Visual Examination of Airway Via Flexible Fiberoptic Scope After Cervical Spine Surgery

NCT06230315 | Completed DMC

• 1 other identifier: 905477-11
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Airway swelling and edema after cervical spine surgery(CSS) 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

Conditions

Airway Edema

Keywords

leak test; cervical spine surgery

Outcome Measures

Primary Outcomes (1)

• Degree of airway swelling - subglottic and supraglottic

  Surgical time and number of levels involved in surgery as factors affecting degree of airway swelling.

  24 hours

Secondary Outcomes (1)

• Degree of airway swelling - subglottic and supraglottic

  24 hours

Study Arms (1)

Cervical spine surgery patients

Patients undergoing multilevel cervical spine surgery at Upstate University hospital

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing multilevel cervical spine surgery are recruited as study subjects. Inclusion and exclusion criteria as described above

You may qualify if:

• Adult patient age 18-70 years.
• Elective cervical spine surgeries involving in upper CSS, ≥ 2 levels, surgical duration ≥ 2 hours
• ASA class \<4

You may not qualify if:

• RSI (rapid-sequence induction) and patients with high aspiration risk (postpartum).
• Emergency surgery
• Angioedema
• History of airway malignancy.
• Recent upper airway surgery.
• Significant recent upper airway infection or abscess.
• History of radiation therapy
• Nasogastric tube in place.
• Tracheostomy in place.
• History of basal skull fracture or extensive maxillofacial fracture.
• Severe nasal septum deviation.
• Morbid obesity BMI \> 40.
• Surgery involves in C1.
• History of epistaxis or bleeding disorder

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

Suny Upstate Medical University

Syracuse, New York, 13210, United States

Location

Study Officials

• Luay Nubani, MBCHB

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: January 30, 2024
• Study Start: November 1, 2016
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)