NCT03280498

Brief Summary

In this study the effectiveness of the use of Cole formula and USG were compared in determining the number of the appropriate uncuffed ETT to be used for clinically adequate ventilation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 3, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

August 20, 2017

Last Update Submit

November 17, 2017

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • : The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.

    efficiency of formula

    12 months

Secondary Outcomes (1)

  • To determine the correlation of weight, height and age of child with USG based endotracheal tube size, Cole formula endotracheal tube size and clinically used endotracheal tube size

    12 months

Study Arms (1)

Intubation with Cole formula

OTHER

ASA I-II pediatric patients in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation,

Procedure: Intubation

Interventions

IntubationPROCEDURE

elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted

Intubation with Cole formula

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Children having a diagnosed syndrome, any anomaly of the upper respiratory tract and the head-neck region, recent or active upper respiratory tract infection, previous tracheastomy, requiring nasotracheal entubation, requiring surgery on an emergency basis and being in the ASA III-IV classification -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical Faculty

Istanbul, Cerrahpasa, 34098, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 20, 2017

First Posted

September 12, 2017

Study Start

April 3, 2017

Primary Completion

October 25, 2017

Study Completion

October 31, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)