Clinical trial NCT06174896: LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure
Official title: Comparison of the Airway Sealing Pressures for Three Different Placement Techniques When Using Lma Proseal in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Airway
Keywords: supraglottic airway device
pediatric population
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)'.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: within 2-3 minutes after laryngeal mask insertion before start of surgery
Secondary outcomes:
measure: Blood pressure
timeFrame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
measure: İnsertion time
timeFrame: intraoperative period
measure: Number of placement attempts
timeFrame: intraoperative period
measure: Need for optimization maneuvers
timeFrame: intraoperative period
measure: Complications
timeFrame: intraoperative and postoperative day 1.
measure: Heart rate
timeFrame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
measure: Peripheral oxygen saturation
timeFrame: Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
Study officials:
affiliation: Ondokuz Mayıs University
name: Yasemin Burcu Üstün, Prof. Dr
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.