StridorNCT02244697
The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children
An observational study of Stridor and Vocal Cord Paralysis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal cord paralysis. Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of laryngomalacia. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Stridor, Vocal Cord Paralysis
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Apr 2016
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.
Who may be able to join
- children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Shirley Friedman, Doctor contact
About this study
Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal cord paralysis.
Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient and the laryngeal view may be obscured due to patient movement or anatomical variations.
Read more
Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of laryngeal adduction.
The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric population.
- Conditions
- Stridor, Vocal Cord Paralysis
- Keywords
- Stridor, Vocal Cord Paralysis (VCP), Ultrasound (US)
- Medical subject headings
- Respiratory Sounds, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: laryngeal ultrasound stridor | Children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre. | |
| Other: laryngeal ultrasound -control | Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL
i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc.
Measured: 2014-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StridorStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shirley Friedman, Doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244697
- Sponsor's protocol ID
- TASMC-14-FS-0191-CTIL
- Status last verified
- Sep 2014
- First submitted
- 2 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Yield of Laryngeal Ultrasound in the Evaluation of Stridor and Dysphonia in Children
- ClinicalTrials.gov ID
- NCT02244697
- Acronym / sponsor ID
- TASMC-14-FS-0191-CTIL
- Conditions
- Stridor, Vocal Cord Paralysis
- Keywords
- Stridor, Vocal Cord Paralysis (VCP), Ultrasound (US)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- 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.
Stridor is a respiratory noise caused by partial obstruction of the large airways at the level of the pharynx, larynx and/or trachea. The second most common cause of stridor is vocal cord paralysis.
Awake nasolaryngoscopyn (ANL) is regarded as the gold standard for the diagnosis of laryngomalacia. However, ANL has some drawbacks as it may cause discomfort for the patient and the laryngeal view may be obscured due to patient movement or anatomical variations.
Ultrasound (US) is a noninvasive, painless, radiation free, well tolerated imaging technique. Evaluation of the dynamic characteristics of the glottis by US revealed perfect reliability in comparison to nasolryngoscopy suggesting that US can be useful in the assessment of laryngeal adduction.
The investigator hypothesize that laryngeal US can be an accurate and reliable adjunct in the diagnosis of functional and anatomical causes of stridor and dysphonia in the pediatric population.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: laryngeal ultrasound stridor | – | –Children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre. |
| Other: laryngeal ultrasound -control | – | –Infants matched for age referred for ANL for reasons other than stridor will undergo US of the larynx. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.
Key inclusion criteria (1 listed)
- children aged 0-16 years referred for an awake nasolaryngoscopy for stridor or dysphonia at the pediatric Otolaryngology unit at the Tel Aviv Sourasky Medical Centre will undergo US of the larynx.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL
Time frame: 2014-2016
i.e. vocal cord nodules, vocal cord paralysis, vocal cord cyst etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
Shirley Friedman, Doctor contact
Shirley Friedman, Doctor principal investigator
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 Stridor and Vocal Cord Paralysis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 19 Sep 2014. 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 Israel. 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?
Contact Shirley Friedman, Doctor (shirfri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants that will be diagnosed with anatomical and functional causes of stridor and dysphonia by US in comparisom with ANL (time frame: 2014-2016). 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 19 Sep 2014.