NCT04453683

Brief Summary

To compare air Q versus ILMA intubation in obese adult paralyzed patient

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

June 28, 2020

Last Update Submit

January 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • success rate of tracheal intubation through each device.

    success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time

    Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices

Secondary Outcomes (1)

  • Insertion time of supraglottic airway devices

    It is about 13-19 second for insertion of supraglottic airway devices

Study Arms (2)

Group I ( Air Q)

ACTIVE COMPARATOR

nsertion of proper size Air-Q. ILA

Device: Air-Q. ILA insertion of proper size

Group II (ILMA)

ACTIVE COMPARATOR

nsertion of proper size ILMA

Device: ILMA insertion of proper size

Interventions

Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device

Group I ( Air Q)

Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device

Group II (ILMA)

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status (I-II)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, 002055, Egypt

Location

Related Publications (2)

  • Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.

    PMID: 12707159BACKGROUND
  • Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.

    PMID: 21320087BACKGROUND

Study Officials

  • Heba M EL-Asser, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR
  • Khadiga M El Hossiney, MD

    Zagazig University

    STUDY CHAIR
  • Amani A Aly

    Zagazig University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 28, 2020

First Posted

July 1, 2020

Study Start

June 20, 2019

Primary Completion

June 20, 2020

Study Completion

June 20, 2020

Last Updated

January 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations