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

NCT03633942 | Unknown DMC FDA Device

• 1 other identifier: LMA 200
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Dysphagia Short Questionnaire

  Preoperative and up to 4 weeks postoperative (+/- 5 days).

Study Arms (1)

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

Interventions

LMA Supreme DEVICE

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

Observational: LMA Supreme

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to comply with study requirements including follow-up

Sponsors & Collaborators

• Laser Spine Institute: lead
• Teleflex: collaborator

Study Sites (1)

Laser Spine Institute

Tampa, Florida, 33607, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 1443736 BACKGROUND

• 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.

  PMID: 8590490 BACKGROUND

• 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.

  PMID: 7546756 BACKGROUND

• 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.

  PMID: 9296411 BACKGROUND

• 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.

  PMID: 9709138 BACKGROUND

• 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.

  PMID: 17697218 BACKGROUND

• 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.

  PMID: 18211462 BACKGROUND

• 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.

  PMID: 18559351 BACKGROUND

• 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.

  PMID: 18508181 BACKGROUND

• 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.

  PMID: 18211991 BACKGROUND

• 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.

  PMID: 20542887 BACKGROUND

• [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.

  PMID: 24964504 BACKGROUND

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Thor Van Diver, MD

  Laser Spine Institute

  PRINCIPAL INVESTIGATOR

• George Lin, MD

  Laser Spine Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catrina Montgomery

CONTACT

813-392-7435; cmontgomery@laserspineinstitute.com

Sean Perry

CONTACT

sperry@laserspineinstitute.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: August 16, 2018
• Study Start: July 27, 2018
• Primary Completion: July 27, 2019
• Study Completion: July 27, 2020
• Last Updated: August 24, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)