Hemodynamic and Respiratory Effects of Esophageal Dilatio... | NCT02512770

Studies
Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

NCT02512770

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Obstruction of Esophagus
Respiratory Complication
Hemodynamic Instability

Interventions

endoscopic dilatation

Countries

Not provided

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Feb 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 26, 2015

First Submission Date that Met QC Criteria

Jul 30, 2015

First Posted Date

Jul 31, 2015Estimated

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

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

pinar kendigelen, M.D.(Anesthesiology Specialist), Istanbul UniversityPrincipal Investigator

Lead Sponsor

Istanbul UniversityOTHER

Collaborators

Name	Class
Ayse Cigdem Tutuncu	OTHER
Senol Emre	UNKNOWN
Fatis Altindas	UNKNOWN
Kaya, Guner, M.D.

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

Detailed Description

Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dilatation	Experimental	esaphageal dilatation group	Procedure: endoscopic dilatation
control	No Intervention	control group ( only endoscopy for control)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endoscopic dilatation	Procedure		dilatation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
peak inspiratory pressure		at time of endoscopy(0-40minute)

Secondary Outcomes

Measure	Description	Time Frame
complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)		at time of endoscopy and after the endoscopy within 2 hours
Sp02		at time of endoscopy and after the endoscopy within 2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

endoscopy for esaphageal dilatation and control
ASA I-III
0-16 year old

Exclusion Criteria:

ASA IV
endoscopy for removing foreing body

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guner Kaya, Prof.	Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000402	Airway Obstruction

Ancestor Terms

ID	Term
D012131	Respiratory Insufficiency
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided