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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: COBRA; Device: LMA

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CobraPLA; Patients will randomly assign to either LMA or Cobra PLATM	Device: COBRA
Experimental: LMA; Patients will randomly assign to either LMA or Cobra PLATM	Device: LMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal leak		Up to 1 hours
Time to intubation	Time to intubation was measured from inserting of the device to the patient's month while connecting the breathing circuit	Up to 1 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful intubation attempt	A 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	Up to 1 hours
incidence of sore throat		Up to 1 hours
incidence of dysphasia		Up to 1 hours
incidence of postoperative blood staining on mask		Up to 1 hours

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences
• Investigators: Principal Investigator: Amir H Pakpour, PhD, Qazvin University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 5, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimate): May 8, 2015

Study Record Updates

• Last Update Posted (Estimate): May 8, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 653