Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position (LMA)

Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position

This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use.

Study Overview

• Status: Unknown
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: LMA Supreme

Detailed Description

This study is a non-randomized, observational, non-comparative prospective study to evaluate the safety, efficacy and performance of the LMA Supreme laryngeal mask airway when used according to the device's Instructions for Use. During surgery, standard treatment will be applied, complemented with the recording of study parameters related to safety, efficacy and performance of the LMA Supreme laryngeal mask airway.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Laser Spine Institute
      • Contact: Catrina Montgomery; Phone Number: 813-392-7435; Email: cmontgomery@laserspineinstitute.com
      • Contact: Sean Perry; Email: sperry@laserspineinstitute.com
      • Principal Investigator: Thor Van Diver, MD
      • Sub-Investigator: Reginald Davis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing outpatient spine surgery in the prone position that meet the eligibility criteria.

Description

Inclusion Criteria:

• 18 to 70 years of age
• American Society of Anesthesiology Classification (ASA) I-III patients
• Fasting for 8 hours
• Scheduled surgery with indication for laryngeal mask airway

Exclusion Criteria:

• Have contraindicating conditions
• Have had radiotherapy to the neck involving the hypopharynx (risk of trauma, failure to seal effectively).
• Have inadequate mouth opening to permit insertion
• History of hiatal hernia
• Scheduled for minimally invasive spine stabilization procedures such as Transforaminal Lumbar Interbody Fusion (TLIF), Anterior Cervical Discectomy and Fusion (ACDF) (all have neuromonitoring/general endotracheal intubation)
• Scheduled for Joimax procedure (initial anesthetic is MAC)
• Unable to safely position themselves prone with assistance
• History of previous failed LMA Supreme placement
• BMI greater than or equal to 53
• Outside age or ASA range specified in inclusion criteria
• Inability to comply with study requirements including follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational: LMA Supreme; An appropriately sized LMA Supreme will be prepared by removing all air from the cuff while applying manual pressure. A water soluble non-local anesthetic containing lubricant gel will be applied to the fully deflated airway before insertion. A 1 cm column of the gel will be preloaded into the gastric port of the LMA Supreme for the Gel Test. The cuff will be inflated with a manometer to a pressure of approximately 30cm H2O. If a significant leak is detected, the cuff will be inflated in increments of 5cm H2O until a satisfactory seal is obtained. The final cuff pressure will be recorded. The lungs will then be gently inflated by applying manual pressure to the anesthesia circuit bag while observing the gel column in the LMA Supreme gastric port for movement.

Device: LMA Supreme; Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1	Outcome being measured intraoperatively is the ease of manual ventilation via the LMA Supreme. Measuring, no air leaks, air leak / elevated airway pressure needed for adequate ventilation, removal and reinsertion needed to achieve adequate ventilation, no ventilation after 2 attempts (airway managed using alternative techniques	Intraoperative
The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2	Outcome being measured preoperatively and at 4 weeks +/- 5 days is the Dysphagia (difficulty swallowing) Short Questionnaire. Measuring the ability to swallow (any difficulty in swallowing), incorrect swallowing (any coughing associated with swallowing), lump feeling (any lumps in the throat), involuntary loss of weight (any weight loss recently), Pneumonia (any bouts with pneumonia).	Preoperative and up to 4 weeks (+/- 5 days) postoperative
The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1	Outcome being measured intraoperatively is any blood on the LMA upon removal. Measuring if there is minimal or no blood, blood covering less than one fourth of the LMA or blood on at least one half of the LMA surface.	Intraoperative
The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1	Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia Short Questionnaire	Instrument used to measure difficulty swallowing (dysphagia).	Preoperative and up to 4 weeks postoperative (+/- 5 days).

Collaborators and Investigators

• Sponsor: Laser Spine Institute
• Collaborators: Teleflex
• Investigators: Principal Investigator: Thor Van Diver, MD, Laser Spine Institute; Principal Investigator: George Lin, MD, Laser Spine Institute

Publications and helpful links

General Publications

• Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.
• Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
• [The Helsinki Declaration of the World Medical Association (WMA). Ethical principles of medical research involving human subjects]. Pol Merkur Lekarski. 2014 May;36(215):298-301. No abstract available. Polish.
• Verghese C, Ramaswamy B. LMA-Supreme--a new single-use LMA with gastric access: a report on its clinical efficacy. Br J Anaesth. 2008 Sep;101(3):405-10. doi: 10.1093/bja/aen174. Epub 2008 Jun 17.
• Smith I, White PF. Use of the laryngeal mask airway as an alternative to a face mask during outpatient arthroscopy. Anesthesiology. 1992 Nov;77(5):850-5. doi: 10.1097/00000542-199211000-00003.
• Brimacombe J. The advantages of the LMA over the tracheal tube or facemask: a meta-analysis. Can J Anaesth. 1995 Nov;42(11):1017-23. doi: 10.1007/BF03011075.
• Brimacombe JR, Berry A. The incidence of aspiration associated with the laryngeal mask airway: a meta-analysis of published literature. J Clin Anesth. 1995 Jun;7(4):297-305. doi: 10.1016/0952-8180(95)00026-e.
• Joshi GP, Inagaki Y, White PF, Taylor-Kennedy L, Wat LI, Gevirtz C, McCraney JM, McCulloch DA. Use of the laryngeal mask airway as an alternative to the tracheal tube during ambulatory anesthesia. Anesth Analg. 1997 Sep;85(3):573-7. doi: 10.1097/00000539-199709000-00016.
• Hohlrieder M, Brimacombe J, Eschertzhuber S, Ulmer H, Keller C. A study of airway management using the ProSeal LMA laryngeal mask airway compared with the tracheal tube on postoperative analgesia requirements following gynaecological laparoscopic surgery. Anaesthesia. 2007 Sep;62(9):913-8. doi: 10.1111/j.1365-2044.2007.05142.x.
• van Zundert A, Brimacombe J. The LMA Supreme--a pilot study. Anaesthesia. 2008 Feb;63(2):209-10. doi: 10.1111/j.1365-2044.2007.05421.x. No abstract available.
• Truhlar A, Ferson DZ. Use of the Laryngeal Mask Airway Supreme in pre-hospital difficult airway management. Resuscitation. 2008 Aug;78(2):107-8. doi: 10.1016/j.resuscitation.2008.03.008. Epub 2008 May 27. No abstract available.
• Sharma V, Verghese C, McKenna PJ. Prospective audit on the use of the LMA-Supreme for airway management of adult patients undergoing elective orthopaedic surgery in prone position. Br J Anaesth. 2010 Aug;105(2):228-32. doi: 10.1093/bja/aeq118. Epub 2010 Jun 10.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Anticipated): July 27, 2019
• Study Completion (Anticipated): July 27, 2020

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: LMA 200

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: Yes
• product manufactured in and exported from the U.S.: Yes