Multicenter Study of the Protector Laryngeal Mask

NCT03272776 | Completed

• 1 other identifier: MASKAPROTECTOR
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.

Conditions

Airway

Keywords

LMA Protector; Second Generation Laryngeal Masks; Airway; Dual Gastric Acces; Teleflex; Supraglottic Devices; Ambulatory Surgery

Outcome Measures

Primary Outcomes (1)

• Evaluate the number of attempts to insert of the LMA Protector

  Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)

  The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol

Secondary Outcomes (4)

• Blood pressure during insertion of LMA protect

  Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector

• Heart rate during insertion of LMA protect

  Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector

• BIS data

  Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA

• Oropharyngeal leak pressure of the LMA Protector

  The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted

Study Arms (1)

Protector Laryngeal Mask Airway

Patients undergoing anesthesia in which airway management includes a Protector Laryngeal Mask and fulfill the inclusion criteria of the study.

Device: Protector Laryngeal Mask airway

Interventions

Protector Laryngeal Mask airway DEVICE

Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.

Protector Laryngeal Mask Airway

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery procedures in any of the collaborating centers of the study that fulfill the inclusion and exclusion criteria described below.

You may qualify if:

• Surgery procedures usually performed with supraglottic devices.
• ASA physical status I-III patients
• Age 18-75
• Signed inform consent

You may not qualify if:

• Patients with known difficult airway
• Patients with predicted difficult airway
• Patients with increased risk of aspiration
• Patient refusal to participate in the study.

Sponsors & Collaborators

• Matilde Zaballos: lead
• Teleflex: collaborator

Study Sites (1)

Servicio de Anestesia, Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Related Publications (4)

• Brimacombe JR, editor. Laryngeal Mask Anesthesia. Principles and practice. 2nd Ed. Filadelfia. 2005.

  BACKGROUND

• Van Zundert AA, Skinner MW, Van Zundert TC, Luney SR, Pandit JJ. Value of knowing physical characteristics of the airway device before using it. Br J Anaesth. 2016 Jul;117(1):12-6. doi: 10.1093/bja/aew106. Epub 2016 May 4. No abstract available.

  PMID: 27147543 BACKGROUND

• Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, et al. Nuevas aportaciones de la mascarilla laríngea en cirugía ambulatoria. Contribución de la mascarilla laríngea Supreme. Cir May Amb 2011; 16(2): 60-6.

  BACKGROUND

• Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, Cordero Lorenzo JM, Izquierdo Villaroya B, Lafuente Ojeda N, M. López Gil M, Rodríguez Archilla A, Zaballos Bustingorri J Recomendaciones prácticas de uso de la mascarilla laríngea en Cirugía Ambulatoria. Cir May Amb 2008; 13: (1) 4-26.

  BACKGROUND

Study Officials

• Maite López-Gil

  Servicio de Anestesiología, Hospital General Universitario Gregorio Marañon

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 6, 2017
• Study Start: August 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)