Vocal Cord DysfunctionNCT04140799
Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries
An observational study of Vocal Cord Dysfunction, run by Zagazig University at 1 site in Egypt.
Trial summary
Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Dysfunction
- What is being tested?
- vocal cord ultrasonography
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2019to 15 Feb 2020
- How long will I take part?
- 3 Months
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Egyptian population scheduled for anterior cervical surgeries
Who may be able to join
- Patient acceptance.
- Both sex
- Age (21-60) years old.
- American Society of Anesthesiologist I / II
- Elective anterior cervical spine surgeries
- patient With Body Mass index (25-35 kg/m²)
Who cannot join
- Patient refusal.
- Altered mental status.
- Patients with per-existing neurological or thyroid disease affecting vocal cord function.
- Patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer.
- Patient with a history of thyroidectomy affecting recurrent laryngeal nerve.
- Patient with a history of laryngeal trauma.
- Pre-operative voice abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study
- Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. The standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an alternative tool.
Read the detailed description
- Design: A prospective cohort study.
- Sample size: Assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence interval 95% and power of test is 80%.
All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.
- Conditions
- Vocal Cord Dysfunction
- Being tested
- vocal cord ultrasonography
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vocal cord ultrasonographyDevice
assess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach
The predictive performance of postoperative vocal cord edema and paralysis using the conventional middle and lateral approach of trans cutaneous laryngeal ultrasound will be evaluated using sensitivity, specificity and accuracy . the gold standard for diagnosis of vocal cord edema and paralysis will be the rigid laryngoscopy
Measured: at the end of the first 48 hours after the surgery
Secondary outcomes (2)
Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound
The diagnostic performance of postoperative vocal cord paralysis using the trans cutaneous laryngeal ultrasound for diagnosis of recovery of vocal cord paralysis , among subject with vocal cord paralysis
Measured: At 2 weeks and 3 months after the surgery
The patient discomfort to procedure
The patient discomfort to sonography and rigid laryngoscopy by Discomfort score(Visual analogue scale (VAS)) regarding the amount of discomfort experienced during the procedure. Discomfort was reported by placing a mark on a 10-cm line, with the ends representing "not at all uncomfortable" and "extremely uncomfortable."
Measured: at the end of first 48 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start16 Jan 2019
- Primary completion1 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal Cord DysfunctionStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa A Kamel, M.D, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140799
- Sponsor's protocol ID
- 5645
- Status last verified
- Jun 2020
- First submitted
- 16 Oct 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamel AAF, Amin OAI, Hassan MAMM, Elmesallamy WAEA, Hassan EM. Ultrasound prediction for vocal cord dysfunction in patients scheduled for anterior cervical spine surgeries: a prospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):869-875. doi: 10.1007/s10877-020-00546-3. Epub 2020 Jun 15.
PubMed 32556843
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04140799
- Acronym / sponsor ID
- 5645
- Conditions
- Vocal Cord Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 28 Oct 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.
- Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as 22%. The standard technique for vocal cord evaluation and the most commonly used tool is direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an alternative tool.
Detailed description
- Design: A prospective cohort study.
- Sample size: Assuming that the target population is 240 and positive predictive value of transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence interval 95% and power of test is 80%.
All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience of at least three years in ultrasonography scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Egyptian population scheduled for anterior cervical surgeries
Key inclusion criteria (6 listed)
- Patient acceptance.
- Both sex
- Age (21-60) years old.
- American Society of Anesthesiologist I / II
- Elective anterior cervical spine surgeries
Key exclusion criteria (7 listed)
- Patient refusal.
- Altered mental status.
- Patients with per-existing neurological or thyroid disease affecting vocal cord function.
- Patients with a diagnosis of primary untreated laryngeal/hypopharyngeal cancer.
- Patient with a history of thyroidectomy affecting recurrent laryngeal nerve.
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 |
|---|---|---|
| vocal cord ultrasonographyassess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries | Device | – |
Primary outcome
Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach
Time frame: at the end of the first 48 hours after the surgery
The predictive performance of postoperative vocal cord edema and paralysis using the conventional middle and lateral approach of trans cutaneous laryngeal ultrasound will be evaluated using sensitivity, specificity and accuracy . the gold standard for diagnosis of vocal cord edema and paralysis will be the rigid laryngoscopy
2 secondary outcomes
Diagnostic performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound
Time frame: At 2 weeks and 3 months after the surgery
The patient discomfort to procedure
Time frame: at the end of first 48 hour postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 32556843Kamel AAF, Amin OAI, Hassan MAMM, Elmesallamy WAEA, Hassan EM. Ultrasound prediction for vocal cord dysfunction in patients scheduled for anterior cervical spine surgeries: a prospective cohort study. J Clin Monit Comput. 2021 Aug;35(4):869-875. doi: 10.1007/s10877-020-00546-3. Epub 2020 Jun 15.
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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.
Alshaimaa A Kamel, M.D principal investigator
Zagazig University
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 Vocal Cord Dysfunction, run by Zagazig 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Predictive performance associated with the postoperative quantitative trans-cutaneous laryngeal ultrasound: conventional middle approach compared to lateral approach (time frame: at the end of the first 48 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140799, which also lists 1 linked publication.
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 30 Jun 2020.