Induction Hypotension in Pediatric Population | NCT01934062

Studies
Induction Hypotension in Pediatric Population

NCT01934062

Sponsor

Tariq Wani

Status

Completed

Last Update Posted

May 15, 2015Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Pediatric Surgical Patients

Interventions

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

May 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

Aug 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 29, 2013

First Submission Date that Met QC Criteria

Aug 29, 2013

First Posted Date

Sep 4, 2013Estimated

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

May 14, 2015

Last Update Posted Date

May 15, 2015Estimated

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

This is a retrospective chart review to assess the incidence and the degree of blood pressure changes after induction of anesthesia and to study the effect of different induction agents on blood pressure.

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical patients		Pediatric patients having surgery at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013.	Procedure: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013. --------------------------------------------------------------------------------

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypotension	Measure the degree of change from pre-induction levels.	Baseline, 5, 10, & 15 mins. post induction

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between ages of 1 year to 8 years will be included in the study.
Patients with ASA physical classification 1 and 2 will be studied.

Exclusion Criteria:

Patients with any cardiovascular or kidney diseases will be excluded from the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

8 Years

Standard Ages

Child

Study Population

Surgical patients from Nationwide Children's Hosp.

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

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided