- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764904
Airway Ultrasound as a Predictor for Postextubation Stridor in Anterior Cervical Spine Surgery
Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11591
- Ain Shams University hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the correlation between the post procedural laryngeal air-column width difference [LACWD] as obtained by laryngeal US with occurrence of postextubation stridor
Time Frame: First 6 hours postoperatively
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of other airway complication as hematoma
Time Frame: Intraoperative pre-extubation
|
Intraoperative pre-extubation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU R 68 /2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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