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

December 4, 2018 updated by: Marwa Ahmed Khairy Elbeialy, Ain Shams University

Airway Ultrasound as a Predictor for Postextubation Stridor in Cervical Spine Surgery [Anterior Approach]: Prospective Observational Study

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

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11591
        • Ain Shams University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

December 4, 2018

Last Verified

December 1, 2018

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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