NCT04183959

Brief Summary

the video stylet (VS), it is considered one of the newer devices in this category. It is a portable device with liquid crystal-display module screen for visualization of vocal cords. It is considered an alternative to the flexible fiberoptic endoscope especially in the developing countries where the device cost is the main limiting factor. It has many benefits such as being light weight, easy to clean, durable, chargeable, less expensive and reusable. However newer video stylet devices have not been formally evaluated for tracheal intubation in case of laterally positioned patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

November 29, 2019

Last Update Submit

July 28, 2020

Conditions

Intubating Video Stylet

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    (defined as the time when the device is introduced into the mouth till it is removed after the confirmation of correct placement of ETT by the appearance of an optimal waveform on the capnograph

    up to 1 hour

Secondary Outcomes (3)

  • Intubation success rate

    up to 1 hour

  • Number of intubation attempts

    up to 1 hour

  • Hemodynamic stability

    up to 1 hour

Study Arms (2)

Group- video stylet intubation (VS)

ACTIVE COMPARATOR

trachea will be intubated using laryngoscopic assisted video stylet device in lateral position

Device: video stylet

Group- fiberoptic intubation (FO)

ACTIVE COMPARATOR

: intubation will be done using fiberoptic device by the same anesthesiologist in lateral position

Device: fiberoptic

Interventions

video styletDEVICE

trachea will be intubated using laryngoscopic assisted video stylet device in lateral position

Group- video stylet intubation (VS)
fiberopticDEVICE

intubation will be done using fiberoptic device by the same anesthesiologist in lateral position

Group- fiberoptic intubation (FO)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient age 18- 60 years.
  • Both sexes
  • American Society of Anesthesiologists(ASA) physical status classes I and II.
  • Non-obese patients ( BMI \<35)

You may not qualify if:

  • Difficult intubation; mallampati 3 or 4, Dental abnormalities, Cervical spine pathology that limits neck mobility , obese patients ( BMI ≥ 35) .
  • Cardiovascular disease, hypertensive patients, Pregnant and nursing women, High risk of pulmonary aspiration.
  • Patients at risk of bleeding either impaired bleeding profile or receiving anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Optical Fibers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and Supplies

Study Officials

  • Nesrine Elrefai, MD

    Professor of Anaesthesia, surgical ICU &Pain management

    PRINCIPAL INVESTIGATOR

  • Sohaila Omar, MD

    Professor of Anaesthesia and surgical ICU

    PRINCIPAL INVESTIGATOR

  • Mohamed Hussien, MD

    Lecturer of Anaesthesia and surgical ICU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

December 3, 2019

Primary Completion

June 16, 2020

Study Completion

July 22, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

EG(1)