CClinicalTrials.gg
CompletedNCT02439021Updated May 8, 2015

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

A Phase 4 interventional study of COBRA and LMA in Obesity, sponsored by Qazvin University Of Medical Sciences. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-08.

Sponsored by Qazvin University Of Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Qazvin University Of Medical Sciences is the lead sponsor of 32 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • pregnancy
  • morbid obese (BMI>35 kg/m2)
  • a known difficult airway
  • gastro-oesophageal reflux
  • pharyngeal pathology
  • emergency operation with full stomach
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
74 participants (actual)

Study arms

  • 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

Interventions

  • DeviceCOBRA
  • DeviceLMA
06

What researchers measure

Primary outcomes

  1. Oropharyngeal leak

    Time frame: Up to 1 hours

  2. Time to intubation

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

    Time frame: Up to 1 hours

Secondary outcomes

  1. 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

    Time frame: Up to 1 hours

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02439021
Lead sponsor
Qazvin University Of Medical Sciences
Responsible party
Amir H Pakpour (Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran., Qazvin University Of Medical Sciences) — Principal investigator
First posted
May 8, 2015
Start date
Feb 2012
Primary completion
Jan 2013
Last update
May 8, 2015

Study contacts

Amir H Pakpour, PhD
principal investigator · Qazvin University Of Medical Sciences
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion