Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230315
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2018-09-05
Brief Title:
Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Direct Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery
Status:
COMPLETED
Status Verified Date:
2024-01
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:
Airway swelling and edema after cervical spine surgeryCSS especially in prone position is the direct cause that prohibits patient from extubation Anterior cervical discectomy and fusion causes severe peri-vertebral soft tissue swelling that was associated with increased postoperative airway complications
Facial lip and tongue edema in combination with the cuff leak test and risk factors are currently served as the bases on whether patient can be extubated after spine surgery Direct visualization of the larynx and inside trachea post-operatively to assess the airway directly using flexible fiberoptic scope as well as to quantify the degree of airway edema has not been investigated
Investigators are comparing airway before and after cervical spine surgery for any degree of narrowing in the airway using flexible fiberoptic scope Investigators are also studying the risk factors affecting the degree of narrowing in the airway if any
Facial lip and tongue edema in combination with the cuff leak test and risk factors are currently served as the bases on whether patient can be extubated after spine surgery Direct visualization of the larynx and inside trachea post-operatively to assess the airway directly using flexible fiberoptic scope as well as to quantify the degree of airway edema has not been investigated
Investigators are comparing airway before and after cervical spine surgery for any degree of narrowing in the airway using flexible fiberoptic scope Investigators are also studying the risk factors affecting the degree of narrowing in the airway if any
Detailed Description:
Because direct visualization of the airway is the most reliable way for the diagnosing and assessing the degree of laryngeal and trachea edema or swelling investigators sought to do a study to evaluate the degree of airway edema in adult patients undergoing for CSS using direct visualization via flexible fiberoptic and compare the results pre and post- operatively
The primary outcome will be severity of larynx and trachea edema after cervical spine surgery
Secondary outcome will be assessment of reliability of airway leak technique and association between face swelling and airway edema
18 years old and above 63 number of patient will be enrolled in the study Patient enrolled who are under going elective cervical spine surgeryPatients involved in the study will be taken to the OR after induction and prior to intubation asleep flexible fiberoptic scope will be inserted nasally and video record will be taken above and below the glottis surgery will be continued as planned
The primary analysis is to test the association of the severity of the laryngeal and tracheal edema with surgical time and number of levels involved in surgery Investigators will also perform an exploratory analysis to examine the impact of other potential risk factor including age fluids and blood products transfusions ASA American Society of Anesthesiology physical status facial swelling and cuff leak After conclusion of surgery and when patients are ready for extubation Quantitative cuff leak will be done flexible fiber optic scope will be placed through the endotracheal tube and at the same time of extubation fiber optic scope will be pulled slowly with the endotracheal tube while recording video until we reach a point that approximate same point video was taken prior to intubation patients who will remain intubated nasal scope will be placed and video will be taken above the glottis with the endotracheal tube in place another video will be taken for the airway from inside the endotracheal tube
Study will be aborted if significant resistance during placement of the fiberoptic scope nasal bleeding happens or hypoxemia requiring ventilation
Pictures will be saved on USB device and will be assigned a random code that is non-leading to which videos were taken before surgery and which were taken after surgery Recording prior to intubation will be done as we are withdrawing the scope out so the motion will be similar to the motion in the video recorded with extubation hoping that this will be less leading to the blinded ENT surgeon to which was taken before and which after Patient that will be kept intubated are not blinded
Pictures will be then shown to ENT surgeon to assess and compare preoperative and postoperative outcome
Severity of the laryngeal tracheal edema is classified into mild moderate and severe According to the reduction of the cross-section of the trachea lumen Mild edema is defined as reduction 30 Moderate 50 severe 50 8
ENT surgeon will grade the degree of narrowing in the trachea to
1 No edema to 30
2 31-50
3 50
And above the trachea into
1 none
2 mild
3 severe
The primary outcome will be severity of larynx and trachea edema after cervical spine surgery
Secondary outcome will be assessment of reliability of airway leak technique and association between face swelling and airway edema
18 years old and above 63 number of patient will be enrolled in the study Patient enrolled who are under going elective cervical spine surgeryPatients involved in the study will be taken to the OR after induction and prior to intubation asleep flexible fiberoptic scope will be inserted nasally and video record will be taken above and below the glottis surgery will be continued as planned
The primary analysis is to test the association of the severity of the laryngeal and tracheal edema with surgical time and number of levels involved in surgery Investigators will also perform an exploratory analysis to examine the impact of other potential risk factor including age fluids and blood products transfusions ASA American Society of Anesthesiology physical status facial swelling and cuff leak After conclusion of surgery and when patients are ready for extubation Quantitative cuff leak will be done flexible fiber optic scope will be placed through the endotracheal tube and at the same time of extubation fiber optic scope will be pulled slowly with the endotracheal tube while recording video until we reach a point that approximate same point video was taken prior to intubation patients who will remain intubated nasal scope will be placed and video will be taken above the glottis with the endotracheal tube in place another video will be taken for the airway from inside the endotracheal tube
Study will be aborted if significant resistance during placement of the fiberoptic scope nasal bleeding happens or hypoxemia requiring ventilation
Pictures will be saved on USB device and will be assigned a random code that is non-leading to which videos were taken before surgery and which were taken after surgery Recording prior to intubation will be done as we are withdrawing the scope out so the motion will be similar to the motion in the video recorded with extubation hoping that this will be less leading to the blinded ENT surgeon to which was taken before and which after Patient that will be kept intubated are not blinded
Pictures will be then shown to ENT surgeon to assess and compare preoperative and postoperative outcome
Severity of the laryngeal tracheal edema is classified into mild moderate and severe According to the reduction of the cross-section of the trachea lumen Mild edema is defined as reduction 30 Moderate 50 severe 50 8
ENT surgeon will grade the degree of narrowing in the trachea to
1 No edema to 30
2 31-50
3 50
And above the trachea into
1 none
2 mild
3 severe
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?:
None
Is an FDA AA801 Violation?:
None