Use of Mobile Phones for Thermal Imaging of the Chest to... | NCT02381431

Studies
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India

NCT02381431

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jan 16, 2017Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Infections - Bacterial
Pneumonia - Bacterial

Interventions

FLIR ONE

Countries

India

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 2017

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

Mar 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 5, 2015

First Posted Date

Mar 6, 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

Jan 12, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia L. Hibberd, Chief, Division of Global Health, MGHfC, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Lata Medical Research Foundation, Nagpur	OTHER

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 purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.

Detailed Description

Not provided

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

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermal Imaging	Experimental	imaging using a thermal camera	Device: FLIR ONE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FLIR ONE	Device		Thermal Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnosis of bacterial pneumonia	Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present	24 hours

Secondary Outcomes

Measure	Description	Time Frame
diagnosis of additional site of infection possibly related to bacterial pneumonia	Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician	within same hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or younger
patient at DAGA Memorial Hospital, Nagpur, India
had chest x-ray within last 24 hours
consent obtained from one parent
assent obtained if child is 8 years or older

Exclusion Criteria:

thermal image cannot be done within 24 hours of chest x-ray

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia L Hibberd, MD, PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DAGA Memorial Hospital		Nagpur	Maharashtra		India

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections
D018410	Pneumonia, Bacterial
D004194	Disease

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections

Browse Leaves

Not provided

Browse Branches

Not provided