Skip to main content
OpenTrials
Completed

NCT Number: NCT02439021

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COBRA

Device

LMA

Device

Primary outcomes

  1. Oropharyngeal leak

    Time frame: Up to 1 hours

  2. 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

Secondary outcomes

  1. successful intubation attempt

    Time frame: Up to 1 hours

    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

  2. incidence of sore throat

    Time frame: Up to 1 hours

  3. incidence of dysphasia

    Time frame: Up to 1 hours

  4. incidence of postoperative blood staining on mask

    Time frame: Up to 1 hours

Sponsors and collaborators

Lead sponsor

Qazvin University Of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
First posted
May 8, 2015
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.