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

• Sponsor: Molekule (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03647397
• Collaborator: Mercy Health System (Other)
• Enrollment: 274
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 57.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma; Pneumonia; Respiratory Distress Syndrome	Device: Photo Electrochemical Oxidation (PECO) for Air Purification	N/A

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:

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Use of PECO Air Purification in Hospital Rooms to Improve Health Outcomes for Pediatric Respiratory Distress
• Actual Study Start Date: Aug 8, 2018
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PECO 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; PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.

Outcome Measures

Primary Outcome Measures

1. Length of stay [5 months]

   Total length of hospital stay for patient

Secondary Outcome Measures

1. Readmission rate [1 months]

   Rate of readmission within 30 days of discharge

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mercyhealth Hospital - Rockton Avenue	Rockford	Illinois	United States	61103

Sponsors and Collaborators

• Molekule
• Mercy Health System

Investigators

• Principal Investigator: Nikhil Rao, Molekule

Study Documents (Full-Text)

• Study Protocol - Oct 10, 2018

More Information

Publications

None provided.

• Responsible Party: Molekule
• ClinicalTrials.gov Identifier: NCT03647397
• Other Study ID Numbers: Molekule-08082018
• First Posted: Aug 27, 2018
• Last Update Posted: May 17, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Molekule: asthma; environmental intervention; respiratory distress; pediatric hospitalization; pneumonia; bronchiolitis
• Additional relevant MeSH terms: Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of May 17, 2019