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SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

NCT ID: NCT06245668

Last Updated: 2024-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2024-12-25

Brief Summary

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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.

Detailed Description

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Laryngeal masks are alternative airway devices commonly used in anesthesia, serving both spontaneously breathing and ventilated patients. LMA Supreme, a second-generation laryngeal mask, has been widely used in routine anesthesia practices and short-duration procedures in our clinic. The advantage of second-generation masks is the presence of gastric access pathways, allowing for additional decompression of the stomach. SaCoVLM™ Video Laryngeal Mask also features a gastric access pathway. Placement of laryngeal masks requires attention to the anatomical features of the airway. Unsuccessful placement of a laryngeal mask can lead to issues such as throat pain, hoarseness, difficulty swallowing, airway obstruction, or leakage, as well as an increase in intragastric pressure due to gastric distention.

Our research is a prospective, randomized, controlled method study.The aim in this study is to reveal most accurate placement technique and device to transfer this method to clinical applications. Patients will be evaluated in two groups.

Group 1: Placement with SaCoVLM™ video laryngeal mask Group 2: Placement of the LMA Supreme with standard technique

After LMA Supreme and SaCoVLM™ video laryngeal mask 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

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Anesthesia Airway

Keywords

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Supraglottic airway device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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SaCoVLM™ video laryngeal mask

SaCoVLM™ video laryngeal mask

Group Type ACTIVE_COMPARATOR

SaCoVLM™ video laryngeal mask

Intervention Type DEVICE

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

LMA Supreme

LMA Supreme

Group Type ACTIVE_COMPARATOR

LMA Supreme

Intervention Type 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.

Interventions

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SaCoVLM™ video laryngeal mask

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

Intervention Type DEVICE

LMA Supreme

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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BURHAN DOST

Assoc. Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Burhan Dost, Assoc. Prof.

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

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Ondokuz Mayis University

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28870163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28510747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36138363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23318811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36308611 (View on PubMed)

Other Identifiers

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VLMSM5455

Identifier Type: -

Identifier Source: org_study_id