The Effect of Placement of Proseal Laryngeal Mask Airway With C-Mac Videolaryngoscopy

Comparison of C-MAC Videolaryngoscopy-guided Proseal Laryngeal Mask Airway Placement vs Conventional Blind Technique: a Prospective Randomized Study

The ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. The manufacturer recommends inserting the ProSealTM LMA using digital manipulation or with an introducer tool, but both these techniques have lower success rates than the classic LMA.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Laryngeal Masks; Videolaryngoscopy
• Intervention / Treatment: Device: C-MAC videolaryngoscope; Device: Blind

Detailed Description

Airway management is one of the cornerstones for modern anaesthesia and is vital for all patients undergoing general anaesthesia. Supraglottic airway devices (SADs) are increasingly used for managing airways.

The ProSeal laryngeal mask airway (PLMA) (Laryngeal Mask Company, San Diego, CA, USA) is a supraglottic airway device with a larger cuff than the Classic laryngeal mask airway to produce a better seal. The PLMA is also equipped with a drainage tube to permit insertion of a gastric tube and evacuation of gastric content. The presence of the drainage tube reduces the risk of aspiration, which is the major concern of the Classic laryngeal mask airway, especially when the device is used with positive pressure ventilation. While a dedicated introducer (commonly known as an ''introducer tool'') is recommended by the manufacturer to facilitate insertion of the PLMA, difficulties can still be encountered during insertion. The PLMA insertion success rate at first attempt has been reported as 82-87%, which is lower than the insertion success rate of the Classic laryngeal mask airway.

Malpositioning of the PLMA is common in clinical practice because its soft cuff can fold over onto itself. Malpositioning of the device can result in severe leaks and even obstruction of the airway, with potentially negative outcomes for the patient. Although the incidence of complications(e.g. airway trauma, obstruction, regurgitation, gastric distension with mechanical ventilation) is likely to be higher with an incorrectly placed SAD, clinical airway obstruction can result from other causes, such as laryngospasm and transient closure of the glottis.

Many methods have been proposed to facilitate insertion of PLMAs, including insertion of a gastric tube,a suction catheter, or a gum elastic bougie into the drainage tube. These techniques help to prevent the PLMA soft cuff from folding over and help to decrease the incidence of malpositioning.

This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44090
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18- 65 years
• Undergoing short surgical prcedures with general anesthesia using a PLMA
• American Society of Anesthesiology score I-II

Exclusion Criteria:

• Anticipated difficult airway
• Risk of aspiration
• Patients who refused written informed consent forms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C-MAC Videolaryngoscope; C-MAC Videolaryngoscope: An intubating device that is used for endotracheal intubation. Proseal laryngeal mask airway will be inserted with C-MAC Videolaryngoscope	Device: C-MAC videolaryngoscope; An intubating device that is used for endotracheal intubation. PLMA will inserted by anesthesiologist with C-MAC videolaryngoscope.
Active Comparator: Blind; Proseal laryngeal mask airway will be inserted with digital finger	Device: Blind; PLMA will inserted by anesthesiologist with digital finger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	The PLMA will inserted into hypopharynx, the cuff will inflated with an appropraite volume of air. An effective airway will judged by a square wave on capnography.	From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion time	Insertion time was the time between picking up the PLMA and successful placement	From inserted PLMA to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Adverse Events	Blood on the surface of the cuff, laryngospasm, hypoxia, hoarseness,sore throat	During the first 24 hour postoperatively
Fiberoptic Score	Fiberoptic view of PLMA placement through the airway tube was graded on a scale from 4 (best view) to 1 (worst view)	After the PLMA insertion up to 5 minutes
Airway Sealing Pressure	Fresh gas flow was adjusted to 3 L/min, and after closing the expiratory valve, the airway pressure at which an audible leak in the mouth was heard will recorded	After the PLMA insertion up to 5 minutes

Collaborators and Investigators

• Sponsor: Inonu University

Publications and helpful links

General Publications

• Koay CK, Yoong CS, Kok P. A randomized trial comparing two laryngeal mask airway insertion techniques. Anaesth Intensive Care. 2001 Dec;29(6):613-5. doi: 10.1177/0310057X0102900609.
• Sorbello M, Petrini F. Supraglottic Airway Devices: the Search for the Best Insertion Technique or the Time to Change Our Point of View? Turk J Anaesthesiol Reanim. 2017 Apr;45(2):76-82. doi: 10.5152/TJAR.2017.67764. Epub 2017 Apr 1.
• Ozgul U, Erdil FA, Erdogan MA, Begec Z, Colak C, Yucel A, Durmus M. Comparison of videolaryngoscope-guided versus standard digital insertion techniques of the ProSeal laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2019 Dec 30;19(1):244. doi: 10.1186/s12871-019-0915-3.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Airway management; General anesthesia
• Other Study ID Numbers: UlkuVL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No