Respiratory DiseaseNCT04407806
Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness
A study testing Continous Pulse oximeter and Intermittent Pulse oximeter in people with Respiratory Disease and Asthma in Children, run by Corewell Health East at 1 site in United States.
Trial summary
This is a randomized, prospective study to determine if there is a difference in hospital length of stay between patients receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements among pediatric patients admitted for uncomplicated respiratory illness. Read more about this study
- Who is it for?
- Ages 3 months to 14 years
- Conditions the study is for
- Respiratory Disease, Asthma in Children, Pneumonia in Children
- What is being tested?
- Continous Pulse oximeter and Intermittent Pulse oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2020to 2 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission for respiratory illness
- Corrected gestational age greater than 3 months
- Age less than or equal to 14 years old
- Admission to Beaumont children's Hospital Pediatric unit, or transfer to pediatric unit from the Beaumont Children's hospital
Who cannot join
- Primary admission from non-respiratory illness
- Corrected gestational age less than 3 months
- Age greater thn 14 years ld
- History of chronic lung disease and age less than 1 year
- Home oxygen use
- Tracheostomy dependent
- Neuro-muscular disease of hypotonia secondary to chronic/congenital disease
- Cardiac malformation treated with medicatio
Trial locations and contacts
1 site in 1 country.
United States1 site
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
About this study
This is a randomized, prospective study to determine if there is a difference in hospital length of stay between patients receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements among pediatric patients admitted for uncomplicated respiratory illness.
Read the detailed description
Respiratory illnesses are among the most common causes for inpatient pediatric hospitalizations every year. The most common respiratory illnesses that make up these hospitalizations include pneumonia, acute bronchiolitis, and asthma.
Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies depending on the country and age group, but worldwide the annual incidence in children younger than five years of age is 150 million and approximately 2 million pediatric deaths, per year, are attributed to pneumonia. Therefore, it is important to understand this disease and how it impacts pediatric hospital admissions.
Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious etiology such as viruses or bacteria. When an infectious organism is present, the defense mechanisms of the body, including the lungs, are disturbed and the resultant inflammation gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath. Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show elevations in a child's heart rate and decreases in the amount of oxygen present in the blood (pulse oximetry) secondary to the infiltrative processes in the lungs.
Pneumonia is the most common serious infection in the pediatric population and accounts for up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US). Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are admitted to the inpatient pediatric unit for further management. This decision to admit a child to the hospital depends on various underlying factors including age, medical conditions, and severity of illness. One of the factors that is considered when deciding whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of oxygen in the blood.
Bronchiolitis is another common respiratory illness in the pediatric population and is estimated to account for up to 100,000 US hospital admissions annually. There is a seasonality with most infections occurring in the fall and winter months. It is the leading cause of hospitalization in infants and young children with most cases involving children less than two years of age.
Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral infection. When a virus infects the terminal bronchiolar epithelial cells of the lower airways in the lungs, damage to these cells results and subsequently causes cellular sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion, cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased oxygen content in the blood) can occur with acute bronchiolitis with the most severe complication being acute respiratory failure requiring mechanical ventilation.
The third most common respiratory illness that accounts for pediatric hospital admissions is asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is the most common chronic disease in childhood in developed countries and an estimated 8.3% of children in the US had been diagnosed with asthma in 2016.
Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and reversible airway constriction and inflammation. Triggers for asthma exacerbations can include infections, environmental allergens, and other irritants. Smooth muscle constriction in the airways and inflammation/edema result in intermittent and reversible lower airway obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest tightness. Like the other respiratory illnesses mentioned, asthma can also result in hypoxemia.
Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a significant threat to the pediatric population and are major causes of morbidity and mortality throughout the world. In the US, most pediatric hospital admissions are secondary to these illnesses and determining how to best monitor and manage these patients while in the hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one of current debate.
Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first is to have a pediatric patient on continuous monitoring, which involves the child being continuously connected to a monitor that displays various vital signs, one of which being oxygen saturation (SpO2). This technique has been studied over the last several years and many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a patient is continuously connected to a monitor and the monitor alarms an overwhelming amount. One study found that this form of monitoring was used in up to 50% of children in non-ICU settings and that up to 99% of the alarms did not require clinical action. In fact, this study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that greater than 150 alarms can occur on any one patient each day. Furthermore, while these continuous monitors are meant to identify patients who are deteriorating, it has been suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them to improve patient outcomes. Finally, a recent study also demonstrated that the second form of monitoring, scheduled vital checks, may be superior to electronic measurements when assessing patients for deterioration. Currently, there are no guidelines to recommend what form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies evaluating the rationale behind widespread continuous monitoring techniques are lacking.
This study will determine if there is a difference in hospital length of stay between pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements. Patients will be randomized to two groups. One group will be comprised of patients receiving continuous hardwire monitoring during the entire stay in the hospital. The other group will be comprised of patients receiving intermittent vital signs measurements (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four hours, per standard of care on the pediatric unit.
Data will be collected on supplemental oxygen use and patients' level of oxygen saturation throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating of the level of care their child received in hospitalization and parental comfort level with continuing to care for their child at home.
- Being tested
- Continous Pulse oximeter, Intermittent Pulse oximeter
- Keywords
- Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level
- Medical subject headings
- Respiration Disorders, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Pulse oximeterDevice
Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization
Intermittent Pulse oximeterDevice
Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Continuous Pulse Oximetry Monitoring of Oxygen Saturation | Active comparator | Continuous pulse oximetry to measure oxygen saturation Receives: Device: Continous Pulse oximeter |
| Intermittent Pulse Oximetry Monitoring of Oxygen Saturation | Active comparator | Intermittent pulse oximetry to measure oxygen saturation, measured every 4 hours Receives: Device: Intermittent Pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay, Measured in Days
The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.
Measured: Duration of length of stay, up to 14 days
Secondary outcomes (4)
Comfort of Parents: Level of Care Their Child Received in Hospital
Parental rating of care received in hospital, as measured by "Parent Study Questionnaire",using Likert scale, where 5 represents "My child received excellent care" and 1 represents "My child received very poor care". A higher score represents a better outcome.
Measured: On day of hospital discharge, up to 14 days
Comfort of Parents: Continuing to Care for Their Child at Home
Comfort level of parents as measured by "Parent Study Questionnaire", using Likert scale where 5 represents "very comfortable with continuing to care for child at home" and 1 represents "very uncomfortable with continuing care for child at home." A higher score represents a better outcome
Measured: On day of hospital discharge, up to 14 days
Frequency of Nurse Responses to Pulse Oximetry Alarms
Number of times nurses respond to pulse oximetry alarms, tabulated per patient
Measured: Duration of length of stay, up to 14 days
Frequency of Pulse Oximetry Alarms Require Medical Intervention
Number of pulse oximetry alarms requiring intervention by nurses, tabulated per patient
Measured: Duration of length of stay, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start24 Dec 2020
- Primary completion1 May 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective, single-site
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graham Krasan, MD, Corewell Health East
- Investigators
- Graham Krasan, MD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407806
- Sponsor's protocol ID
- 2020-016
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2020
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ernst KD; COMMITTEE ON HOSPITAL CARE. Resources Recommended for the Care of Pediatric Patients in Hospitals. Pediatrics. 2020 Apr;145(4):e20200204. doi: 10.1542/peds.2020-0204. Epub 2020 Mar 23.
