Laryngeal MasksNCT03852589
The Effect of Placement of Proseal Laryngeal Mask Airway With C-Mac Videolaryngoscopy
A study testing C-MAC videolaryngoscope and Blind in people with Laryngeal Masks and Anesthesia, General, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laryngeal Masks, Anesthesia, General, Videolaryngoscopy
- What is being tested?
- C-MAC videolaryngoscope and Blind
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 65 years
- Undergoing short surgical prcedures with general anesthesia using a PLMA
- American Society of Anesthesiology score I-II
Who cannot join
- Anticipated difficult airway
- Risk of aspiration
- Patients who refused written informed consent forms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of C-MAC Videolaryngoscopy-guided Proseal Laryngeal Mask Airway Placement vs Conventional Blind Technique: a Prospective Randomized Study
The ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. The manufacturer recommends inserting the ProSealTM LMA using digital manipulation or with an introducer tool, but both these techniques have lower success rates than the classic LMA.
This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.
Read the detailed description
Airway management is one of the cornerstones for modern anaesthesia and is vital for all patients undergoing general anaesthesia. Supraglottic airway devices (SADs) are increasingly used for managing airways.
The ProSeal laryngeal mask airway (PLMA) (Laryngeal Mask Company, San Diego, CA, USA) is a supraglottic airway device with a larger cuff than the Classic laryngeal mask airway to produce a better seal. The PLMA is also equipped with a drainage tube to permit insertion of a gastric tube and evacuation of gastric content. The presence of the drainage tube reduces the risk of aspiration, which is the major concern of the Classic laryngeal mask airway, especially when the device is used with positive pressure ventilation. While a dedicated introducer (commonly known as an ''introducer tool'') is recommended by the manufacturer to facilitate insertion of the PLMA, difficulties can still be encountered during insertion. The PLMA insertion success rate at first attempt has been reported as 82-87%, which is lower than the insertion success rate of the Classic laryngeal mask airway.
Malpositioning of the PLMA is common in clinical practice because its soft cuff can fold over onto itself. Malpositioning of the device can result in severe leaks and even obstruction of the airway, with potentially negative outcomes for the patient. Although the incidence of complications(e.g. airway trauma, obstruction, regurgitation, gastric distension with mechanical ventilation) is likely to be higher with an incorrectly placed SAD, clinical airway obstruction can result from other causes, such as laryngospasm and transient closure of the glottis.
Many methods have been proposed to facilitate insertion of PLMAs, including insertion of a gastric tube,a suction catheter, or a gum elastic bougie into the drainage tube. These techniques help to prevent the PLMA soft cuff from folding over and help to decrease the incidence of malpositioning.
This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.
- Conditions
- Laryngeal Masks, Anesthesia, General, Videolaryngoscopy
- Being tested
- C-MAC videolaryngoscope, Blind
- Keywords
- Airway management, Videolaryngoscopy, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-MAC videolaryngoscopeDevice
An intubating device that is used for endotracheal intubation. PLMA will inserted by anesthesiologist with C-MAC videolaryngoscope.
BlindDevice
PLMA will inserted by anesthesiologist with digital finger.
| Study group | Role | What they receive |
|---|---|---|
| C-MAC Videolaryngoscope | Active comparator | C-MAC Videolaryngoscope: An intubating device that is used for endotracheal intubation. Proseal laryngeal mask airway will be inserted with C-MAC Videolaryngoscope Receives: Device: C-MAC videolaryngoscope |
| Blind | Active comparator | Proseal laryngeal mask airway will be inserted with digital finger Receives: Device: Blind |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
The PLMA will inserted into hypopharynx, the cuff will inflated with an appropraite volume of air. An effective airway will judged by a square wave on capnography.
Measured: From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes
Secondary outcomes (4)
Insertion time
Insertion time was the time between picking up the PLMA and successful placement
Measured: From inserted PLMA to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Adverse Events
Blood on the surface of the cuff, laryngospasm, hypoxia, hoarseness,sore throat
Measured: During the first 24 hour postoperatively
Fiberoptic Score
Fiberoptic view of PLMA placement through the airway tube was graded on a scale from 4 (best view) to 1 (worst view)
Measured: After the PLMA insertion up to 5 minutes
Airway Sealing Pressure
Fresh gas flow was adjusted to 3 L/min, and after closing the expiratory valve, the airway pressure at which an audible leak in the mouth was heard will recorded
Measured: After the PLMA insertion up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ülkü Özgül, Inonu University
- Investigators
- Ulku Ozgul, Principal investigator, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852589
- Sponsor's protocol ID
- UlkuVL
- Status last verified
- Apr 2019
- First submitted
- 22 Feb 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koay CK, Yoong CS, Kok P. A randomized trial comparing two laryngeal mask airway insertion techniques. Anaesth Intensive Care. 2001 Dec;29(6):613-5. doi: 10.1177/0310057X0102900609.
PubMed 11771605Sorbello M, Petrini F. Supraglottic Airway Devices: the Search for the Best Insertion Technique or the Time to Change Our Point of View? Turk J Anaesthesiol Reanim. 2017 Apr;45(2):76-82. doi: 10.5152/TJAR.2017.67764. Epub 2017 Apr 1.
PubMed 28439437Ozgul U, Erdil FA, Erdogan MA, Begec Z, Colak C, Yucel A, Durmus M. Comparison of videolaryngoscope-guided versus standard digital insertion techniques of the ProSeal laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2019 Dec 30;19(1):244. doi: 10.1186/s12871-019-0915-3.
PubMed 31888511
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of C-MAC Videolaryngoscopy-guided Proseal Laryngeal Mask Airway Placement vs Conventional Blind Technique: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03852589
- Acronym / sponsor ID
- UlkuVL
- Conditions
- Laryngeal Masks, Anesthesia, General, Videolaryngoscopy
- Keywords
- Airway management, Videolaryngoscopy, General anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 25 Feb 2019 (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 ProSeal laryngeal mask airway (ProSeal LMA; Intavent Orthofix, Maidenhead, UK) is a device with a double cuff to improve the seal and a drain tube to help prevent aspiration and gastric insufflation, facilitate passage of a gastric tube, and provide information about malposition. The manufacturer recommends inserting the ProSealTM LMA using digital manipulation or with an introducer tool, but both these techniques have lower success rates than the classic LMA.
This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.
Detailed description
Airway management is one of the cornerstones for modern anaesthesia and is vital for all patients undergoing general anaesthesia. Supraglottic airway devices (SADs) are increasingly used for managing airways.
The ProSeal laryngeal mask airway (PLMA) (Laryngeal Mask Company, San Diego, CA, USA) is a supraglottic airway device with a larger cuff than the Classic laryngeal mask airway to produce a better seal. The PLMA is also equipped with a drainage tube to permit insertion of a gastric tube and evacuation of gastric content. The presence of the drainage tube reduces the risk of aspiration, which is the major concern of the Classic laryngeal mask airway, especially when the device is used with positive pressure ventilation. While a dedicated introducer (commonly known as an ''introducer tool'') is recommended by the manufacturer to facilitate insertion of the PLMA, difficulties can still be encountered during insertion. The PLMA insertion success rate at first attempt has been reported as 82-87%, which is lower than the insertion success rate of the Classic laryngeal mask airway.
Malpositioning of the PLMA is common in clinical practice because its soft cuff can fold over onto itself. Malpositioning of the device can result in severe leaks and even obstruction of the airway, with potentially negative outcomes for the patient. Although the incidence of complications(e.g. airway trauma, obstruction, regurgitation, gastric distension with mechanical ventilation) is likely to be higher with an incorrectly placed SAD, clinical airway obstruction can result from other causes, such as laryngospasm and transient closure of the glottis.
Many methods have been proposed to facilitate insertion of PLMAs, including insertion of a gastric tube,a suction catheter, or a gum elastic bougie into the drainage tube. These techniques help to prevent the PLMA soft cuff from folding over and help to decrease the incidence of malpositioning.
This prospective study that will investigated the usefulness of the C-MAC videolaryngoscopy for inserting a PLMA in anesthetized non-paralyzed patients and compared it with the index finger.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-MAC Videolaryngoscope | Active comparator | Device: C-MAC videolaryngoscopeC-MAC Videolaryngoscope: An intubating device that is used for endotracheal intubation. Proseal laryngeal mask airway will be inserted with C-MAC Videolaryngoscope |
| Blind | Active comparator | Device: BlindProseal laryngeal mask airway will be inserted with digital finger |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18- 65 years
- Undergoing short surgical prcedures with general anesthesia using a PLMA
- American Society of Anesthesiology score I-II
Key exclusion criteria (3 listed)
- Anticipated difficult airway
- Risk of aspiration
- Patients who refused written informed consent forms
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 |
|---|---|---|
| C-MAC videolaryngoscopeAn intubating device that is used for endotracheal intubation. PLMA will inserted by anesthesiologist with C-MAC videolaryngoscope. | Device | C-MAC Videolaryngoscope |
| BlindPLMA will inserted by anesthesiologist with digital finger. | Device | Blind |
Primary outcome
First attempt success rate
Time frame: From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes
The PLMA will inserted into hypopharynx, the cuff will inflated with an appropraite volume of air. An effective airway will judged by a square wave on capnography.
4 secondary outcomes
Insertion time
Time frame: From inserted PLMA to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes
Adverse Events
Time frame: During the first 24 hour postoperatively
Fiberoptic Score
Time frame: After the PLMA insertion up to 5 minutes
Airway Sealing Pressure
Time frame: After the PLMA insertion up to 5 minutes
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 9 Apr 2019.
- Background: PubMed 11771605Koay CK, Yoong CS, Kok P. A randomized trial comparing two laryngeal mask airway insertion techniques. Anaesth Intensive Care. 2001 Dec;29(6):613-5. doi: 10.1177/0310057X0102900609.
- Background: PubMed 28439437Sorbello M, Petrini F. Supraglottic Airway Devices: the Search for the Best Insertion Technique or the Time to Change Our Point of View? Turk J Anaesthesiol Reanim. 2017 Apr;45(2):76-82. doi: 10.5152/TJAR.2017.67764. Epub 2017 Apr 1.
- Derived from this study: PubMed 31888511Ozgul U, Erdil FA, Erdogan MA, Begec Z, Colak C, Yucel A, Durmus M. Comparison of videolaryngoscope-guided versus standard digital insertion techniques of the ProSeal laryngeal mask airway: a prospective randomized study. BMC Anesthesiol. 2019 Dec 30;19(1):244. doi: 10.1186/s12871-019-0915-3.
- Individual participant dataSharing planned: No
Related trials for Laryngeal Masks
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
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.
Ulku Ozgul principal investigator
Inonu University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-MAC videolaryngoscope and Blind in people with Laryngeal Masks and Anesthesia, General, run by Inonu University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 9 Apr 2019. 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 Turkey (Türkiye). 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?
First attempt success rate (time frame: From inserted PLMA to seeing meaningful end-tidal carbon dioxide levels up to 2 minutes). 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 NCT03852589, which also lists 3 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 9 Apr 2019.