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Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Intubating Video Stylet

Treatments

Device: fiberoptic
Device: video stylet

Study type

Interventional

Funder types

Other

Identifiers

NCT04183959
MD-53-2019

Details and patient eligibility

About

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.

Full description

Following approval from Ethics and Research Committee of Theodor Bilharz Research Institute, the study protocol will be explained to the patients after taking their consent.

Upon arrival to the operating room, a 20 G cannula will be sited intravenously and infusion of Ringer's solution will be started. Intravenous midazolam in a dose of 0.05 mg/ Kg will be given. Then, a five-lead electrocardiogram (GE-Datex Ohmeda 5 lead ECG cable), a pulse oximeter (GE- Datex Ohmeda adult finger spO2 sensor) and a non-invasive blood pressure monitor (GE-Datex Ohmeda NIBP cuff, adult double tube with bag) will be attached to the patient.

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Group- video stylet intubation (VS)
Active Comparator group
Description:
trachea will be intubated using laryngoscopic assisted video stylet device in lateral position
Treatment:
Device: video stylet
Group- fiberoptic intubation (FO)
Active Comparator group
Description:
: intubation will be done using fiberoptic device by the same anesthesiologist in lateral position
Treatment:
Device: fiberoptic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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