NCT03013036

Brief Summary

Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube size by using USG in pediatric patients undergoing elective surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

4.8 years

First QC Date

December 27, 2016

Last Update Submit

January 5, 2017

Conditions

Intubation; Difficult or Failed

Outcome Measures

Primary Outcomes (2)

  • Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance

    three years

  • Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter

    three years

Study Arms (3)

Group I

OTHER

Patients between 1 and 2 years

Device: UltrasonographyDrug: SevofluraneDrug: intravenous midazolamDrug: fentanyl and rocuronium

Group II

OTHER

patients between 3 and 5 years

Device: UltrasonographyDrug: SevofluraneDrug: PropofolDrug: fentanyl and rocuronium

Group III

OTHER

patients between 6 and 8 years

Device: UltrasonographyDrug: SevofluraneDrug: intravenous midazolamDrug: fentanyl and rocuronium

Interventions

UltrasonographyDEVICE
Group IGroup IIGroup III
SevofluraneDRUG
Group IGroup IIGroup III
intravenous midazolamDRUG
Group IGroup III
PropofolDRUG
Group II
fentanyl and rocuroniumDRUG
Group IGroup IIGroup III

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 1 and 8 years
  • Elective surgery

You may not qualify if:

  • Patients with head or neck abnormalities
  • Syndromic patients
  • Emergency surgery and patients with a
  • History of difficult airway
  • Allergy to ultrasound gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Fatih, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

UltrasonographySevofluranePropofolFentanylRocuronium

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Elif A Ozmumcu, M.D.

CONTACT

00905332934202elfaybike@yahoo.com

Fatis Altindas, M.D.

CONTACT

00905337785278fatisaltitas@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 6, 2017

Study Start

February 1, 2013

Primary Completion

December 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

TU(1)