PubMed 32205465Barson, W. J., MD. (2019, September 25). Community-acquired pneumonia in children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/community-acquired-pneumonia-in-children-clinical-features-and-diagnosis?search=pneumonia
Jain V, Vashisht R, Yilmaz G, Bhardwaj A. Pneumonia Pathology. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526116/
PubMed 30252372Williams DJ, Zhu Y, Grijalva CG, Self WH, Harrell FE Jr, Reed C, Stockmann C, Arnold SR, Ampofo KK, Anderson EJ, Bramley AM, Wunderink RG, McCullers JA, Pavia AT, Jain S, Edwards KM. Predicting Severe Pneumonia Outcomes in Children. Pediatrics. 2016 Oct;138(4):e20161019. doi: 10.1542/peds.2016-1019.
PubMed 27688362Gereige RS, Laufer PM. Pneumonia. Pediatr Rev. 2013 Oct;34(10):438-56; quiz 455-6. doi: 10.1542/pir.34-10-438. No abstract available.
PubMed 24085792Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.
PubMed 31676530Piedra, P. A., MD, & Stark, A. R., MD. (2020, March 9). Bronchiolitis in infants and children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/bronchiolitis-in-infants-and-children-clinical-features-and-diagnosis?search=bronchiolitis
Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.
PubMed 31676529Sawicki, G., MD, & Haver, K., MD. (2018, November 16). Asthma in children younger than 12 years: Initial evaluation and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/asthma-in-children-younger-than-12-years-initial-evaluation-and-diagnosis?search=asthma
Schondelmeyer AC, Jenkins AM, Allison B, Timmons KM, Loechtenfeldt AM, Pope-Smyth ST, Vaughn LM. Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients. Hosp Pediatr. 2019 Jun;9(6):423-428. doi: 10.1542/hpeds.2019-0007. Epub 2019 May 1.
PubMed 31043435
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Continuous Pulse Oximetry for Pediatric Patients With Stable Respiratory Illness
- ClinicalTrials.gov ID
- NCT04407806
- Acronym / sponsor ID
- 2020-016
- Keywords
- Pulse oximetry, Oxygen saturation, Hypoxia, Blood oxygen level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 10 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, prospective study to determine if there is a difference in hospital length of stay between patients receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements among pediatric patients admitted for uncomplicated respiratory illness.
Detailed description
Respiratory illnesses are among the most common causes for inpatient pediatric hospitalizations every year. The most common respiratory illnesses that make up these hospitalizations include pneumonia, acute bronchiolitis, and asthma.
Pneumonia is one of the top three illnesses requiring pediatric hospitalization and is a significant cause or morbidity and mortality. The incidence of pediatric pneumonia varies depending on the country and age group, but worldwide the annual incidence in children younger than five years of age is 150 million and approximately 2 million pediatric deaths, per year, are attributed to pneumonia. Therefore, it is important to understand this disease and how it impacts pediatric hospital admissions.
Pneumonia is defined as an acute infection of the lung parenchyma secondary to an infectious etiology such as viruses or bacteria. When an infectious organism is present, the defense mechanisms of the body, including the lungs, are disturbed and the resultant inflammation gives rise to parenchymal damage. Symptoms can include fever, cough, and shortness of breath. Findings on imaging can demonstrate infiltrates in the lungs. Vital sign testing can show elevations in a child's heart rate and decreases in the amount of oxygen present in the blood (pulse oximetry) secondary to the infiltrative processes in the lungs.
Pneumonia is the most common serious infection in the pediatric population and accounts for up to 1-4% of all pediatric Emergency Department (ED) visits in the United States (US). Furthermore, of the pediatric patients that present to the ED with pneumonia, 20-25% are admitted to the inpatient pediatric unit for further management. This decision to admit a child to the hospital depends on various underlying factors including age, medical conditions, and severity of illness. One of the factors that is considered when deciding whether to admit a child to the hospital for pneumonia is oxygen saturation, or the amount of oxygen in the blood.
Bronchiolitis is another common respiratory illness in the pediatric population and is estimated to account for up to 100,000 US hospital admissions annually. There is a seasonality with most infections occurring in the fall and winter months. It is the leading cause of hospitalization in infants and young children with most cases involving children less than two years of age.
