Prospective Data Collection of Patients < 6 Months of Age... | NCT02033772

Studies
Prospective Data Collection of Patients < 6 Months of Age Undergoing Thoracoscopic Surgery

NCT02033772

Sponsor

Arlyne Thung

Status

Completed

Last Update Posted

Jan 12, 2018Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Congenital Diaphragmatic Hernia
Tracheoesophageal Fistula
Esophageal Atresia

Interventions

Thoracoscopic surgery

Countries

United States

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

Jan 2018

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

Aug 2013

Primary Completion Date

Oct 6, 2017Actual

Completion Date

Oct 6, 2017Actual

First Submitted Date

Nov 22, 2013

First Submission Date that Met QC Criteria

Jan 9, 2014

First Posted Date

Jan 13, 2014Estimated

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

Jan 11, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous CO2 (TC-CO2) and end-tidal CO2 (ET-CO2) during high frequency oscillatory ventilation (HFOV) and thoracoscopic procedures.

Detailed Description

Not provided

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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thoracoscopic surgery		Infants undergoing thoracoscopic surgery.	Procedure: Thoracoscopic surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracoscopic surgery	Procedure		Thoracoscopic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in transcutaneous CO2		Duration of surgery, average of 3 hours.

Secondary Outcomes

Measure	Description	Time Frame
Change in ET-CO2	End-tidal CO2	Duration of surgery, average of 3 hours.
Change in heart rate		Duration of surgery, average of 3 hours.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients presenting for thoracoscopic surgery
Patients aged ≤ 6 months of age

Exclusion Criteria:

Patients presenting for any procedure other than thoracoscopic surgery
Patients aged > 6 months of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Infants < 6 months of age undergoing thoracoscopic surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D065630	Hernias, Diaphragmatic, Congenital
D014138	Tracheoesophageal Fistula
D004933	Esophageal Atresia

Ancestor Terms

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006548	Hernia, Diaphragmatic
D000082122	Internal Hernia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013906	Thoracoscopy

Ancestor Terms

ID	Term
D004724	Endoscopy
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided