LMA Placement Techniques and Airway in Children and Oropharyngeal Leak Pressure

NCT06174896 | Completed

• 1 other identifier: LMAPR1955
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Airway

Keywords

supraglottic airway device; pediatric population

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Blood pressure

  Preoperatively, one minute after the induction, fifth minute and before removed laryngeal mask.

• İnsertion time

  intraoperative period

• Number of placement attempts

  intraoperative period

• Need for optimization maneuvers

  intraoperative period

• Complications

  intraoperative and postoperative day 1.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Placement with standard technique

Procedure: Group 1

Group 2

ACTIVE COMPARATOR

Placement with direct laryngoscopy

Procedure: Group 2

Group 3

ACTIVE COMPARATOR

Placement with the aid of video laryngoscopy

Procedure: Group 3

Interventions

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.

Also known as: Standard technique

Group 1

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.

Also known as: Placement with direct laryngoscopy

Group 2

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

Also known as: Placement with the aid of video laryngoscopy

Group 3

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Between 5-40 kg
• ASA (American Society of Anesthesiologists) physical score I/II
• Cases undergoing elective surgery lasting less than 90 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 28870163 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.

  PMID: 34103833 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.

  PMID: 30611202 BACKGROUND

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yasemin Burcu Üstün, Prof. Dr

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Model Details: 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)'.

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: December 18, 2023
• Study Start: October 25, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 7, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

TU (1)