Difficult AirwayNCT02227134
Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
A study testing Ultrasound in people with Difficult Airway and Obstructive Sleep Apnea, run by Vidya Raman at 1 site in United States.
Trial summary
This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Difficult Airway, Obstructive Sleep Apnea
- What is being tested?
- Ultrasound
- 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
- Feb 2015to Dec 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.
- Children with difficult tracheal intubation aged 1 month - 18 years old
- Children with obstructive sleep apnea aged 1 year - 8 years old
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
This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.
- Conditions
- Difficult Airway, Obstructive Sleep Apnea
- Being tested
- Ultrasound
- 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, tonsil size and width of the tongue.
| Study group | Role | What they receive |
|---|---|---|
| Difficult Airway | Other | Children with a history of difficult airway intubation. Receives: Procedure: Ultrasound |
| Obstructive Sleep Apnea | Other | Children with a history of obstructive sleep apnea. Receives: Procedure: Ultrasound |
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: intraoperative
Secondary outcomes (2)
Tongue width
Width of the tongue between the lingual arteries.
Measured: intraoperative
Tonsil Size
Size of tonsil (bilateral)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Unable to perform the ultrasound.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies 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
- Single group
- 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
- NCT02227134
- Sponsor's protocol ID
- IRB14-00572
- Status last verified
- Jul 2020
- First submitted
- 26 Aug 2014
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children
- ClinicalTrials.gov ID
- NCT02227134
- Acronym / sponsor ID
- IRB14-00572
- Conditions
- Difficult Airway, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to perform the ultrasound.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vidya RamanUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Aug 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.
This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difficult Airway | Other | Procedure: UltrasoundChildren with a history of difficult airway intubation. |
| Obstructive Sleep Apnea | Other | Procedure: UltrasoundChildren with a history of obstructive sleep apnea. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children with known or suspected difficult direct laryngoscopy identified by either ENT or anesthesiologist.
- Children with difficult tracheal intubation aged 1 month - 18 years old
- Children with obstructive sleep apnea aged 1 year - 8 years old
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, tonsil size and width of the tongue. | Procedure or surgery | Difficult Airway, Obstructive Sleep Apnea |
Primary outcome
Hyo-mental distance
Time frame: intraoperative
The distance from the hyoid bone to the mentum to predict difficult airway.
2 secondary outcomes
Tongue width
Time frame: intraoperative
Tonsil Size
Time frame: intraoperative
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 10 Jul 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 in people with Difficult Airway and Obstructive Sleep Apnea, 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 3 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 10 Jul 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: 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 10 Jul 2020.