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Clinical Trials/NCT02439021
NCT02439021
Completed
Phase 4

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

Qazvin University Of Medical Sciences0 sites74 target enrollmentFebruary 2012
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ConditionsObesity

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Obesity
Sponsor
Qazvin University Of Medical Sciences
Enrollment
74
Primary Endpoint
Time to intubation
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
January 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amir H Pakpour

Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran.

Qazvin University Of Medical Sciences

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to intubation

Time Frame: Up to 1 hours

Time to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit

Oropharyngeal leak

Time Frame: Up to 1 hours

Secondary Outcomes

  • incidence of postoperative blood staining on mask(Up to 1 hours)
  • successful intubation attempt(Up to 1 hours)
  • incidence of sore throat(Up to 1 hours)
  • incidence of dysphasia(Up to 1 hours)

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