Clinical trial NCT03633942: Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position
Official title: Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Airway Obstruction
Lead sponsor: Laser Spine Institute
Sponsor class: INDUSTRY
Collaborators: name: Teleflex
First posted: 2018-08-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing outpatient spine surgery in the prone position that meet the eligibility criteria.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1
timeFrame: Intraoperative
measure: The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2
timeFrame: Preoperative and up to 4 weeks (+/- 5 days) postoperative
measure: The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1
timeFrame: Intraoperative
measure: The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1
timeFrame: Intraoperative
Secondary outcomes:
measure: Dysphagia Short Questionnaire
timeFrame: Preoperative and up to 4 weeks postoperative (+/- 5 days).
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Laser Spine Institute
state: Florida
Study officials:
affiliation: Laser Spine Institute
name: Thor Van Diver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laser Spine Institute
name: George Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: [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.