NCT03834597

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

February 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 6, 2019

Last Update Submit

February 6, 2019

Conditions

Complication, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Vocal cord dysfunction

    newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status.

    Intraoperative

Secondary Outcomes (1)

  • Incidence of traumatic complications

    First 24 hours postoperatively

Interventions

conventional Macintosh laryngoscopeDEVICE

After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.

GlideScope®DEVICE

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective thyroid surgery

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I and II,
  • Elective thyroid surgery with
  • Normal thyroid profile

You may not qualify if:

  • History of previous thyroid surgery,
  • Preoperative vocal cord dysfunction
  • Predicted difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

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

February 6, 2019

First Posted

February 8, 2019

Study Start

February 6, 2019

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

EG(1)