and posterior epiglottis 4. Only visible glottis
Measured: 30 seconds after positioning of head and neck
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start15 May 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127683
- Sponsor's protocol ID
- H1704-069-844
- Status last verified
- Nov 2017
- First submitted
- 20 Apr 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Head and Neck Position on Performance of Ambu AuraGainTM in Children
- ClinicalTrials.gov ID
- NCT03127683
- Acronym / sponsor ID
- H1704-069-844
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.
This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.
An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
| Arm | Type | Receives |
|---|---|---|
| AuraGain group | Experimental | Other: Neutral position, Other: Extension, Other: Flexion, Other: Rotation, Device: Ambu AuraGain TMAn AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg. The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children < 7 years old who scheduled for general anesthesia using supraglottic airway
Key exclusion criteria (4 listed)
- Children who require tracheal intubation
- Emergency operation without NPO
- History of C-spine surgery or disease
- History of Esophageal disease or surgery
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 |
|---|---|---|
| Neutral positionAlso: Neutral position of head and neckThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position | Other | AuraGain group |
| ExtensionAlso: Head and neck extensionThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position | Other | AuraGain group |
| FlexionAlso: Head and neck flexionThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position | Other | AuraGain group |
| RotationAlso: Head and neck rotationThe expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position | Other | AuraGain group |
| Ambu AuraGain TMSingle Use Laryngeal Mask Sterile | Device | AuraGain group |
Primary outcome
Oropharyngeal leak pressure
Time frame: 30 seconds after positioning of head and neck
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min
3 secondary outcomes
Peak inspiratory pressure
Time frame: 30 seconds after positioning of head and neck
Tidal volume
Time frame: 30 seconds after positioning of head and neck
Fiberopic bronchoscopic view
Time frame: 30 seconds after positioning of head and neck
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 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral position, Extension and Flexion in people with General Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
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 18 Apr 2018. 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 South Korea. 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 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?
Oropharyngeal leak pressure (time frame: 30 seconds after positioning of head and neck). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2018.