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Completed

NCT Number: NCT04183959

Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

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.

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Key information

Conditions

Intubating Video Stylet

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video stylet

Device

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

fiberoptic

Device

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

Primary outcomes

  1. Intubation time

    Time frame: up to 1 hour

    (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

Secondary outcomes

  1. Intubation success rate

    Time frame: up to 1 hour

    Intubation success rate

  2. Number of intubation attempts

    Time frame: up to 1 hour

    Number of intubation attempts

  3. Hemodynamic stability

    Time frame: up to 1 hour

    assessed based on MAP and HR, which will be measured at the following time intervals: before induction of anesthesia at baseline (BA), after induction of anesthesia but before tracheal intubation (T1), and immediately after successful intubation (T2)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Theodor Bilharz Research Institute

Registry information

Official study title

Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope. A Randomised Comparative Study for Intubation in Lateral Position.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2019
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.