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LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984032
Enrollment
60
Registered
2019-06-12
Start date
2018-07-17
Completion date
2019-02-19
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

LMA Protector Cuff Pilot, LMA Supreme, Clinical Performance

Brief summary

Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat

Interventions

DEVICELMA Protector Cuff Pilot

Assessing the clinical performance of LMA Protector Cuff Pilot

Assessing the clinical performance of LMA Supreme

Sponsors

Liu Chian Yong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

Exclusion criteria

* BMI \> 35 * Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more) * Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)

Design outcomes

Primary

MeasureTime frameDescription
Oropharyngeal leak pressure (OLP)During induction of anaesthesiaTo assess the OLP of LMA Protector Cuff Pilot and LMA Supreme

Secondary

MeasureTime frameDescription
Mean time to insertionDuring induction of anaesthesiaTo compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme
Gastric tube insertionAfter induction of anaesthesiaTo compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme
Laryngeal viewAfter induction of anaesthesiaTo compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme
Complications24 hoursTo compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026