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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Placement with standard technique |
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| Group 2 | Active Comparator | Placement with direct laryngoscopy |
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| Group 3 | Active Comparator | Placement with the aid of video laryngoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within 2-3 minutes after laryngeal mask insertion before start of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Measure blood pressure in millimeter of mercury by non-invasive blood pressure. | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. |
| İnsertion time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yasemin Burcu Üstün, Prof. Dr | Ondokuz Mayıs University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ondokuz Mayis University | Samsun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28870163 | Background | 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. | |
| 34103833 | Background | Shyam 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. |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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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)'.
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Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1:1 ratio.
A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the methods which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.
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| Group 2 | Procedure | 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. |
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| Group 3 | Procedure | 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 |
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LMA insertion time (time from LMA handling to first wave formation in capnography)
| intraoperative period |
| Number of placement attempts | The number of attempts for optimal placement will be recorded | 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. | intraoperative period |
| Complications | İnvestigate the existence of complications that may be encountered in the routine after LMA placement and removal. | intraoperative and postoperative day 1. |
| Heart rate | Measure heart rate in beats per minute by electrocardiography monitor. | 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. | Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask. |
| 30611202 | Background | Kim 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. |