PECO Air Purification in Hospital Rooms to Improve Health... | NCT03647397

Studies
PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress

NCT03647397

Sponsor

Molekule

Status

Completed

Last Update Posted

May 17, 2019Actual

Enrollment

274Actual

Phase

Not Applicable

Conditions

Asthma
Pneumonia
Respiratory Distress Syndrome

Interventions

Photo Electrochemical Oxidation (PECO) for Air Purification

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

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 8, 2018Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Aug 20, 2018

First Submission Date that Met QC Criteria

Aug 23, 2018

First Posted Date

Aug 27, 2018Actual

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 15, 2019

Last Update Posted Date

May 17, 2019Actual

Name	Class
Mercy Health System	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 study will investigate the efficacy of a novel air purification technology, Photo Electrochemical Oxidation (PECO), has on pediatric patients hospitalized for respiratory distress. The study will take place at Mercyhealth Hospital - Rockton Avenue where all 23 pediatric rooms will be outfitted with portable PECO air purifying units. The main outcomes are the length of stay and progression to ICU, which will be compared with historical controls.

Detailed Description

The goal of this study is to assess whether using PECO to purify air in a hospital can improve health outcomes for pediatric patients with respiratory distress.

The results of this study will be used in three primary ways:

As evidence to support an installation of PECO in hospital HVAC systems to improve the standard of care for patients with respiratory distress
Towards dissemination efforts through publication in a peer-reviewed journal and presentation at national and international conferences
For informing healthcare providers and stakeholders

There are no plans to repeat this study with other hospital partners

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

274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PECO	Experimental	All pediatric patients admitted for respiratory distress will have the intervention of Photo Electrochemical Oxidation (PECO) for Air Purification.	Device: Photo Electrochemical Oxidation (PECO) for Air Purification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photo Electrochemical Oxidation (PECO) for Air Purification	Device	PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay	Total length of hospital stay for patient	5 months

Secondary Outcomes

Measure	Description	Time Frame
Readmission rate	Rate of readmission within 30 days of discharge	1 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: All pediatric patients who are admitted to the Mercyhealth Hospital - Rockton Avenue following the Start Date and have infectious or non-infectious respiratory distress as defined by the following ICD codes will be included in the study:

J00-J06: Acute upper respiratory infections
J09-J18: Influenza and pneumonia
J20-J22: Other acute lower respiratory infections
J30-J39: Other diseases of upper respiratory tract
J40-J47: Chronic lower respiratory diseases
J60-J70: Lung diseases due to external agents
J80-J84: Other respiratory diseases principally affecting the interstitium
J85-J86: Suppurative and necrotic conditions of the lower respiratory tract
J90-J94: Other diseases of the pleura
J95-J95: Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Exclusion Criteria:

Any patient admitted to the NICU
Patients in the ER only
Any patient with non-respiratory conditions
Adults

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikhil Rao	Molekule	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mercyhealth Hospital - Rockton Avenue		Rockford	Illinois	61103	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 10, 2018	May 15, 2019	Prot_003.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D011014	Pneumonia
D012128	Respiratory Distress Syndrome
D004417	Dyspnea
D001988	Bronchiolitis

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided