Airway Ultrasound Prediction and Correlation

NCT ID: NCT03313947

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-25

Study Completion Date

2020-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Difficult Airway

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Difficult Airway

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).

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

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).

Obstructive Sleep Apnea

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).

Group Type OTHER

Ultrasound

Intervention Type PROCEDURE

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).

Predictive Obstructive Sleep Apnea

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

Group Type OTHER

Questionnaire

Intervention Type 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

Interventions

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Ultrasound

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).

Intervention Type PROCEDURE

Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All children presenting for surgery at NCH ranging in age from 3-12 years

Exclusion Criteria

* Parent/ patient refusal to participate in study
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vidya Raman

OTHER

Sponsor Role lead

Responsible Party

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Vidya Raman

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-00436

Identifier Type: -

Identifier Source: org_study_id

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