Acute bronchiolitis refers to lower airway inflammation and obstruction secondary to a viral infection. When a virus infects the terminal bronchiolar epithelial cells of the lower airways in the lungs, damage to these cells results and subsequently causes cellular sloughing and inflammation. This inflammation, coupled with mucous build-up, accounts for the obstruction that is seen in acute bronchiolitis. Symptoms include rhinitis, congestion, cough, tachypnea, wheezing, and accessory muscle use. Like pneumonia, hypoxemia (decreased oxygen content in the blood) can occur with acute bronchiolitis with the most severe complication being acute respiratory failure requiring mechanical ventilation.
The third most common respiratory illness that accounts for pediatric hospital admissions is asthma. Asthma affects 1 in 12 children in the US and is a leading cause of ED visits. It is the most common chronic disease in childhood in developed countries and an estimated 8.3% of children in the US had been diagnosed with asthma in 2016.
Asthma is a complex, multifactorial, immune-mediated disease and is defined by episodic and reversible airway constriction and inflammation. Triggers for asthma exacerbations can include infections, environmental allergens, and other irritants. Smooth muscle constriction in the airways and inflammation/edema result in intermittent and reversible lower airway obstructions. Symptoms of asthma include cough, wheezing, shortness of breath, and chest tightness. Like the other respiratory illnesses mentioned, asthma can also result in hypoxemia.
Respiratory illnesses, including pneumonia, acute bronchiolitis, and pneumonia pose a significant threat to the pediatric population and are major causes of morbidity and mortality throughout the world. In the US, most pediatric hospital admissions are secondary to these illnesses and determining how to best monitor and manage these patients while in the hospital is important. Specifically, the most ideal technique to monitor for hypoxemia is one of current debate.
Currently, there are two main ways to monitor for hypoxemia in a hospital setting. The first is to have a pediatric patient on continuous monitoring, which involves the child being continuously connected to a monitor that displays various vital signs, one of which being oxygen saturation (SpO2). This technique has been studied over the last several years and many concerns have been raised regarding alarm fatigue, or the phenomenon that occurs when a patient is continuously connected to a monitor and the monitor alarms an overwhelming amount. One study found that this form of monitoring was used in up to 50% of children in non-ICU settings and that up to 99% of the alarms did not require clinical action. In fact, this study found that more than 10,000 alarms can occur in a pediatric unit in 1 week and that greater than 150 alarms can occur on any one patient each day. Furthermore, while these continuous monitors are meant to identify patients who are deteriorating, it has been suggested that the efficacy is limited by alarm fatigue and that evidence has not shown them to improve patient outcomes. Finally, a recent study also demonstrated that the second form of monitoring, scheduled vital checks, may be superior to electronic measurements when assessing patients for deterioration. Currently, there are no guidelines to recommend what form of monitoring, continuous monitoring or scheduled vital checks, is superior and studies evaluating the rationale behind widespread continuous monitoring techniques are lacking.
This study will determine if there is a difference in hospital length of stay between pediatric patients admitted for uncomplicated respiratory illnesses receiving continuous hardwire cardiorespiratory monitoring and those receiving intermittent vital signs measurements. Patients will be randomized to two groups. One group will be comprised of patients receiving continuous hardwire monitoring during the entire stay in the hospital. The other group will be comprised of patients receiving intermittent vital signs measurements (heart rate, respiratory rate, blood pressure, oxygen saturation, and temperature) every four hours, per standard of care on the pediatric unit.
