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Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183959
Enrollment
50
Registered
2019-12-03
Start date
2019-12-03
Completion date
2020-07-22
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubating Video Stylet

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.

Interventions

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

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

Sponsors

Theodor Bilharz Research Institute
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Intubation timeup 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

MeasureTime frameDescription
Intubation success rateup to 1 hourIntubation success rate
Number of intubation attemptsup to 1 hourNumber of intubation attempts
Hemodynamic stabilityup to 1 hourassessed 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026