Optimization of Bedside Chest X-rays Taken in the Intensi... | NCT05025319

Studies
Optimization of Bedside Chest X-rays Taken in the Intensive Care Unit by Using Current Software-based Techniques

NCT05025319

Sponsor

Joint Authority for Päijät-Häme Social and Health Care

Status

Active, not recruiting

Last Update Posted

Mar 25, 2024Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

X-Rays

Interventions

X-ray image

Countries

Finland

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Aug 26, 2021

First Submission Date that Met QC Criteria

Aug 26, 2021

First Posted Date

Aug 27, 2021Actual

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

Mar 22, 2024

Last Update Posted Date

Mar 25, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marjo Soini, Chief Physicist, Joint Authority for Päijät-Häme Social and Health CarePrincipal Investigator

Lead Sponsor

Joint Authority for Päijät-Häme Social and Health CareOTHER

Collaborators

Name	Class
Tampere University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study investigates how to utilize an algorithm-based virtual grid in lung imaging in intensive care unit patients. The aim is to compare the radiation dose caused by imaging with a virtual grid and a traditional grid and relate this to the achieved image quality. The study aims to determine how the radiation dose can be lowered and still obtain the same diagnostic image quality as using a traditional scatter-limiting lattice.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Taditional Grid		Patients imaged with traditional grid	Radiation: X-ray image
Virtual Grid		Patients imaged with virtual grid	Radiation: X-ray image

Interventions

Name	Type	Description	Arm Group Labels	Other Names
X-ray image	Radiation	Bedside x-ray at intensive unit.	Taditional Grid Virtual Grid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Image quality	Compare the radiation dose caused by imaging with a virtual grid and a traditional grid and relate this to the achieved image qualit	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients in the intensive care unit with an imaging of the lung.

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Intensive care patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joint Authority for Päijät-Häme Social and Health Care		Lahti		15850	Finland

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