Airway Complication of AnesthesiaNCT03462550
A Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery Unit
A study testing Laryngeal mask in people with Airway Complication of Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA Protector is manufactured. Read more about this study
- Who is it for?
- Ages 19 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Laryngeal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jul 2017to 21 Mar 2018
- Phase
- Interventional
- 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 19 to 71 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are planned for elective minor surgery in the ambulatory surgery unit, who are ASA I or II or III, aged 19-71 years, whose operation is routinely done with a Laryngeal Mask Airway in the supine position.
Who cannot join
- Patients are excluded if they are <19 or >71 years, have an anticipated difficult airway, a body mass index > 35kg.m-2 or are at risk of aspiration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery Unit
The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA Protector is manufactured.
The primary hypothesis of this study is: the oropharyngeal leak pressure of the LMA Protector is 5 cmH2O higher than the oropharyngeal leak pressure of the LMA Supreme. Secondary outcome measures are: ease of insertion, fibreoptic position, ease of gastric tube placement.
Differences between LMA Supreme and LMA Protector are: the LMA protector has a dual gastric drainage channel, LMA supreme one. For LMA protector, airway tube and cuff are 100% silicone, in LMA supreme the cuff is polivinylchloride. Silicone cuffs have shown to reduce risk of sore throat and achieve higher seal pressures. There are no aperture bars in the LMA protector (2 in LMA supreme). The tube of LMA protector is more flexible. An integrated cuff pressure indicator for single use airway management devices that enables continuous cuff pressure monitoring only in the LMA protector.
Read the detailed description
- Outpatients planned for elective minor surgery, routinely done with LMA, will be asked to participate in the study.
- The patient is preoxygenated for 3 min. Anaesthesia is induced with 0.15 mcg/kg sufentanil and 1 - 4 mg/kg propofol. Routine monitoring is used together with BIS-monitoring. No neuromuscular relaxing agent is used. Patients lungs will be ventilated with a face mask for 3 min and then the LMA will be inserted while the neck of the patient is flexed, the head extended. LMA cuff is completely deflated. The LMA is inserted using a single-handed rotational technique. Failed insertion is defined as: failed passage in the pharynx, malposition (air leak) and ineffective ventilation (expired tidal volume<25% of administered volume). The time between picking up the LMA and successful placement is recorded. When failed on the first attempt the LMA will be inserted with a digital guided technique. A Third attempt will be a gum-elastic-bougie guided technique.
- Oropharyngeal leak pressure is determined at 0-40ml cuff volume in 10 ml increments. The expiratory valve of the circle system is closed at a fixed gas flow of 3 l/min and noting the airway pressure at equilibrium (max allowed 40 cmH2O)
- Fiber optic position: 4=only vocal cords visible, 3=vocal cords + posterior epiglottis, 2=vocal cords + anterior epiglottis, 1=vocal cords not seen. Fiber optic position will only be evaluated if available at the moment of the study.
- Cuff pressure is set at 65 cmH2O using a manometer and patients lungs are ventilated at a tidal volume of 10 ml/kg, at a respiratory rate of 12/min. Presence of air leak is detected by listening over the mouth, gastric air leak (stethoscope over epigastrium, larynx, drain tube air leaks (lubricant over proximal end) or end-tidal CO2 > 45 mmHg. Respiratory settings are changed at the discretion of the anesthesiologist after successful placement.
- Correct gastric tube placement is assessed by suction of fluid. Cardiorespiratory data are collected: bradycardia >100/min, tachycardia >, hypotension, hypoxaemia
- Upon removal of the LMA at the end of the procedure the device will be checked for blood staining.
- At discharge from day surgery unit patients will be asked for presence of sore throat.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal maskDevice
LMA insertion
| Study group | Role | What they receive |
|---|---|---|
| LMA Supreme | Active comparator | Not described Receives: Device: Laryngeal mask |
| LMA Protector | Experimental | Not described Receives: Device: Laryngeal mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Leak Pressure
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start26 Jul 2017
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462550
- Sponsor's protocol ID
- EC/2017/0117
- Status last verified
- Jan 2023
- First submitted
- 6 Mar 2018
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acx E, Van Caelenberg E, De Baerdemaeker L, Coppens M. Laryngeal mask airway protector generates higher oropharyngeal leak pressures compared to the laryngeal mask airway supreme: A randomized clinical trial in the ambulatory surgery unit. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):221-225. doi: 10.4103/joacp.JOACP_416_19. Epub 2021 Jul 15.
