Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

NCT ID: NCT04183959

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-03
• Study Completion Date: 2020-07-22

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.

Conditions

Intubating Video Stylet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Group- video stylet intubation (VS)

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

Group Type: ACTIVE_COMPARATOR

video stylet

Intervention Type: DEVICE

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

Group- fiberoptic intubation (FO)

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

Group Type: ACTIVE_COMPARATOR

fiberoptic

Intervention Type: DEVICE

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

Interventions

video stylet

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

Intervention Type: DEVICE

fiberoptic

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesrine Elrefai, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Anaesthesia, surgical ICU &Pain management

Sohaila Omar, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Anaesthesia and surgical ICU

Mohamed Hussien, MD

Role: STUDY_DIRECTOR

Lecturer of Anaesthesia and surgical ICU

Locations

Faculty of Medicine, Cairo University.

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MD-53-2019

Identifier Type: -

Identifier Source: org_study_id