Airway ObstructionLMANCT03633942
Safety and Efficacy of the LMA Supreme When Inserted With Patients in the Prone Position
An observational study of Airway Obstruction, run by Laser Spine Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- LMA Supreme
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2018to 27 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing outpatient spine surgery in the prone position that meet the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sean Perry contact
United States1 site, 1 recruiting
- Recruiting
Laser Spine Institute
Tampa, Florida, 33607
Catrina Montgomery, 813-392-7435, cmontgomery@laserspineinstitute.com
Sean Perry, sperry@laserspineinstitute.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Airway Obstruction
- Being tested
- LMA Supreme
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA SupremeDevice
Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LMA Supreme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Intraoperative
Secondary outcomes (1)
Dysphagia Short Questionnaire
Instrument used to measure difficulty swallowing (dysphagia).
Measured: Preoperative and up to 4 weeks postoperative (+/- 5 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start27 Jul 2018
- Primary completion27 Jul 2019 (estimated)
- Study completion27 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laser Spine Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Responsible party
- Sponsor
- Investigators
- Thor Van Diver, MD, Principal investigator, Laser Spine InstituteGeorge Lin, MD, Principal investigator, Laser Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633942
- Sponsor's protocol ID
- LMA 200
- Acronym
- LMA
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 1443736Brimacombe 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.
PubMed 8590490Brimacombe 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.
PubMed 7546756Joshi 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.
PubMed 9296411Koga 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.
PubMed 9709138Hohlrieder 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.
PubMed 17697218van 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.
PubMed 18211462Verghese 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.
PubMed 18559351Truhlar 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.
PubMed 18508181Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
PubMed 18211991Sharma 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.
PubMed 20542887[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.
PubMed 24964504
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the LMA Supreme Supraglottic Airway Device When Used for Adult Patients Undergoing Spinal Surgery in the Prone Position
- ClinicalTrials.gov ID
- NCT03633942
- Acronym / sponsor ID
- LMA / LMA 200
- Conditions
- Airway Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Laser Spine InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Teleflex
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 27 Jul 2019 (estimated)
- Study completion
- 27 Jul 2020 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational: LMA Supreme | – | Device: LMA SupremeAn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing outpatient spine surgery in the prone position that meet the eligibility criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA SupremePlacement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position. | Device | Observational: LMA Supreme |
Primary outcome
The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1
Time frame: Intraoperative
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
The efficacy of the LMA Supreme device as assessed by measurement of ease of swallowing on Case Report Form 2
Time frame: Preoperative and up to 4 weeks (+/- 5 days) postoperative
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).
The efficacy of the LMA Supreme device as assessed by measurement of removal of the LMA Supreme Device on Case Report Form 1
Time frame: Intraoperative
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.
The efficacy of the LMA Supreme device as assessed by measurement of any intraoperative episodes developing reporting outcomes on Case Report Form 1
Time frame: Intraoperative
Outcome being measured intraoperatively is did patient develop any intraoperative episodes of laryngospasm, hiccups, or coughing.
1 secondary outcome
Dysphagia Short Questionnaire
Time frame: Preoperative and up to 4 weeks postoperative (+/- 5 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 1443736Smith 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.
- Background: PubMed 8590490Brimacombe 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.
- Background: PubMed 7546756Brimacombe 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.
- Background: PubMed 9296411Joshi 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.
- Background: PubMed 9709138Koga 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.
- Background: PubMed 17697218Hohlrieder 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.
- Background: PubMed 18211462van 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.
- Background: PubMed 18559351Verghese 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.
- Background: PubMed 18508181Truhlar 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.
- Background: PubMed 18211991Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
- Background: PubMed 20542887Sharma 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.
- Background: PubMed 24964504[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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Perry contact
Thor Van Diver, MD principal investigator
Laser Spine Institute
George Lin, MD principal investigator
Laser Spine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Obstruction, run by Laser Spine Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catrina Montgomery (813-392-7435, cmontgomery@laserspineinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of the LMA Supreme device as assessed by measurement of ventilation on Case Report Form 1 (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633942, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.