Comparison of Endotracheal Intubation Using Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope (FIVE) in Obese Patients Undergoing Elective Surgeries Under General Anesthesia: A Randomized Controlled Trial
NCT03423563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2018-03-16
Summary
Tracheal intubation is one of the most common medical procedures performed in hospitals. On one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This disastrous outcome happens when the airway cannot be secured by intubation and face mask ventilation becomes difficult.
Careful preoperative evaluation to identify patients in whom tracheal intubation and mask ventilation may prove to be difficult can save lives.
Over the past 40 years, different techniques of tracheal intubation have been introduced, the most effective under different conditions being fiberoptic intubation.
The flexible intubation video endoscope is a relatively new device which delivers clear, pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a full-format direct video imaging with improved image quality with a resolution higher than fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be broken or have transmission loss when wrapped around curves of only a few centimeters radius.
After ethics approval and informed consent from patients, 60 obese patients aging from 20-60 years will randomly allocated and divided into two groups each is (Thirty) patients in each group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic bronchoscopy in (group 2).
The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR) changes, success rate, number of attempts and complications in both groups.
investigators expect from this study that flexible intubation video endoscope(FIVE) has become a good alternative and associated with better visualization of laryngeal structures in shorter time as compared to traditional flexible fiberoptic bronchoscopy.
Conditions
- Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
Interventions
- DEVICE
-
Flexible fiberoptic bronchoscopy
Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients
- DEVICE
-
Fexible intubation video endoscopy
Fexible intubation video endoscopy
Sponsors & Collaborators
-
Mohamed, Ahmed A., M.D.
collaborator INDIV -
Mai Wedad Ahmed
collaborator UNKNOWN -
Norhan Abdelaleem Ali
collaborator UNKNOWN -
Magdy Abdelmohsen Elsayed
collaborator UNKNOWN -
Atef Kamel Salama
collaborator UNKNOWN -
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-01-04
- Primary Completion
- 2018-02-05
- Completion
- 2018-02-11
Countries
- Egypt
Study Locations
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