Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

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

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.

Study Overview

• Status: Completed
• Conditions: Intubating Video Stylet
• Intervention / Treatment: Device: video stylet; Device: fiberoptic

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Faculty of Medicine, Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group- video stylet intubation (VS); trachea will be intubated using laryngoscopic assisted video stylet device in lateral position	Device: video stylet; trachea will be intubated using laryngoscopic assisted video stylet device in lateral position
ACTIVE_COMPARATOR: Group- fiberoptic intubation (FO); : intubation will be done using fiberoptic device by the same anesthesiologist in lateral position	Device: fiberoptic; intubation will be done using fiberoptic device by the same anesthesiologist in lateral position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation success rate	Intubation success rate	up to 1 hour
Number of intubation attempts	Number of intubation attempts	up to 1 hour
Hemodynamic stability	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)	up to 1 hour

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Theodor Bilharz Research Institute
• Investigators: Principal Investigator: Nesrine Elrefai, MD, Professor of Anaesthesia, surgical ICU &Pain management; Principal Investigator: Sohaila Omar, MD, Professor of Anaesthesia and surgical ICU; Study Director: Mohamed Hussien, MD, Lecturer of Anaesthesia and surgical ICU

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2019
• Primary Completion (ACTUAL): June 16, 2020
• Study Completion (ACTUAL): July 22, 2020

Study Registration Dates

• First Submitted: November 29, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (ACTUAL): December 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MD-53-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Still working

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No