PubMed 34349370
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Laryngeal Mask Airway Supreme With the Laryngeal Mask Airway Protector In the Ambulatory Surgery Unit
- ClinicalTrials.gov ID
- NCT03462550
- Acronym / sponsor ID
- EC/2017/0117
- Conditions
- Airway Complication of Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 12 Mar 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.
The Laryngeal Mask Airway is a supraglottic airway device that has been used in anesthesia for decades. Now the third generation (LMA Supreme) is commonly used. Recently the LMA Protector is manufactured.
The primary hypothesis of this study is: the oropharyngeal leak pressure of the LMA Protector is 5 cmH2O higher than the oropharyngeal leak pressure of the LMA Supreme. Secondary outcome measures are: ease of insertion, fibreoptic position, ease of gastric tube placement.
Differences between LMA Supreme and LMA Protector are: the LMA protector has a dual gastric drainage channel, LMA supreme one. For LMA protector, airway tube and cuff are 100% silicone, in LMA supreme the cuff is polivinylchloride. Silicone cuffs have shown to reduce risk of sore throat and achieve higher seal pressures. There are no aperture bars in the LMA protector (2 in LMA supreme). The tube of LMA protector is more flexible. An integrated cuff pressure indicator for single use airway management devices that enables continuous cuff pressure monitoring only in the LMA protector.
Detailed description
- Outpatients planned for elective minor surgery, routinely done with LMA, will be asked to participate in the study.
- The patient is preoxygenated for 3 min. Anaesthesia is induced with 0.15 mcg/kg sufentanil and 1 - 4 mg/kg propofol. Routine monitoring is used together with BIS-monitoring. No neuromuscular relaxing agent is used. Patients lungs will be ventilated with a face mask for 3 min and then the LMA will be inserted while the neck of the patient is flexed, the head extended. LMA cuff is completely deflated. The LMA is inserted using a single-handed rotational technique. Failed insertion is defined as: failed passage in the pharynx, malposition (air leak) and ineffective ventilation (expired tidal volume<25% of administered volume). The time between picking up the LMA and successful placement is recorded. When failed on the first attempt the LMA will be inserted with a digital guided technique. A Third attempt will be a gum-elastic-bougie guided technique.
- Oropharyngeal leak pressure is determined at 0-40ml cuff volume in 10 ml increments. The expiratory valve of the circle system is closed at a fixed gas flow of 3 l/min and noting the airway pressure at equilibrium (max allowed 40 cmH2O)
- Fiber optic position: 4=only vocal cords visible, 3=vocal cords + posterior epiglottis, 2=vocal cords + anterior epiglottis, 1=vocal cords not seen. Fiber optic position will only be evaluated if available at the moment of the study.
- Cuff pressure is set at 65 cmH2O using a manometer and patients lungs are ventilated at a tidal volume of 10 ml/kg, at a respiratory rate of 12/min. Presence of air leak is detected by listening over the mouth, gastric air leak (stethoscope over epigastrium, larynx, drain tube air leaks (lubricant over proximal end) or end-tidal CO2 > 45 mmHg. Respiratory settings are changed at the discretion of the anesthesiologist after successful placement.
- Correct gastric tube placement is assessed by suction of fluid. Cardiorespiratory data are collected: bradycardia >100/min, tachycardia >, hypotension, hypoxaemia
- Upon removal of the LMA at the end of the procedure the device will be checked for blood staining.
- At discharge from day surgery unit patients will be asked for presence of sore throat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA Supreme | Active comparator | Device: Laryngeal mask |
| LMA Protector | Experimental | Device: Laryngeal mask |
Who may qualify
- Ages
- 19 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are planned for elective minor surgery in the ambulatory surgery unit, who are ASA I or II or III, aged 19-71 years, whose operation is routinely done with a Laryngeal Mask Airway in the supine position.
Key exclusion criteria (1 listed)
- Patients are excluded if they are <19 or >71 years, have an anticipated difficult airway, a body mass index > 35kg.m-2 or are at risk of aspiration.
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 |
|---|---|---|
| Laryngeal maskLMA insertion | Device | LMA Protector, LMA Supreme |
Primary outcome
Airway Leak Pressure
Time frame: perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 34349370Acx E, Van Caelenberg E, De Baerdemaeker L, Coppens M. Laryngeal mask airway protector generates higher oropharyngeal leak pressures compared to the laryngeal mask airway supreme: A randomized clinical trial in the ambulatory surgery unit. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):221-225. doi: 10.4103/joacp.JOACP_416_19. Epub 2021 Jul 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal mask in people with Airway Complication of Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jan 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Leak Pressure (time frame: perioperative). 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 NCT03462550, which also lists 1 linked publication.
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 4 Jan 2023.