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

Primary Purpose

Asthma, Pneumonia, Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photo Electrochemical Oxidation (PECO) for Air Purification
Sponsored by
Molekule
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring asthma, environmental intervention, respiratory distress, pediatric hospitalization, pneumonia, bronchiolitis

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercyhealth Hospital - Rockton Avenue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PECO

Arm Description

All pediatric patients admitted for respiratory distress will have the intervention of Photo Electrochemical Oxidation (PECO) for Air Purification.

Outcomes

Primary Outcome Measures

Length of stay
Total length of hospital stay for patient

Secondary Outcome Measures

Readmission rate
Rate of readmission within 30 days of discharge

Full Information

First Posted
August 20, 2018
Last Updated
May 15, 2019
Sponsor
Molekule
Collaborators
Mercy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03647397
Brief Title
PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
Official Title
Use of PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molekule
Collaborators
Mercy Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Pneumonia, Respiratory Distress Syndrome
Keywords
asthma, environmental intervention, respiratory distress, pediatric hospitalization, pneumonia, bronchiolitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PECO
Arm Type
Experimental
Arm Description
All pediatric patients admitted for respiratory distress will have the intervention of Photo Electrochemical Oxidation (PECO) for Air Purification.
Intervention Type
Device
Intervention Name(s)
Photo Electrochemical Oxidation (PECO) for Air Purification
Intervention Description
PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.
Primary Outcome Measure Information:
Title
Length of stay
Description
Total length of hospital stay for patient
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Readmission rate
Description
Rate of readmission within 30 days of discharge
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Rao
Organizational Affiliation
Molekule
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercyhealth Hospital - Rockton Avenue
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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