Complication, PostoperativeNCT03834597
GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility
An observational study of Complication, Postoperative, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Complication, Postoperative
- What is being tested?
- conventional Macintosh laryngoscope and GlideScope®
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2019to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing elective thyroid surgery
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II,
- Elective thyroid surgery with
- Normal thyroid profile
Who cannot join
- History of previous thyroid surgery,
- Preoperative vocal cord dysfunction
- Predicted difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Complication, Postoperative
- Being tested
- conventional Macintosh laryngoscope, GlideScope®
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal cord dysfunction
newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status.
Measured: Intraoperative
Secondary outcomes (1)
Incidence of traumatic complications
traumatic complications as swelling in the mouth, tongue, or throat, teeth injury, bleeding or hoarseness of voice
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start6 Feb 2019
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Khairy Elbeialy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834597
- Sponsor's protocol ID
- FMASU R 08/2019
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope® Versus Macintosh Laryngoscope for Post-thyroidectomy Assessment of Vocal Cord Mobility
- ClinicalTrials.gov ID
- NCT03834597
- Acronym / sponsor ID
- FMASU R 08/2019
- Conditions
- Complication, Postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective thyroid surgery
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I and II,
- Elective thyroid surgery with
- Normal thyroid profile
Key exclusion criteria (3 listed)
- History of previous thyroid surgery,
- Preoperative vocal cord dysfunction
- Predicted difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional Macintosh laryngoscopeAfter closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility. | Device | – |
| 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 | Device | – |
Primary outcome
Vocal cord dysfunction
Time frame: Intraoperative
newly recorded reduction in the postoperative vocal cords mobility compared with the preoperative status.
1 secondary outcome
Incidence of traumatic complications
Time frame: First 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication, Postoperative, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal cord dysfunction (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.