NCT02439021

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_4 obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

February 5, 2015

Last Update Submit

May 5, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • successful intubation attempt

    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

Study Arms (2)

CobraPLA

EXPERIMENTAL

Patients will randomly assign to either LMA or Cobra PLATM

Device: COBRA

LMA

EXPERIMENTAL

Patients will randomly assign to either LMA or Cobra PLATM

Device: LMA

Interventions

COBRADEVICE
CobraPLA
LMADEVICE
LMA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amir H Pakpour, PhD

    Qazvin University Of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Public Health, Qazvin University of Medical Sciences, Qazvin, Iran.

Study Record Dates

First Submitted

February 5, 2015

First Posted

May 8, 2015

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Last Updated

May 8, 2015

Record last verified: 2015-05