AnesthesiaNCT02058030
The Influence of Degree of Head Elevation on Insertion Success for ProSeal Laryngeal Mask Airway Insertion
A study testing Insertion of ProSeal laryngeal mask airway in people with Anesthesia, run by National Medical Center, Seoul at 1 site in South Korea.
Trial summary
Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion Methods This prospective randomized, controlled study included 80 adult patients . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Insertion of ProSeal laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Dec 2014
- 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
- American Society of Anesthesiologists physical status 1-2
- scheduled for minor surgery in the supine position were enrolled
Who cannot join
- cardiorespiratory disease patients
- patients were at risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients
Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion
Methods
- This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.
Read the detailed description
Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.
There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.
However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.
- Conditions
- Anesthesia
- Being tested
- Insertion of ProSeal laryngeal mask airway
- Keywords
- ProSeal laryngeal mask airway, Insertion success, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of ProSeal laryngeal mask airwayDevice
The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position.
The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed
| Study group | Role | What they receive |
|---|---|---|
| 3cm head elevation | Other | Insertion of ProSeal laryngeal mask airway Receives: Device: Insertion of ProSeal laryngeal mask airway |
| 6cm head elevation | Active comparator | Insertion of ProSeal laryngeal mask airway Receives: Device: Insertion of ProSeal laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion success rate
Measured: 2013.11 - 2014.12
Secondary outcomes (1)
complication
Number of participants with blood on the surface of the cuff, postoperative sore throat and hoarseness as indices of complications.
Measured: 2013.11- 2014.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionDec 2014
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 AnesthesiaStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Center, Seoul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Hoon Kim, National Medical Center, Seoul
- Investigators
- Mija Yun, MD, PhD, Study chair, National medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058030
- Sponsor's protocol ID
- phdkim1
- Status last verified
- Aug 2015
- First submitted
- 8 Oct 2013
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yun MJ, Hwang JW, Kim SH, Hong HJ, Jeon YT, Park HP. Head elevation by 3 vs. 6 cm in ProSeal laryngeal mask airway insertion: a randomized controlled trial. BMC Anesthesiol. 2016 Aug 5;16(1):57. doi: 10.1186/s12871-016-0220-3.
PubMed 27494933
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 3 cm of Head Elevation Provides Higher Insertion Success Than do the 6 cm of it for ProSeal Laryngeal Mask Airway Insertion in Adult Patients
- ClinicalTrials.gov ID
- NCT02058030
- Acronym / sponsor ID
- phdkim1
- Conditions
- Anesthesia
- Keywords
- ProSeal laryngeal mask airway, Insertion success, complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Medical Center, SeoulUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Feb 2014 (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.
Background - The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSealTM laryngeal mask airway insertion
Methods
- This prospective randomized, controlled study included 80 adult patients . In the 3 cm (n=40) or 6 cm group (n=40), the PLMA was inserted while the head is placed on the 3 cm or 6 cm height of pillow. The success rate at first and second attempt, insertion time, blood staining on cuff, sore throat and hoarseness were assessed.
Detailed description
Background: The "sniffing position" (i.e., the neck flexed and head extended by means of a pillow) eases tracheal intubation because the three axes, namely, the axis of the mouth, the pharyngeal axis and the laryngeal axis, are put in almost a straight line. The benefit of the sniffing position that align three axis could possibly be applicable when the ProSeal LMA is inserted. For the endotracheal intubation, it has been recommended to elevate the patient's head 8 to 10 cm with pads under the occiput (shoulder remaining on the table) and extend the head at the atlanto-occipital joint to align the oral, pharyngeal, and laryngeal axes such that the passage and line of vision from the lips to the glottic opening are most nearly a straight line.
There have been several clinical studies about the effect of head and neck position including neutral, flexion or extension on the ease of LMA insertion.
However, it has not been much recommended or investigated about the influence of head elevation on the insertion success of PLMA until now. The purpose of the present study is to evaluate the success and pharyngeal trauma when 3 or 6 cm height of pillow is used for the ProSeal laryngeal mask airway insertion in adult patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3cm head elevation | Other | Device: Insertion of ProSeal laryngeal mask airwayInsertion of ProSeal laryngeal mask airway |
| 6cm head elevation | Active comparator | Device: Insertion of ProSeal laryngeal mask airwayInsertion of ProSeal laryngeal mask airway |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1-2
- scheduled for minor surgery in the supine position were enrolled
Key exclusion criteria (2 listed)
- cardiorespiratory disease patients
- patients were at risk of aspiration
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 |
|---|---|---|
| Insertion of ProSeal laryngeal mask airwayThe patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position. The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed | Device | 3cm head elevation, 6cm head elevation |
Primary outcome
insertion success rate
Time frame: 2013.11 - 2014.12
1 secondary outcome
complication
Time frame: 2013.11- 2014.12
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 7 Aug 2015.
- Derived from this study: PubMed 27494933Yun MJ, Hwang JW, Kim SH, Hong HJ, Jeon YT, Park HP. Head elevation by 3 vs. 6 cm in ProSeal laryngeal mask airway insertion: a randomized controlled trial. BMC Anesthesiol. 2016 Aug 5;16(1):57. doi: 10.1186/s12871-016-0220-3.
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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.
Mija Yun, MD, PhD study chair
National medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of ProSeal laryngeal mask airway in people with Anesthesia, run by National Medical Center, Seoul 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 2 inclusion and 2 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 7 Aug 2015. 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?
insertion success rate (time frame: 2013.11 - 2014.12). 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 NCT02058030, 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 7 Aug 2015.