Clinical trial NCT04183959: Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.
Official title: Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope. A Randomised Comparative Study for Intubation in Lateral Position.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubating Video Stylet
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
First posted: 2019-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intubation time
timeFrame: up to 1 hour
Secondary outcomes:
measure: Intubation success rate
timeFrame: up to 1 hour
measure: Number of intubation attempts
timeFrame: up to 1 hour
measure: Hemodynamic stability
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
affiliation: Professor of Anaesthesia, surgical ICU &Pain management
name: Nesrine Elrefai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Anaesthesia and surgical ICU
name: Sohaila Omar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Anaesthesia and surgical ICU
name: Mohamed Hussien, MD
role: STUDY_DIRECTOR
References: