Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

NCT ID: NCT02321956

Last Updated: 2017-06-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

Detailed Description

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This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Conditions

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Pediatric General Anesthesia With Endotracheal Tube

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sealed envelops were used. Ultrasonographers were masked with the group of patients. Participants were masked with the techniques of selecting endotracheal tubes. Care providers and outcome assessors were masked with the techniques of selecting. endotracheal tubes

Study Groups

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Ultrasound

Using ultrasound measurement of the subglottic area to choose endotracheal tube size

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Using ultrasound to determine the size of endotracheal tube

Formula

Using Cole's formula to choose endotracheal tube size

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound

Using ultrasound to determine the size of endotracheal tube

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 1-6 Years
* ASA class 1-2
* Elective Surgery
* GA with oral uncuff endotracheal tube

Exclusion Criteria

* Potential difficult air way from history and physical exam
* Allergy ti ultrasound gel
* neck mass
* unstable vital sign
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Raviwon Atisook

department of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raviwon Atisook

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology siriraj hospital

Locations

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Raviwon Atisook

Bangkok, Bangkoknoi, Thailand

Site Status

Countries

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Thailand

References

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Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.

Reference Type BACKGROUND
PMID: 20808208 (View on PubMed)

Other Identifiers

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RAti-001

Identifier Type: -

Identifier Source: org_study_id

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