NCT02095470

Brief Summary

new glidoscope was tested on 401 patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
401

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

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

February 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
Last Updated

March 24, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

March 15, 2014

Last Update Submit

March 20, 2014

Conditions

Elective Intubation

Keywords

LaryngoscopyEquipmentVideo Laryngoscope

Outcome Measures

Primary Outcomes (3)

  • laryngoscopy grade

    grade of laryngoscopy

    hospital stay (average 48 hours)

  • time to intubation

    time to successful intubation in minutes

    60 minutes

  • unsuccessful attempts

    number of failure

    60 minutes

Secondary Outcomes (1)

  • aspiration

    hospital stay ( 48 hours)

Study Arms (2)

videolaryngoscope group

EXPERIMENTAL

video laryngoscopy was done for them

Device: video laryngoscope

traditional laryngoscope

PLACEBO COMPARATOR

comparison to active group with routine laryngoscope

Device: traditional laryngoscope

Interventions

video laryngoscopeDEVICE

newly developed innovatory device

Also known as: glidescope
videolaryngoscope group
traditional laryngoscopeDEVICE

traditional way for intubation

traditional laryngoscope

Eligibility Criteria

Age19 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective operation who filled the consent

You may not qualify if:

  • poor intubation
  • emergency cases
  • hemodynamic derangement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz Universty of Mesical Sciences

Shiraz, Fars, Iran

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 15, 2014

First Posted

March 24, 2014

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

February 1, 2014

Last Updated

March 24, 2014

Record last verified: 2014-03

Locations

IR(1)