NCT02884869

Brief Summary

Control the airways by endotracheal intubation is an important part of treatment for a trauma casualty. The use of the Laryngeal Mask Airway for fast control of the airway is known for many years. The aim of this study is to examine the effectiveness of the Intubating Laryngeal Mask Airway to achieve a definitive airway by unskilled practitioners. The hypothesis is that definitive airway obtaining with Intubating Laryngeal Mask Airway will be more success and faster compared to the standard way of direct laryngoscope.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Status
unknown

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

August 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

Same day

First QC Date

August 16, 2016

Last Update Submit

August 30, 2016

Conditions

Adverse Anesthesia Outcome

Keywords

Blind intubation,Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (1)

  • Time of blind intubation measure in second

    Time of blind intubation in seconds

    30 seconds

Secondary Outcomes (1)

  • Easy to perform intubation measure in numeric scale

    30 seconds

Study Arms (2)

Intubating laryngeal Mask

EXPERIMENTAL

Intubating laryngeal Mask

Device: Intubating Laryngeal Mask

Direct laryngoscopy

ACTIVE COMPARATOR

Intubating laryngeal Mask

Device: Intubating Laryngeal Mask

Interventions

Intubating Laryngeal MaskDEVICE

Direct laryngoscopy

Direct laryngoscopyIntubating laryngeal Mask

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society Anesthesiology class I and II

You may not qualify if:

  • Difficult airway
  • Cervical pathology
  • Full stomach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Luis A Gaitini, M.D.

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis A Gaitini, M.D.

CONTACT

# 972 4 8359346luis.gaitini@b-zion.org.il

Mostafa Somri, M.D.

CONTACT

# 972 4 8359346mostafa.somri@b-zion.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 31, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2017

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share