Laryngeal MasksNCT04229862
Effect of Head Elevation on LMA Insertion
A study testing Laryngeal mask airway insertion in people with Laryngeal Masks and Urinary Bladder Neoplasms, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Laryngeal Masks, Urinary Bladder Neoplasms
- What is being tested?
- Laryngeal mask airway insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Feb 2020to 5 May 2020
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled transurethral bladder tumor resection under general anesthesia
- 20-79 years of age
- American Society of Anesthesiologists physical status ≤3
- Patients who are voluntarily agreed to this clinical study
Who cannot join
- History of difficult airway
- Expected difficult airway by physical examination
- Unstable teeth or teeth loss
- Obesity (body mass index ≥ 30)
- Recent history of upper respiratory infection
- Patients who are not fasted or who are at risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial
The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.
Read the detailed description
The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.
- Conditions
- Laryngeal Masks, Urinary Bladder Neoplasms
- Being tested
- Laryngeal mask airway insertion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal mask airway insertionProcedure or surgery
Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection
| Study group | Role | What they receive |
|---|---|---|
| Evaluation with 14 cm high pillow | Experimental | When inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow. Receives: Procedure: Laryngeal mask airway insertion |
| Evaluation with 7 cm high pillow | Active comparator | When inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow. Receives: Procedure: Laryngeal mask airway insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
The rate of success at the first attempt of laryngeal mask airway insertion
Measured: Immediately after mask airway insertion
Secondary outcomes (7)
The percentage of glottic opening score
The percentage of glottic opening by fiberoptic view
Measured: Immediately after mask airway insertion
Laryngeal mask airway insertion-related patient satisfaction
A seven-point Likert scale
Measured: At postoperative 6 hours
Second attempt success rate
The rate of success at the second attempt of laryngeal mask airway insertion
Measured: Immediately after mask airway insertion
Third attempt success rate
The rate of success at the third attempt of laryngeal mask airway insertion
Measured: Immediately after mask airway insertion
Oropharyngeal leak pressure
Oropharyngeal leak pressure is measured as follows: After setting the expiratory valve to 30 cmH2O at a fixed gas flow rate of 3 L/min, the maximum inflation pressure is measured when a noise of gas leakage is heard in the oropharynx via a stethoscope.
Measured: Immediately after mask airway insertion
Reposition rate
The rate of reposition after laryngeal mask airway insertion when ventilation is ineffective or air leaks
Measured: After mask airway insertion (up to end of surgery)
Complications associated with laryngeal mask airway insertion
Complications related with laryngeal mask airway insertion such as cough, vomit, aspiration, regurgitation, bleeding, laryngospasm, and bronchospasm
Measured: Up to postoperative 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start14 Feb 2020
- Primary completion5 Apr 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229862
- Sponsor's protocol ID
- 2020-0020
- Status last verified
- May 2020
- First submitted
- 13 Jan 2020
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohta M. Head elevation beyond sniffing position - An aid to airway management. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):247-248. doi: 10.4103/joacp.JOACP_173_17. No abstract available.
PubMed 30104838Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
PubMed 26401265Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
PubMed 2917111Takenaka I, Aoyama K, Iwagaki T, Ishimura H, Kadoya T. The sniffing position provides greater occipito-atlanto-axial angulation than simple head extension: a radiological study. Can J Anaesth. 2007 Feb;54(2):129-33. doi: 10.1007/BF03022009.
PubMed 17272252Jun JH, Baik HJ, Kim JH, Kim YJ, Chang RN. Comparison of the ease of laryngeal mask airway ProSeal insertion and the fiberoptic scoring according to the head position and the presence of a difficult airway. Korean J Anesthesiol. 2011 Apr;60(4):244-9. doi: 10.4097/kjae.2011.60.4.244. Epub 2011 Apr 26.
PubMed 21602973Park JY, Yu J, Hong JH, Hwang JH, Kim YK. Head elevation and laryngeal mask airway Supreme insertion: A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Mar;65(3):343-350. doi: 10.1111/aas.13742. Epub 2020 Nov 28.
PubMed 33174199
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Elevation on LMA Supreme Insertion in Patients Undergoing Transurethral Resection of Bladder Tumor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04229862
- Acronym / sponsor ID
- 2020-0020
- Conditions
- Laryngeal Masks, Urinary Bladder Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 18 Jan 2020 (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 purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.
Detailed description
The purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evaluation with 14 cm high pillow | Experimental | Procedure: Laryngeal mask airway insertionWhen inserting laryngeal mask airway, head elevation is performed using a 14 cm high pillow. |
| Evaluation with 7 cm high pillow | Active comparator | Procedure: Laryngeal mask airway insertionWhen inserting laryngeal mask airway, head elevation is performed using a 7 cm high pillow. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are scheduled transurethral bladder tumor resection under general anesthesia
- 20-79 years of age
- American Society of Anesthesiologists physical status ≤3
- Patients who are voluntarily agreed to this clinical study
Key exclusion criteria (6 listed)
- History of difficult airway
- Expected difficult airway by physical examination
- Unstable teeth or teeth loss
- Obesity (body mass index ≥ 30)
- Recent history of upper respiratory infection
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 |
|---|---|---|
| Laryngeal mask airway insertionLaryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection | Procedure or surgery | Evaluation with 14 cm high pillow, Evaluation with 7 cm high pillow |
Primary outcome
First attempt success rate
Time frame: Immediately after mask airway insertion
The rate of success at the first attempt of laryngeal mask airway insertion
7 secondary outcomes
The percentage of glottic opening score
Time frame: Immediately after mask airway insertion
Laryngeal mask airway insertion-related patient satisfaction
Time frame: At postoperative 6 hours
Second attempt success rate
Time frame: Immediately after mask airway insertion
Third attempt success rate
Time frame: Immediately after mask airway insertion
Oropharyngeal leak pressure
Time frame: Immediately after mask airway insertion
Reposition rate
Time frame: After mask airway insertion (up to end of surgery)
Complications associated with laryngeal mask airway insertion
Time frame: Up to postoperative 3 days
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 29 May 2020.
- Background: PubMed 30104838Mohta M. Head elevation beyond sniffing position - An aid to airway management. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):247-248. doi: 10.4103/joacp.JOACP_173_17. No abstract available.
- Background: PubMed 26401265Katsiampoura AD, Killoran PV, Corso RM, Cai C, Hagberg CA, Cattano D. Laryngeal mask placement in a teaching institution: analysis of difficult placements. F1000Res. 2015 Apr 29;4:102. doi: 10.12688/f1000research.6415.1. eCollection 2015.
- Background: PubMed 2917111Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
- Background: PubMed 17272252Takenaka I, Aoyama K, Iwagaki T, Ishimura H, Kadoya T. The sniffing position provides greater occipito-atlanto-axial angulation than simple head extension: a radiological study. Can J Anaesth. 2007 Feb;54(2):129-33. doi: 10.1007/BF03022009.
- Background: PubMed 21602973Jun JH, Baik HJ, Kim JH, Kim YJ, Chang RN. Comparison of the ease of laryngeal mask airway ProSeal insertion and the fiberoptic scoring according to the head position and the presence of a difficult airway. Korean J Anesthesiol. 2011 Apr;60(4):244-9. doi: 10.4097/kjae.2011.60.4.244. Epub 2011 Apr 26.
- Derived from this study: PubMed 33174199Park JY, Yu J, Hong JH, Hwang JH, Kim YK. Head elevation and laryngeal mask airway Supreme insertion: A randomized controlled trial. Acta Anaesthesiol Scand. 2021 Mar;65(3):343-350. doi: 10.1111/aas.13742. Epub 2020 Nov 28.
- Individual participant dataSharing planned: No
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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.
Young-Kug Kim, MD, PhD principal investigator
Asan 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 Laryngeal mask airway insertion in people with Laryngeal Masks and Urinary Bladder Neoplasms, run by Asan Medical Center 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 4 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 29 May 2020. 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?
First attempt success rate (time frame: Immediately after mask airway insertion). 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 NCT04229862, which also lists 6 linked publications.
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 29 May 2020.