Position of the Endotracheal Tube Cuff in Relation to Cri... | NCT03388710

Studies
Position of the Endotracheal Tube Cuff in Relation to Cricoid in Children.

NCT03388710

Sponsor

King Fahad Medical City

Status

Unknown status

Last Update Posted

Apr 9, 2019Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

D009863

Interventions

XRay

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Jun 30, 2019Estimated

Completion Date

Jun 30, 2019Estimated

First Submitted Date

Dec 25, 2017

First Submission Date that Met QC Criteria

Dec 25, 2017

First Posted Date

Jan 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2019

Last Update Posted Date

Apr 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tariq Wani, Consultant Anesthesiology, King Fahad Medical CityPrincipal Investigator

Lead Sponsor

King Fahad Medical CityOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To verify the exact location of cuff of the endotracheal tube in children.

Detailed Description

The exact location of the cuff of the endotracheal tube in children has not been studied. This study is the first attempt to verify the position of the cuff in the airway with relation to cricoid.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XRay	Radiation	Xray to confirm the location of the endotracheal tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cuff position	Location of the cuff of the ETT	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 1 month to 8 years

Exclusion Criteria:

Any airway pathology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

8 Years

Standard Ages

Child

Study Population

Children for any surgical procedure requiring endotracheal intubation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tariq Wani, MD	Contact	966539417828		tariqwani@gmail.com

Overall Officials

Name	Affiliation	Role
Tariq Wani, MD	Consultant	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Fahad Medical City	Recruiting	Riyadh		11525	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided