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Effectiveness of the New Perilaryngeal Airway in Comparison With the Laryngeal Mask Airway

Effectiveness of the New Perilaryngeal Airway (CobraPLA™) in Comparison With the Laryngeal Mask Airway (LMA™) to Improve Oropharyngeal Leak Pressure Among Obese and Overweight Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02439021
Enrollment
74
Registered
2015-05-08
Start date
2012-02-29
Completion date
Unknown
Last updated
2015-05-08

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

Conditions

Obesity

Brief summary

The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.

Interventions

DEVICECOBRA
DEVICELMA

Sponsors

Qazvin University Of Medical Sciences
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

* BMI between 25 to 35 kg/m2 * scheduled for surgery * being older than 18 years * Mallampati class I-III and BMI between 25 and 35

Exclusion criteria

* pregnancy * morbid obese (BMI\>35 kg/m2) * a known difficult airway * gastro-oesophageal reflux * pharyngeal pathology * emergency operation with full stomach

Design outcomes

Primary

MeasureTime frameDescription
Oropharyngeal leakUp to 1 hours
Time to intubationUp to 1 hoursTime to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit

Secondary

MeasureTime frameDescription
successful intubation attemptUp to 1 hoursA successful intubation attempt was recognized if: the breathing circuit connected, the EtCO2 trace was revealed, and no air leak was detected at airway pressures of 15 cm H2O
incidence of sore throatUp to 1 hours
incidence of dysphasiaUp to 1 hours
incidence of postoperative blood staining on maskUp to 1 hours

Outcome results

None listed

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