Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

Not Applicable

Completed

• Conditions: Intubating Video Stylet
• Interventions: Device: video stylet; Device: fiberoptic

• Registration Number: NCT04183959
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2019-12-02
• Study Start: 2019-12-03
• Study First Posted: 2019-12-03
• Primary Completion: 2020-06-16
• Status Verified: 2020-07
• Study Completion: 2020-07-22
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intubation time	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 Outcome Measures

Name	Time	Method
Number of intubation attempts	up to 1 hour	Number of intubation attempts
Intubation success rate	up to 1 hour	Intubation success rate
Hemodynamic stability	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)

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University.; 🇪🇬 Cairo, Egypt