SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

NCT06245668 | Completed

• 1 other identifier: VLMSM5455
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Our study aimed to compare two different laryngeal masks, SaCoVLM™ Video Laryngeal Mask and blind placement with LMA Supreme, in adult patients undergoing short elective surgeries. The aim is to optimize the use of commonly used laryngeal masks in clinical practice and examine the differences in oropharyngeal leak pressures.

Conditions

Anesthesia; Airway

Keywords

Supraglottic airway device

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 4 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, laryngeal mask location will be evaluated with fiberoptic imaging.

  Immediately after the laryngeal mask is placed, before start of surgery

Secondary Outcomes (8)

• Assessment of Glottis Visualization Scores

  Intraoperative period after the LMA insertion

• Peak Inspratuar Pressure and Plato Pressure

  Intraoperative period

• Insertion time

  Procedure (Time from LMA handling to first wave formation in capnography, assessed from the initiation of LMA handling until the detection of the first capnography wave.)

• Number of attempts to place the device

  Intraoperative period

• Blood pressure

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

Study Arms (2)

SaCoVLM™ video laryngeal mask

ACTIVE COMPARATOR

SaCoVLM™ video laryngeal mask

Device: SaCoVLM™ video laryngeal mask

LMA Supreme

ACTIVE COMPARATOR

LMA Supreme

Device: LMA Supreme

Interventions

SaCoVLM™ video laryngeal mask DEVICE

The SaCoVLM™ video laryngeal mask will be placed directly into the hypopharyngeal space until resistance is felt, following the recommended instructions for use.

SaCoVLM™ video laryngeal mask

LMA Supreme DEVICE

The LMA Supreme will be inserted directly by hand and placed into the hypopharyngeal space until resistance is felt, as per the recommended instructions for use.

LMA Supreme

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• BMI \< 35 kg/m2
• ASA (American Society of Anesthesiologists) physical score I/II
• Elective surgeries lasting less than 90 minutes

You may not qualify if:

• Patients who are expected to have a difficult airway
• Those with potential risk of regurgitation (severe reflux, 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 requiring muscle relaxants
• Presence of oral abscess, pharyngeal pathology
• Those who have had an upper or lower respiratory tract infection in the last 4 weeks
• History of allergy to medications used
• Failure to obtain the consent of patients or their families

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, 55270, Turkey (Türkiye)

Location

Related Publications (5)

• 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

• Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.

  PMID: 28510747 BACKGROUND

• Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. Comparison of SaCoVLM video laryngeal mask-guided intubation and i-gel combined with flexible bronchoscopy-guided intubation in airway management during general anesthesia: a non-inferiority study. BMC Anesthesiol. 2022 Sep 22;22(1):302. doi: 10.1186/s12871-022-01843-x.

  PMID: 36138363 BACKGROUND

• Belena JM, Nunez M, Anta D, Carnero M, Gracia JL, Ayala JL, Alvarez R, Yuste J. Comparison of Laryngeal Mask Airway Supreme and Laryngeal Mask Airway Proseal with respect to oropharyngeal leak pressure during laparoscopic cholecystectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Mar;30(3):119-23. doi: 10.1097/EJA.0b013e32835aba6a.

  PMID: 23318811 BACKGROUND

• Yan CL, Zhang YQ, Chen Y, Qv ZY, Zuo MZ. To compare the influence of blind insertion and up-down optimized glottic exposure manoeuvre on oropharyngeal leak pressure using SaCoVLM video laryngeal mask among patients undergoing general anesthesia. J Clin Monit Comput. 2023 Apr;37(2):593-598. doi: 10.1007/s10877-022-00930-1. Epub 2022 Oct 29.

  PMID: 36308611 BACKGROUND

Study Officials

• Burhan Dost, Assoc. Prof.

  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 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: Assoc. 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: January 29, 2024
• First Posted: February 7, 2024
• Study Start: April 1, 2024
• Primary Completion: October 26, 2024
• Study Completion: December 25, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

TU (1)