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

Airway Obstruction Clinical Trial

— LMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633942
• Other study ID #: LMA 200
• Status: Recruiting
• Start date: July 27, 2018
• Est. completion date: July 27, 2020

Study information

• Verified date: August 2018
• Source: Laser Spine Institute
• Contact: Catrina Montgomery
• Phone: 813-392-7435
• Email: cmontgomery[@]laserspineinstitute.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: July 27, 2020
• Est. primary completion date: July 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

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

Locations

Country	Name	City	State
United States	Laser Spine Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Laser Spine Institute	Teleflex

Country where clinical trial is conducted

United States, 

References & Publications (12)

[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. Polish. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Dysphagia Short Questionnaire	Instrument used to measure difficulty swallowing (dysphagia).	Preoperative and up to 4 weeks postoperative (+/- 5 days).