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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03834597
Other study ID # FMASU R 08/2019
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 6, 2019
Est. completion date June 2019

Study information

Verified date February 2019
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vocal cord dysfunction is a serious post-thyroidectomy complication. This can lead to various postoperative clinical consequences as hoarseness of voice, aspiration or stridor . It is also one of the common reasons for post-thyroidectomy malpractice claims.

This study will compare GlideScope® with Macintosh laryngoscope regarding accuracy of assessment of post-thyroidectomy vocal cord mobility.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date June 2019
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical status I and II,

- Elective thyroid surgery with

- Normal thyroid profile

Exclusion Criteria:

- History of previous thyroid surgery,

- Preoperative vocal cord dysfunction

- Predicted difficult airway

Study Design


Intervention

Device:
conventional Macintosh laryngoscope
After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.
GlideScope®
Patient will be left for a while until hemodynamic stabilization then examination with GlideScope® will be commenced to assess postthyroidectomy vocal cord mobility by another experienced anesthesiologist

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 Vocal cord dysfunction newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status. Intraoperative
Secondary Incidence of traumatic complications traumatic complications as swelling in the mouth, tongue, or throat, teeth injury, bleeding or hoarseness of voice First 24 hours postoperatively
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