General AnesthesiaNCT02402387
The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway
A study testing Neutral head position, Flexed head position and Extended head position in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Neutral head position, Flexed head position and Extended head position
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2015to 27 Aug 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia
Who cannot join
- anticipated difficult intubation
- body mass index more than 30 km/m2
- history of gastroesophageal reflux disease
- history of esophageal operation
- cervical spine disease
- mass in the oral cavity or neck
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions.
- Conditions
- General Anesthesia
- Being tested
- Neutral head position, Flexed head position, Extended head position, Rotated head position, Air-Q SP Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral head positionProcedure or surgery
Flexed head positionProcedure or surgery
Extended head positionProcedure or surgery
Rotated head positionProcedure or surgery
Air-Q SP AirwayDevice
| Study group | Role | What they receive |
|---|---|---|
| Neutral | Active comparator | The patient's head will be in neutral position. Receives: Procedure: Neutral head position; Device: Air-Q SP Airway |
| Flexed | Experimental | The patient's head will be flexed. Receives: Procedure: Flexed head position; Device: Air-Q SP Airway |
| Extended | Experimental | The patient's head will be extended. Receives: Procedure: Extended head position; Device: Air-Q SP Airway |
| Rotated | Experimental | The patient's head will be rotated. Receives: Procedure: Rotated head position; Device: Air-Q SP Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
The oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 40 cmH2O
Measured: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Secondary outcomes (2)
Peak airway pressure
Measured: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Fiberoptic bronchoscope grade
Measured: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start12 May 2015
- Primary completion27 Aug 2015
- Study completion27 Aug 2015
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 General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402387
- Sponsor's protocol ID
- 4-2015-0050
- Status last verified
- Jan 2017
- First submitted
- 24 Mar 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim HJ, Lee K, Bai S, Kim MH, Oh E, Yoo YC. Influence of head and neck position on ventilation using the air-Q(R) SP airway in anaesthetized paralysed patients: a prospective randomized crossover study. Br J Anaesth. 2017 Mar 1;118(3):452-457. doi: 10.1093/bja/aew448.
PubMed 28203730
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Head and Neck Position on the Oropharyngeal Leak Pressure Using Air-Q SP Airway
- ClinicalTrials.gov ID
- NCT02402387
- Acronym / sponsor ID
- 4-2015-0050
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 May 2015 (actual)
- Primary completion
- 27 Aug 2015 (actual)
- Study completion
- 27 Aug 2015 (actual)
- First posted
- 30 Mar 2015 (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.
The purpose of this study is to investigate the changes of the oropharyngeal leak pressure of the air-Q self-pressurizing masked laryngeal airway in the different head and neck positions. Moreover, the adequacy of ventilation will be assessed in the different head and neck positions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Neutral | Active comparator | Procedure: Neutral head position, Device: Air-Q SP AirwayThe patient's head will be in neutral position. |
| Flexed | Experimental | Procedure: Flexed head position, Device: Air-Q SP AirwayThe patient's head will be flexed. |
| Extended | Experimental | Procedure: Extended head position, Device: Air-Q SP AirwayThe patient's head will be extended. |
| Rotated | Experimental | Procedure: Rotated head position, Device: Air-Q SP AirwayThe patient's head will be rotated. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia
Key exclusion criteria (6 listed)
- anticipated difficult intubation
- body mass index more than 30 km/m2
- history of gastroesophageal reflux disease
- history of esophageal operation
- cervical spine disease
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 head position | Procedure or surgery | Neutral |
| Flexed head position | Procedure or surgery | Flexed |
| Extended head position | Procedure or surgery | Extended |
| Rotated head position | Procedure or surgery | Rotated |
| Air-Q SP Airway | Device | Extended, Flexed, Neutral, Rotated |
Primary outcome
Oropharyngeal leak pressure
Time frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
The oropharyngeal leak pressure was measured by closing the expiratory valve of the circle system at fixed O2 flow 3L/min and 40 cmH2O
2 secondary outcomes
Peak airway pressure
Time frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
Fiberoptic bronchoscope grade
Time frame: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway
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 25 Jan 2017.
- Derived from this study: PubMed 28203730Kim HJ, Lee K, Bai S, Kim MH, Oh E, Yoo YC. Influence of head and neck position on ventilation using the air-Q(R) SP airway in anaesthetized paralysed patients: a prospective randomized crossover study. Br J Anaesth. 2017 Mar 1;118(3):452-457. doi: 10.1093/bja/aew448.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 head position, Flexed head position and Extended head position in people with General Anesthesia, run by Yonsei University 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 6 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 25 Jan 2017. 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: Within 5 minutes after the insertion of the air-q self-pressurizing masked laryngeal airway). 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 NCT02402387, 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 25 Jan 2017.