Obstructive Sleep ApneaNCT03313947
Airway Ultrasound Prediction and Correlation
A study testing Ultrasound and Questionnaire in people with Obstructive Sleep Apnea and Difficult Airway, run by Vidya Raman at 1 site in United States.
Trial summary
This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Obstructive Sleep Apnea, Difficult Airway
- What is being tested?
- Ultrasound and Questionnaire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 25 Mar 2020
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children presenting for surgery at NCH ranging in age from 3-12 years
Who cannot join
- Parent/ patient refusal to participate in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea
This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.
- Conditions
- Obstructive Sleep Apnea, Difficult Airway
- Being tested
- Ultrasound, Questionnaire
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).
QuestionnaireOther
The following 6 questions will be asked during the preoperative visit:
- While sleeping, does your child snore more than half the time?
- While sleeping, does your child always snore?
- Have you ever seen your child stop breathing during the night?
- Does your child occasionally wet the bed?
- Did your child stop growing at a normal rate at any time since birth?
- Is your child overweight
| Study group | Role | What they receive |
|---|---|---|
| Difficult Airway | Other | Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral). Receives: Procedure: Ultrasound |
| Obstructive Sleep Apnea | Other | Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral). Receives: Procedure: Ultrasound |
| Predictive Obstructive Sleep Apnea | Other | The following 6 questions will be asked during the preoperative visit:
1. While sleeping, does your child snore more than half the time?
2. While sleeping, does your child always snore?
3. Have you ever seen your child stop breathing during the night?
4. Does your child occasionally wet the bed?
5. Did your child stop growing at a normal rate at any time since birth?
6. Is your child overweight Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyo-mental distance
The distance from the hyoid bone to the mentum to predict difficult airway.
Measured: 5 minutes before surgery starts
Secondary outcomes (3)
Tongue width
Width of the tongue between the lingual arteries.
Measured: 5 minutes after being intubated in surgery
Tonsil size
Size of tonsil (bilateral)
Measured: 5 minutes after being intubated in surgery
Questionnaire
6 predictive OSA questions
Measured: 30 minutes before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start25 Mar 2020
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Why it stopped: PI was unable to perform ultrasound of airway.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vidya Raman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vidya Raman, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313947
- Sponsor's protocol ID
- IRB17-00436
- Status last verified
- Apr 2020
- First submitted
- 16 Oct 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Ultrasound to Predict Obstructive Sleep Apnea Syndrome in Children and Its Correlation With Clinical Signs and Symptoms of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03313947
- Acronym / sponsor ID
- IRB17-00436
- Conditions
- Obstructive Sleep Apnea, Difficult Airway
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI was unable to perform ultrasound of airway.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 18 Oct 2017 (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.
This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Difficult Airway | Other | Procedure: UltrasoundUltrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral). |
| Obstructive Sleep Apnea | Other | Procedure: UltrasoundUltrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral). |
| Predictive Obstructive Sleep Apnea | Other | Other: QuestionnaireThe following 6 questions will be asked during the preoperative visit: 1. While sleeping, does your child snore more than half the time? 2. While sleeping, does your child always snore? 3. Have you ever seen your child stop breathing during the night? 4. Does your child occasionally wet the bed? 5. Did your child stop growing at a normal rate at any time since birth? 6. Is your child overweight |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children presenting for surgery at NCH ranging in age from 3-12 years
Key exclusion criteria (1 listed)
- Parent/ patient refusal to participate in study
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 |
|---|---|---|
| UltrasoundUltrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral). | Procedure or surgery | Difficult Airway, Obstructive Sleep Apnea |
| QuestionnaireThe following 6 questions will be asked during the preoperative visit: 1. While sleeping, does your child snore more than half the time? 2. While sleeping, does your child always snore? 3. Have you ever seen your child stop breathing during the night? 4. Does your child occasionally wet the bed? 5. Did your child stop growing at a normal rate at any time since birth? 6. Is your child overweight | Other | Predictive Obstructive Sleep Apnea |
Primary outcome
Hyo-mental distance
Time frame: 5 minutes before surgery starts
The distance from the hyoid bone to the mentum to predict difficult airway.
3 secondary outcomes
Tongue width
Time frame: 5 minutes after being intubated in surgery
Tonsil size
Time frame: 5 minutes after being intubated in surgery
Questionnaire
Time frame: 30 minutes before surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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?
A study testing Ultrasound and Questionnaire in people with Obstructive Sleep Apnea and Difficult Airway, run by Vidya Raman at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 7 Apr 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hyo-mental distance (time frame: 5 minutes before surgery starts). 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 7 Apr 2020.