Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery

NCT03764904 | Unknown

• 1 other identifier: FMASU R 68 /2018
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

literature on use of the ultrasound (US) in extubation decisions in cervical spine surgery is scarce.The aim of this study will be to evaluate the utility of US as an aid for decision making for extubation in elective cervical spine surgery (anterior approach) operations and as a predictor for postextubation stridor in these operations

Conditions

Postextubation Stridor

Outcome Measures

Primary Outcomes (1)

• the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor

  At the end of operation, laryngeal air column width \[which is defined as the width of air between the vocal cords as demonstrated by US\] will be obtained while the tube cuff is inflated then while it is deflated for three consecutive respiratory cycles after gentle suction of oropharyngeal airway. The laryngeal air-column width difference \[LACWD\] (the difference between width at balloon-cuff deflation and at balloon-cuff inflation) will be obtained and the average value will be recorded. Patient will be considered ready for extubation after performance of the cuff-leak test as \[the volume of reduced cuff leak test is more than 110 ml\] then reversal of neuromuscular blockade will be done. They tube will be removed when the patients can open their eyes on verbal commands and the T4/T1 ratio is 90% or more. After transferal of patients ICU where they will be observed for occurrence of postextubation stridor in the first 6 hour postoperatively.

  First 6 hours postoperatively

Secondary Outcomes (1)

• Incidence of other airway complication as hematoma

  Intraoperative pre-extubation

Interventions

Airway Ultrasound RADIATION

Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Thirty patients aged 18-60 years ASA Ⅰ and Ⅱ of both genders who are scheduled for elective anterior cervical surgery under general anesthesia in supine position for the first time will be enrolled in the study.

You may qualify if:

• surgeries associated with either exposure of more than three vertebral bodies,
• exposures involving the C2-C4 levels,
• blood loss exceeding 300 mL
• surgical time of more than five hours,

You may not qualify if:

• laryngotracheobronchial pathology,
• severe cardiorespiratory disease,
• admitted for redo-surgery
• intubated prior to operation
• Patient with anesthetic risk factors include Mallampati 3 or 4 and multiple intubation attempts

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: December 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 6, 2018

Record last verified: 2018-12

Locations

EG (1)