AnesthesiaNCT06174896
LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure
A study testing Group 1, Group 2 and Group 3 in people with Anesthesia and Airway, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Anesthesia, Airway
- What is being tested?
- Group 1, Group 2 and Group 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2023to 7 May 2024
- 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
- No healthy volunteers
- Child
Who may be able to join
- 1-10 years old
- Between 5-40 kg
- ASA (American Society of Anesthesiologists) physical score I/II
- Cases undergoing elective surgery lasting less than 90 minutes
Who cannot join
- Patients who are expected to have a difficult airway
- Those with potential regurgitation risk (severe GER, presence of hiatal hernia)
- Those who will undergo head and neck surgery, laparoscopic surgery
- Those who will undergo surgery in the prone position
- Emergency surgical interventions
- Those who need muscle relaxants
Show all 10Show fewer
- Presence of intraoral abscess, pharyngeal pathology
- Those who have had an upper or lower respiratory tract infection in the last 4 weeks
- History of allergy to the drugs to be used
- Failure of patients and their relatives to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Airway Sealing Pressures for Three Different Placement Techniques When Using Lma Proseal in Children
Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.
Read the detailed description
LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.
Our research is a prospective, randomized controlled method study.
Patients will be divided into 3 groups.
Group 1:(Standard technique)
Group 2:(Placement with direct laryngoscopy)
Group 3:(Placement with the aid of video laryngoscopy)
After LMA Proseal placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.
- Conditions
- Anesthesia, Airway
- Being tested
- Group 1, Group 2, Group 3
- Keywords
- supraglottic airway device, pediatric population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Procedure or surgery
Also called Standard technique
The LMA Proseal will be inserted directly by hand, without the use of any laryngoscope, as recommended in the instruction manual. The cuff will be gently guided along the hard palate where it is pushed into the hypopharynx and increased resistance is felt, and the cuff will be placed towards the hypopharynx.
Group 2Procedure or surgery
Also called Placement with direct laryngoscopy
Appropriately sized laryngoscope blade will be used and after the location of the epiglottis is determined, the tongue and epiglottis will be lifted forward. Then, LMA Proseal will be placed at the point where resistance is felt at a level where the proximal edge of the mask can be seen.
Group 3Procedure or surgery
Also called Placement with the aid of video laryngoscopy
After the video laryngoscope is placed with an appropriately sized blade, the location of the epiglottis and vocal cords will be determined and the LMA Proseal will be placed at the point where slight resistance is encountered after the epiglottis is lifted. proximal aspect of LMA
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Placement with standard technique Receives: Procedure: Group 1 |
| Group 2 | Active comparator | Placement with direct laryngoscopy Receives: Procedure: Group 2 |
| Group 3 | Active comparator | Placement with the aid of video laryngoscopy Receives: Procedure: Group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oropharyngeal leak pressure
Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 3 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure.
After successful insertion, lma proseal location will be evaluated with fiberoptic imaging.
Measured: within 2-3 minutes after laryngeal mask insertion before start of surgery
Secondary outcomes (7)
Blood pressure
Measure blood pressure in millimeter of mercury by non-invasive blood pressure.
Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
İnsertion time
LMA insertion time (time from LMA handling to first wave formation in capnography)
Measured: intraoperative period
Number of placement attempts
The number of attempts for optimal placement will be recorded
Measured: intraoperative period
Need for optimization maneuvers
It will be recorded whether additional maneuvering is performed for optimal placement. LMA rotation, jaw thrust, head extension, and flexion will be use as optimization maneuvers.
Measured: intraoperative period
Complications
İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal.
Measured: intraoperative and postoperative day 1.
Heart rate
Measure heart rate in beats per minute by electrocardiography monitor.
Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Peripheral oxygen saturation
Measure peripheral oxygen saturation per minute by pulse oximeter.
Measured: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start25 Oct 2023
- Primary completion1 Apr 2024
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Burcu Ustun, Ondokuz Mayıs University
- Investigators
- Yasemin Burcu Üstün, Prof. Dr, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174896
- Sponsor's protocol ID
- LMAPR1955
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.
PubMed 28870163Shyam T, Selvaraj V. Airway management using LMA-evaluation of three insertional techniques-a prospective randomised study. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):108-113. doi: 10.4103/joacp.JOACP_60_19. Epub 2021 Apr 10.
PubMed 34103833Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
PubMed 30611202
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Airway Sealing Pressures for Three Different Placement Techniques When Using Lma Proseal in Children
- ClinicalTrials.gov ID
- NCT06174896
- Acronym / sponsor ID
- LMAPR1955
- Conditions
- Anesthesia, Airway
- Keywords
- supraglottic airway device, pediatric population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 18 Dec 2023 (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.
