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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03647397
Other study ID # Molekule-08082018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2018
Est. completion date December 31, 2018

Study information

Verified date May 2019
Source Molekule
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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:

1. As evidence to support an installation of PECO in hospital HVAC systems to improve the standard of care for patients with respiratory distress

2. Towards dissemination efforts through publication in a peer-reviewed journal and presentation at national and international conferences

3. For informing healthcare providers and stakeholders

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


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Photo Electrochemical Oxidation (PECO) for Air Purification
PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.

Locations

Country Name City State
United States Mercyhealth Hospital - Rockton Avenue Rockford Illinois

Sponsors (2)

Lead Sponsor Collaborator
Molekule Mercy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of stay Total length of hospital stay for patient 5 months
Secondary Readmission rate Rate of readmission within 30 days of discharge 1 months
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