Efficacy of Oropharyngeal Seal PressureGuardianNCT02063516

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

A study testing Guardian Laryngeal Mask and Proseal Laryngeal Mask Airway in people with Efficacy of Oropharyngeal Seal Pressure, run by Tianjin Medical University General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Efficacy of Oropharyngeal Seal Pressure
What is being tested?: Guardian Laryngeal Mask and Proseal Laryngeal Mask Airway
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: Jun 2013to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

None listed.

Who cannot join

Body weight 50 Kg
Pregnancy
Difficult airway
Recent history of upper respiratory tract infection and sore throats
A history of esophageal reflux disease
ENT surgery
Laparoscopic surgery
Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Read the detailed description

Condition:

The study focuses on the comparison of the ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement between the Guardian LMA and the LMA Proseal in paralyzed, anesthetized patients.

Device: Guardian Laryngeal Mask Device: LMA Proseal

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Conditions: Efficacy of Oropharyngeal Seal Pressure
Being tested: Guardian Laryngeal Mask, Proseal Laryngeal Mask Airway
Keywords: Airway Cuff, Guardian, Proseal, Cuff Pressure, laryngeal Mask Airway

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guardian Laryngeal MaskDevice
Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.
Proseal Laryngeal Mask AirwayDevice
Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube

Study groups in NCT02063516
Study group	Role	What they receive
Guardian	Experimental	Device: Guardian Laryngeal Mask Receives: Device: Guardian Laryngeal Mask
Proseal	Experimental	Device:Proseal Laryngeal Mask Airway Receives: Device: Proseal Laryngeal Mask Airway

What is being measured

The primary outcome is the main question the study is designed to answer.

Oropharyngeal Seal Pressure
This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.
Measured: 5 min

Secondary outcomes (1)

Anatomic Position
This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.
Measured: 5 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Nov 2014

First posted14 Feb 2014 (estimated)
Study startJun 2013
Primary completionAug 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Efficacy of Oropharyngeal Seal PressureStudies 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: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063516
Sponsor's protocol ID: Wang001
Acronym: Guardian
Status last verified: Dec 2014
First submitted: 13 Jan 2014
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.
PubMed 25929558

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal - A Perspective, Randomized，Blind Study
ClinicalTrials.gov ID: NCT02063516
Acronym / sponsor ID: Guardian / Wang001
Conditions: Efficacy of Oropharyngeal Seal Pressure
Keywords: Airway Cuff, Guardian, Proseal, Cuff Pressure, laryngeal Mask Airway
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Tianjin Medical University General HospitalUniversity, hospital or other
Study start: Jun 2013
Primary completion: Aug 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 18 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Detailed description

Condition:

Device: Guardian Laryngeal Mask Device: LMA Proseal

Study Type:

Interventional

Study Design:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Guardian	Experimental	Device: Guardian Laryngeal MaskDevice: Guardian Laryngeal Mask
Proseal	Experimental	Device: Proseal Laryngeal Mask AirwayDevice:Proseal Laryngeal Mask Airway

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (8 listed)

Body weight 50 Kg
Pregnancy
Difficult airway
Recent history of upper respiratory tract infection and sore throats
A history of esophageal reflux disease

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
Guardian Laryngeal MaskGuardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.	Device	Guardian
Proseal Laryngeal Mask AirwayProseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube	Device	Proseal

Primary outcome

Oropharyngeal Seal Pressure
Time frame: 5 min
This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.

1 secondary outcome

Anatomic Position
Time frame: 5 min

Results and safety

Results posted to the registry on 18 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guardian	40	40
Proseal	40	40

Primary outcome: Oropharyngeal Seal Pressure

Time frame: 5 min. Mean (Standard Deviation). Unit: cmH2O

Measure	Guardian n = 40	Proseal n = 40
Value	32.36 (4.93)	29.41 (4.33)

Guardian vs Proseal: p = 0.04, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1, 2 and 24 hours after the end of surgery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guardian	0 of 40 (0%)	10 of 40 (25%)	Not reported
Proseal	0 of 40 (0%)	12 of 40 (30%)	Not reported

Limitations and caveats (from the sponsor): We only use size-4 devices in adult patients with neuromuscular blockade, we presumed that same results would be obtained in patients who have not received neuromuscular blockade. lastly our data was not blinded causing potential source of bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25929558Pajiyar AK, Wen Z, Wang H, Ma L, Miao L, Wang G. Comparisons of clinical performance of Guardian laryngeal mask with laryngeal mask airway ProSeal. BMC Anesthesiol. 2015 May 1;15:69. doi: 10.1186/s12871-015-0039-3.

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?

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 0 inclusion and 8 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 26 Jan 2015. 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 China. 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?

Yes. Results are posted in the registry (first posted 18 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Oropharyngeal Seal Pressure (time frame: 5 min). 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 NCT02063516, 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 26 Jan 2015.