Our study aimed to compare the manual placement, direct laryngoscopy and video laryngoscopy assisted placement techniques of LMA Proseal, a new generation laryngeal mask (LMA), and to find an effective placement technique that does not allow airway leakage in one go.
Detailed description
LMA is an airway device frequently used in pediatric anesthesia. It is preferred for short interventions because it is less invasive compared to intubation. However, problems such as not being fully seated, slipping, and leakage can be encountered during placement. Multiple attempts after unsuccessful placement may cause undesirable results such as edema and sore throat. The aim in this study is to reveal the most accurate placement technique and to transfer this method to clinical applications.
Our research is a prospective, randomized controlled method study.
Patients will be divided into 3 groups.
Group 1:(Standard technique)
Group 2:(Placement with direct laryngoscopy)
Group 3:(Placement with the aid of video laryngoscopy)
After LMA Proseal placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Group 1Placement with standard technique |
| Group 2 | Active comparator | Procedure: Group 2Placement with direct laryngoscopy |
| Group 3 | Active comparator | Procedure: Group 3Placement with the aid of video laryngoscopy |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-10 years old
- Between 5-40 kg
- ASA (American Society of Anesthesiologists) physical score I/II
- Cases undergoing elective surgery lasting less than 90 minutes
Key exclusion criteria (10 listed)
- Patients who are expected to have a difficult airway
- Those with potential regurgitation risk (severe GER, presence of hiatal hernia)
- Those who will undergo head and neck surgery, laparoscopic surgery
- Those who will undergo surgery in the prone position
- Emergency surgical interventions
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 |
|---|---|---|
| Group 1Also: Standard techniqueThe LMA Proseal will be inserted directly by hand, without the use of any laryngoscope, as recommended in the instruction manual. The cuff will be gently guided along the hard palate where it is pushed into the hypopharynx and increased resistance is felt, and the cuff will be placed towards the hypopharynx. | Procedure or surgery | Group 1 |
| Group 2Also: Placement with direct laryngoscopyAppropriately sized laryngoscope blade will be used and after the location of the epiglottis is determined, the tongue and epiglottis will be lifted forward. Then, LMA Proseal will be placed at the point where resistance is felt at a level where the proximal edge of the mask can be seen. | Procedure or surgery | Group 2 |
| Group 3Also: Placement with the aid of video laryngoscopyAfter the video laryngoscope is placed with an appropriately sized blade, the location of the epiglottis and vocal cords will be determined and the LMA Proseal will be placed at the point where slight resistance is encountered after the epiglottis is lifted. proximal aspect of LMA | Procedure or surgery | Group 3 |
Primary outcome
Oropharyngeal leak pressure
Time frame: within 2-3 minutes after laryngeal mask insertion before start of surgery
Oropharyngeal leak pressure (OLP) will be measured by closing the adjustable pressure limiting valve on the anesthesia machine. The fresh gas flow was adjusted to 3 L/min. When the APL (Adjustable pressure limiting) valve was closed and manually ventilated. The leak sound that occurs during ventilation will be auscultated. The first peak airway pressure at which the leak occurs will be recorded as the oropharyngeal leak pressure. After successful insertion, lma proseal location will be evaluated with fiberoptic imaging.
7 secondary outcomes
Blood pressure
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
İnsertion time
Time frame: intraoperative period
Number of placement attempts
Time frame: intraoperative period
Need for optimization maneuvers
Time frame: intraoperative period
Complications
Time frame: intraoperative and postoperative day 1.
Heart rate
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Peripheral oxygen saturation
Time frame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
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 4 Oct 2024.
- Background: PubMed 28870163Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.
- Background: PubMed 34103833Shyam T, Selvaraj V. Airway management using LMA-evaluation of three insertional techniques-a prospective randomised study. J Anaesthesiol Clin Pharmacol. 2021 Jan-Mar;37(1):108-113. doi: 10.4103/joacp.JOACP_60_19. Epub 2021 Apr 10.
- Background: PubMed 30611202Kim GW, Kim JY, Kim SJ, Moon YR, Park EJ, Park SY. Conditions for laryngeal mask airway placement in terms of oropharyngeal leak pressure: a comparison between blind insertion and laryngoscope-guided insertion. BMC Anesthesiol. 2019 Jan 5;19(1):4. doi: 10.1186/s12871-018-0674-6.
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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.
Yasemin Burcu Üstün, Prof. Dr study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1, Group 2 and Group 3 in people with Anesthesia and Airway, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 10 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 4 Oct 2024. 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 Turkey (Türkiye). 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 2-3 minutes after laryngeal mask insertion before start of surgery). 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 NCT06174896, which also lists 3 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 4 Oct 2024.