Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03764904
Other study ID # FMASU R 68 /2018
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date March 2019

Study information

Verified date December 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date March 2019
Est. primary completion date February 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- 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,

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Airway Ultrasound
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.

Locations

Country Name City State
Egypt Ain Shams University hospitals Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Incidence of other airway complication as hematoma Intraoperative pre-extubation