Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03423563
Status:
COMPLETED
Last Update Posted:
2018-03-16
First Post:
2017-12-26
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
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 endoscopeFIVE 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 endoscopeFIVE has become a good alternative and associated with better visualization of laryngeal structures in shorter time as compared to traditional flexible fiberoptic bronchoscopy
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 endoscopeFIVE 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 endoscopeFIVE 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 isnt 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 cant 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 problemsSince 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 cant intubate but can ventilate scenarios Fibreoptic intubation can be a hard skill to teach gain and keepIn 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
If a clear airway cant 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 problemsSince 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 cant intubate but can ventilate scenarios Fibreoptic intubation can be a hard skill to teach gain and keepIn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None