Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope. A Randomised Comparative Study for Intubation in Lateral Position.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Intubation time
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group- video stylet intubation (VS)
trachea will be intubated using laryngoscopic assisted video stylet device in lateral position
Intervention: video stylet (Device)
Group- fiberoptic intubation (FO)
: intubation will be done using fiberoptic device by the same anesthesiologist in lateral position
Intervention: fiberoptic (Device)
Outcomes
Primary Outcomes
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
- Number of intubation attempts(up to 1 hour)
- Intubation success rate(up to 1 hour)
- Hemodynamic stability(up to 1 hour)
Investigators
Amr Samir Wahdan
Lecturer of Anesthesia, Pain management and Surgical ICU
Cairo University