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

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ClinicalTrials.gov Identifier: NCT03647397
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Mercy Health System
Information provided by (Responsible Party):
Molekule

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 Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
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 : August 8, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


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.




Primary Outcome Measures :
  1. Length of stay [ Time Frame: 5 months ]
    Total length of hospital stay for patient


Secondary Outcome Measures :
  1. Readmission rate [ Time Frame: 1 months ]
    Rate of readmission within 30 days of discharge



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647397


Locations
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United States, Illinois
Mercyhealth Hospital - Rockton Avenue
Rockford, Illinois, United States, 61103
Sponsors and Collaborators
Molekule
Mercy Health System
Investigators
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Principal Investigator: Nikhil Rao Molekule
  Study Documents (Full-Text)

Documents provided by Molekule:
Study Protocol  [PDF] October 10, 2018


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Responsible Party: Molekule
ClinicalTrials.gov Identifier: NCT03647397     History of Changes
Other Study ID Numbers: Molekule-08082018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Pneumonia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases