AirwayNCT03272776
Multicenter Study of the Protector Laryngeal Mask
An observational study of Airway, run by Matilde Zaballos at 1 site in Spain.
Trial summary
The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway
- What is being tested?
- Protector Laryngeal Mask airway
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2017to 30 Jul 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing surgery procedures in any of the collaborating centers of the study that fulfill the inclusion and exclusion criteria described below.
Who may be able to join
- Surgery procedures usually performed with supraglottic devices.
- ASA physical status I-III patients
- Age 18-75
- Signed inform consent
Who cannot join
- Patients with known difficult airway
- Patients with predicted difficult airway
- Patients with increased risk of aspiration
- Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Anestesia, Hospital General Universitario Gregorio Marañon
Madrid, 28007
About this study
Official title: A Multicenter Study of the Protector Laryngeal Mask in Non Paralyzed, Anesthetized Patients
The study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.
Read the detailed description
Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery.
LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently available for anaesthetic practice. It is made of silicone (with no latex in its composition) and shares some of the characteristics of the second generation SGDs (as the presence of a gastric access channel); however, it has an additional drainage channel, both channels terminate distally in a camera behind the mask cuff. The presence of two drainage channels ("male" and "female") increases the patient safety against regurgitation, both of distal gastric content and secretions located in the oropharyngeal region. The gastric access channel called "female" also allows the insertion of a nasogastric tube if required. These drainage channels are useful for diagnosing the correct position of the mask, since the observation of leaks or gas through it can help diagnose a displacement the mask.
LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an elliptical cross section, which ends distally in the mask. This design follows the anatomy of the human airway, which facilitates the insertion of the device. The softness of the mask material allows easy insertion.
Doubts regarding the transmission of infectious diseases with reusable devices makes disposable devices such as LMA Protector, one of the most interesting devices for use in anaesthetic procedures that are usually performed with SGD.
Its characteristics in the design, composition by a smooth and atraumatic material, the presence of two gastric drainage accesses, with potential improved patient safety and its characteristic of being disposable suggests a significant expansion of its use in the coming years .
In contrast to other SGDs that have been evaluated extensively, to date there are no large clinical studies showing its suitably and performance in a daily clinical scenario.
- Conditions
- Airway
- Being tested
- Protector Laryngeal Mask airway
- Keywords
- LMA Protector, Second Generation Laryngeal Masks, Airway, Dual Gastric Acces, Teleflex, Supraglottic Devices, Ambulatory Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protector Laryngeal Mask airwayDevice
Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.
| Study group | Role | What they receive |
|---|---|---|
| Protector Laryngeal Mask Airway | Patients undergoing anesthesia in which airway management includes a Protector Laryngeal Mask and fulfill the inclusion criteria of the study. Receives: Device: Protector Laryngeal Mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the number of attempts to insert of the LMA Protector
Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)
Measured: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol
Secondary outcomes (4)
Blood pressure during insertion of LMA protect
Blood pressure in mmHg
Measured: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
Heart rate during insertion of LMA protect
heart rate in beep per minute
Measured: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
BIS data
number from 100 (awake) to 40-45 (anesthetic status)
Measured: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA
Oropharyngeal leak pressure of the LMA Protector
The Oropharyngeal leak pressure of the LMA Protector will be determined with an intracuff pressure of 60 cm H2O by closing the expiratory valve of the breathing circle circuit at a fixed gas flow of 3 L/min and noting the pressure at which an oropharyngeal leak occurs. (in cm H2O)
Measured: The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Aug 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AirwayStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matilde Zaballos
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Sponsor-investigator, Matilde Zaballos, Hospital General Universitario Gregorio Marañon
- Investigators
- Maite López-Gil, Study chair, Servicio de Anestesiología, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272776
- Sponsor's protocol ID
- MASKAPROTECTOR
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brimacombe JR, editor. Laryngeal Mask Anesthesia. Principles and practice. 2nd Ed. Filadelfia. 2005.
Van Zundert AA, Skinner MW, Van Zundert TC, Luney SR, Pandit JJ. Value of knowing physical characteristics of the airway device before using it. Br J Anaesth. 2016 Jul;117(1):12-6. doi: 10.1093/bja/aew106. Epub 2016 May 4. No abstract available.
PubMed 27147543Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, et al. Nuevas aportaciones de la mascarilla laríngea en cirugía ambulatoria. Contribución de la mascarilla laríngea Supreme. Cir May Amb 2011; 16(2): 60-6.
Zaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, Cordero Lorenzo JM, Izquierdo Villaroya B, Lafuente Ojeda N, M. López Gil M, Rodríguez Archilla A, Zaballos Bustingorri J Recomendaciones prácticas de uso de la mascarilla laríngea en Cirugía Ambulatoria. Cir May Amb 2008; 13: (1) 4-26.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Protector Laryngeal Mask in Non Paralyzed, Anesthetized Patients
- ClinicalTrials.gov ID
- NCT03272776
- Acronym / sponsor ID
- MASKAPROTECTOR
- Conditions
- Airway
- Keywords
- LMA Protector, Second Generation Laryngeal Masks, Airway, Dual Gastric Acces, Teleflex, Supraglottic Devices, Ambulatory Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Matilde ZaballosUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 6 Sep 2017 (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 study was designed to evaluate the success rate, time of insertion, sealing efficacy and security of the Protector Laryngeal Mask, a new second generation disposable supraglottic airway device, in patients undergoing elective surgery.
Detailed description
Laryngeal masks (LM) and supraglottic devices (SGD), in all their different forms, have become an authentic innovation in airway management especially in day surgery.
LMA Protector (Teleflex Medical, Athlone, Ireland) is a new disposable SGD currently available for anaesthetic practice. It is made of silicone (with no latex in its composition) and shares some of the characteristics of the second generation SGDs (as the presence of a gastric access channel); however, it has an additional drainage channel, both channels terminate distally in a camera behind the mask cuff. The presence of two drainage channels ("male" and "female") increases the patient safety against regurgitation, both of distal gastric content and secretions located in the oropharyngeal region. The gastric access channel called "female" also allows the insertion of a nasogastric tube if required. These drainage channels are useful for diagnosing the correct position of the mask, since the observation of leaks or gas through it can help diagnose a displacement the mask.
LMA Protector is designed with a preformed anatomic curve, and the airway conduct has an elliptical cross section, which ends distally in the mask. This design follows the anatomy of the human airway, which facilitates the insertion of the device. The softness of the mask material allows easy insertion.
Doubts regarding the transmission of infectious diseases with reusable devices makes disposable devices such as LMA Protector, one of the most interesting devices for use in anaesthetic procedures that are usually performed with SGD.
Its characteristics in the design, composition by a smooth and atraumatic material, the presence of two gastric drainage accesses, with potential improved patient safety and its characteristic of being disposable suggests a significant expansion of its use in the coming years .
In contrast to other SGDs that have been evaluated extensively, to date there are no large clinical studies showing its suitably and performance in a daily clinical scenario.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protector Laryngeal Mask Airway | – | Device: Protector Laryngeal Mask airwayPatients undergoing anesthesia in which airway management includes a Protector Laryngeal Mask and fulfill the inclusion criteria of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery procedures in any of the collaborating centers of the study that fulfill the inclusion and exclusion criteria described below.
Key inclusion criteria (4 listed)
- Surgery procedures usually performed with supraglottic devices.
- ASA physical status I-III patients
- Age 18-75
- Signed inform consent
Key exclusion criteria (4 listed)
- Patients with known difficult airway
- Patients with predicted difficult airway
- Patients with increased risk of aspiration
- Patient refusal to participate in the study.
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 |
|---|---|---|
| Protector Laryngeal Mask airwayEvaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia. | Device | Protector Laryngeal Mask Airway |
Primary outcome
Evaluate the number of attempts to insert of the LMA Protector
Time frame: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol
Insertion attempts: from picking up the LMA Protector until the mask is placed into the patient mouth . (in numbers)
4 secondary outcomes
Blood pressure during insertion of LMA protect
Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
Heart rate during insertion of LMA protect
Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector
BIS data
Time frame: Baseline and every 3 minutes until 6 minutes after insertion of the LMA protector (To evaluate the evolution of BIS values during insertion of the LMA
Oropharyngeal leak pressure of the LMA Protector
Time frame: The Oropharyngeal leak pressure of the LMA Protector will be collected 5 minutes after the LMA Protector will be inserted
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 21 Feb 2019.
- BackgroundBrimacombe JR, editor. Laryngeal Mask Anesthesia. Principles and practice. 2nd Ed. Filadelfia. 2005.
- Background: PubMed 27147543Van Zundert AA, Skinner MW, Van Zundert TC, Luney SR, Pandit JJ. Value of knowing physical characteristics of the airway device before using it. Br J Anaesth. 2016 Jul;117(1):12-6. doi: 10.1093/bja/aew106. Epub 2016 May 4. No abstract available.
- BackgroundZaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, et al. Nuevas aportaciones de la mascarilla laríngea en cirugía ambulatoria. Contribución de la mascarilla laríngea Supreme. Cir May Amb 2011; 16(2): 60-6.
- BackgroundZaballos García M, López Álvarez S, Agustí Martínez-Marcos S, Blanco Sánchez T, Bustos Molina F, Cabré Fabré P, Cordero Lorenzo JM, Izquierdo Villaroya B, Lafuente Ojeda N, M. López Gil M, Rodríguez Archilla A, Zaballos Bustingorri J Recomendaciones prácticas de uso de la mascarilla laríngea en Cirugía Ambulatoria. Cir May Amb 2008; 13: (1) 4-26.
- 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.
Maite López-Gil study chair
Servicio de Anestesiología, Hospital General Universitario Gregorio Marañon
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, run by Matilde Zaballos at 1 site in Spain.
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 4 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 21 Feb 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 Spain. 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?
Evaluate the number of attempts to insert of the LMA Protector (time frame: The number of insertion attempts will be collected after anesthesia induction: 1 minute after the administration of propofol). 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 NCT03272776, which also lists 4 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 21 Feb 2019.