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
Primary Purpose
Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Flexible fiberoptic bronchoscopy
Fexible intubation video endoscopy
Sponsored by

About this trial
This is an interventional basic science trial for Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
Eligibility Criteria
Inclusion Criteria:
- Age between 20 and 50 years.
- Scheduled for elective surgery requiring endotracheal intubation.
- Patient with ASA physical status I-II.
Exclusion Criteria:
• Unable to give consent
- Patient with ASA physical status more than II.
- Age < 20years old and >50years
- Pregnant patient.
- Known, difficult airway
- Loose teeth
- Require a rapid sequence induction,
- If special endotracheal tube (ETT) is needed for the case.
- Emergency surgeries
Sites / Locations
- Ahmed Abdalla Mohamed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Flexible fiberoptic bronchoscopy
Fexible intubation video endoscopy
Arm Description
Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios
Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor
Outcomes
Primary Outcome Measures
Successful intubation
Time in Minutes of successful intubation.
Secondary Outcome Measures
Rate of first successful intubation
Rate of first time success intubation
Second trial for successful intubation
Intubation success in second trial
Full Information
NCT ID
NCT03423563
First Posted
December 26, 2017
Last Updated
March 14, 2018
Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Mai Wedad Ahmed, Norhan Abdelaleem Ali, Magdy Abdelmohsen Elsayed, Atef Kamel Salama
1. Study Identification
Unique Protocol Identification Number
NCT03423563
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
February 5, 2018 (Actual)
Study Completion Date
February 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Mohamed, Ahmed A., M.D., Mai Wedad Ahmed, Norhan Abdelaleem Ali, Magdy Abdelmohsen Elsayed, Atef Kamel Salama
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Airway management is considered a cardinal aspect of anesthetic practice and of emergency and intensive care medicine. Endotracheal intubation is a simple, safe, rapid and nonsurgical method that achieves all the objectives of airway management which include maintaining a patent airway, lung protection from aspiration and allows leak free ventilation during mechanical ventilation. Even though endotracheal intubation isn't a complication free procedure, some of them life-threatening. It is important to anesthesiologists to be alert to these complications and to have an effective plan to avoid and manage these complications when they occur .
If a clear airway can't be guaranteed, it can be fatal. In 1990, an analysis of anesthesia-related closed claims in the USA declared that respiratory system adverse outcomes were the lone largest class of injury and that the percentage of death or catastrophic brain insult associated with it was much higher than that associated with cardiovascular problems.Since then, it became a priority to decrease the serious adverse outcomes associated with airway management; major protocols for difficult airway management have been defined, developing new reliable airway devices, and adequate monitoring of ventilation by pulse oximetry and capnography have become a standard. Thanks to these efforts, the incidence of these serious adverse outcomes is likely to be reduced, and airway management can now be considered as a safe procedure.
Endotracheal intubation is still the "gold standard" in airway management . If with using traditional techniques or video-assisted techniques which can be used when there is intubation failure or anticipated difficult airway. Video-assisted techniques may help to increase intubation success.
Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor.
Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios . Fibreoptic intubation can be a hard skill to teach, gain and keep.In this context, closed claims analysis has declared severe complications such as catastrophic brain insult and death occurred with anticipated difficult airway management and awake intubation. Therefore, it is considerable to develop simple, dependable, safe, and effective intubation devices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
Masking
None (Open Label)
Masking Description
In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flexible fiberoptic bronchoscopy
Arm Type
Experimental
Arm Description
Fiberoptic intubation has been considered for a long time the gold standard technique for intubation when there is anticipated or known difficult airway or as a rescue device in can't intubate but can ventilate scenarios
Arm Title
Fexible intubation video endoscopy
Arm Type
Experimental
Arm Description
Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber optical or camera chip technique and to show the video picture on an external or built-in monitor
Intervention Type
Device
Intervention Name(s)
Flexible fiberoptic bronchoscopy
Intervention Description
Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients
Intervention Type
Device
Intervention Name(s)
Fexible intubation video endoscopy
Intervention Description
Fexible intubation video endoscopy
Primary Outcome Measure Information:
Title
Successful intubation
Description
Time in Minutes of successful intubation.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Rate of first successful intubation
Description
Rate of first time success intubation
Time Frame
Intraoperative
Title
Second trial for successful intubation
Description
Intubation success in second trial
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 20 and 50 years.
Scheduled for elective surgery requiring endotracheal intubation.
Patient with ASA physical status I-II.
Exclusion Criteria:
• Unable to give consent
Patient with ASA physical status more than II.
Age < 20years old and >50years
Pregnant patient.
Known, difficult airway
Loose teeth
Require a rapid sequence induction,
If special endotracheal tube (ETT) is needed for the case.
Emergency surgeries
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Via scholar Gate
Learn more about this trial
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
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