Intubating Video Stylet Versus Fiberoptic Intubating Bronchoscope.

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04183959

Collaborator

Theodor Bilharz Research Institute (Other)

Enrollment

Location

Arms

7.6

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubating Video Stylet	Device: video stylet Device: fiberoptic	N/A

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

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 3, 2019

Actual Primary Completion Date :

Jun 16, 2020

Actual Study Completion Date :

Jul 22, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group- video stylet intubation (VS)

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

Device: video stylet

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

Active Comparator: Group- fiberoptic intubation (FO)

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

Device: fiberoptic

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

Outcome Measures

Primary Outcome Measures

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

Intubation success rate [up to 1 hour]
Intubation success rate
Number of intubation attempts [up to 1 hour]
Number of intubation attempts
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Cairo University.	Cairo		Egypt	11451

Sponsors and Collaborators

Cairo University
Theodor Bilharz Research Institute

Investigators

Principal Investigator: Nesrine Elrefai, MD, Professor of Anaesthesia, surgical ICU &Pain management
Principal Investigator: Sohaila Omar, MD, Professor of Anaesthesia and surgical ICU
Study Director: Mohamed Hussien, MD, Lecturer of Anaesthesia and surgical ICU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University

ClinicalTrials.gov Identifier:

NCT04183959

Other Study ID Numbers:

MD-53-2019

First Posted:

Dec 3, 2019

Last Update Posted:

Jul 30, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 30, 2020