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WithdrawnNCT02227134Updated Jul 10, 2020

Ultrasound to Predict a Pediatric Difficult Airway and Obstructive Sleep Apnea Syndrome in Children

An interventional study of Ultrasound in Difficult Airway and Obstructive Sleep Apnea, sponsored by Vidya Raman. Withdrawn at 1 site in United States. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-10.

Sponsored by Vidya Raman · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Unable to perform the ultrasound.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
1 Month to 18 Years
Sex
All
01

Study summary

This is a prospective study to see whether ultrasonography can predict difficult airway and/or predict obstructive sleep apnea syndrome (OSAS) in children.

02

Conditions studied

  • Difficult Airway
  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Vidya Raman is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Parent/ patient refusal to participate in study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Difficult Airway

    Children with a history of difficult airway intubation.

    Procedure: Ultrasound

  • Other
    Obstructive Sleep Apnea

    Children with a history of obstructive sleep apnea.

    Procedure: Ultrasound

Interventions

  • ProcedureUltrasound

    Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.

06

What researchers measure

Primary outcomes

  1. Hyo-mental distance

    The distance from the hyoid bone to the mentum to predict difficult airway.

    Time frame: intraoperative

Secondary outcomes

  1. Tongue width

    Width of the tongue between the lingual arteries.

    Time frame: intraoperative

  2. Tonsil Size

    Size of tonsil (bilateral)

    Time frame: intraoperative

07

Study locations

1 site
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02227134
Lead sponsor
Vidya Raman
Responsible party
Vidya Raman (Clinical Assistant Professor, Nationwide Children's Hospital) — Sponsor-investigator
First posted
Aug 27, 2014
Start date
Feb 2015
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jul 10, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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