NCT02321956

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

December 17, 2014

Last Update Submit

June 4, 2017

Conditions

Pediatric General Anesthesia With Endotracheal Tube

Keywords

ASA class 1,2age 1-6 yearsGeneral anesthesia with ETT

Outcome Measures

Primary Outcomes (1)

  • Proper size of endotracheal tube

    Clinically fit of endotracheal tube with leak at 20-25 cmH2O

    1 year

Secondary Outcomes (1)

  • Correlation of subglottic diameter and proper size endotracheal tube

    1 year

Study Arms (2)

Ultrasound

EXPERIMENTAL

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

Diagnostic Test: Ultrasound

Formula

NO INTERVENTION

Using Cole's formula to choose endotracheal tube size

Interventions

UltrasoundDIAGNOSTIC_TEST

Using ultrasound to determine the size of endotracheal tube

Ultrasound

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Potential difficult air way from history and physical exam
  • Allergy ti ultrasound gel
  • neck mass
  • unstable vital sign

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raviwon Atisook

Bangkok, Bangkoknoi, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 20808208BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Raviwon Atisook

    Department of anesthesiology siriraj hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of anesthesiology

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 22, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 6, 2017

Record last verified: 2017-06

Locations

TH(1)