Data will be collected on supplemental oxygen use and patients' level of oxygen saturation throughout the hospital stay. On day of hospital discharge, up to 14 days, parents or guardians will be asked to complete the Parent Study Questionnaire, to assess parental rating of the level of care their child received in hospitalization and parental comfort level with continuing to care for their child at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Prospective, single-site
| Arm | Type | Receives |
|---|---|---|
| Continuous Pulse Oximetry Monitoring of Oxygen Saturation | Active comparator | Device: Continous Pulse oximeterContinuous pulse oximetry to measure oxygen saturation |
| Intermittent Pulse Oximetry Monitoring of Oxygen Saturation | Active comparator | Device: Intermittent Pulse oximeterIntermittent pulse oximetry to measure oxygen saturation, measured every 4 hours |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Admission for respiratory illness
- Corrected gestational age greater than 3 months
- Age less than or equal to 14 years old
- Admission to Beaumont children's Hospital Pediatric unit, or transfer to pediatric unit from the Beaumont Children's hospital
Key exclusion criteria (8 listed)
- Primary admission from non-respiratory illness
- Corrected gestational age less than 3 months
- Age greater thn 14 years ld
- History of chronic lung disease and age less than 1 year
- Home oxygen use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous Pulse oximeterPulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization | Device | Continuous Pulse Oximetry Monitoring of Oxygen Saturation |
| Intermittent Pulse oximeterPulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization | Device | Intermittent Pulse Oximetry Monitoring of Oxygen Saturation |
Primary outcome
Length of Stay, Measured in Days
Time frame: Duration of length of stay, up to 14 days
The start time for measurement of the length of stay will be when the order for either vitals checks or hardwire monitoring is entered in the computer. The end time for measurement of length of stay will be when the discharge order is entered into the computer system.
4 secondary outcomes
Comfort of Parents: Level of Care Their Child Received in Hospital
Time frame: On day of hospital discharge, up to 14 days
Comfort of Parents: Continuing to Care for Their Child at Home
Time frame: On day of hospital discharge, up to 14 days
Frequency of Nurse Responses to Pulse Oximetry Alarms
Time frame: Duration of length of stay, up to 14 days
Frequency of Pulse Oximetry Alarms Require Medical Intervention
Time frame: Duration of length of stay, up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32205465Ernst KD; COMMITTEE ON HOSPITAL CARE. Resources Recommended for the Care of Pediatric Patients in Hospitals. Pediatrics. 2020 Apr;145(4):e20200204. doi: 10.1542/peds.2020-0204. Epub 2020 Mar 23.
- BackgroundBarson, W. J., MD. (2019, September 25). Community-acquired pneumonia in children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/community-acquired-pneumonia-in-children-clinical-features-and-diagnosis?search=pneumonia
- Background: PubMed 30252372Jain V, Vashisht R, Yilmaz G, Bhardwaj A. Pneumonia Pathology. 2023 Jul 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK526116/
- Background: PubMed 27688362Williams DJ, Zhu Y, Grijalva CG, Self WH, Harrell FE Jr, Reed C, Stockmann C, Arnold SR, Ampofo KK, Anderson EJ, Bramley AM, Wunderink RG, McCullers JA, Pavia AT, Jain S, Edwards KM. Predicting Severe Pneumonia Outcomes in Children. Pediatrics. 2016 Oct;138(4):e20161019. doi: 10.1542/peds.2016-1019.
- Background: PubMed 24085792Gereige RS, Laufer PM. Pneumonia. Pediatr Rev. 2013 Oct;34(10):438-56; quiz 455-6. doi: 10.1542/pir.34-10-438. No abstract available.
- Background: PubMed 31676530Silver AH, Nazif JM. Bronchiolitis. Pediatr Rev. 2019 Nov;40(11):568-576. doi: 10.1542/pir.2018-0260. No abstract available.
- BackgroundPiedra, P. A., MD, & Stark, A. R., MD. (2020, March 9). Bronchiolitis in infants and children: Clinical features and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/bronchiolitis-in-infants-and-children-clinical-features-and-diagnosis?search=bronchiolitis
- Background: PubMed 31676529Patel SJ, Teach SJ. Asthma. Pediatr Rev. 2019 Nov;40(11):549-567. doi: 10.1542/pir.2018-0282. No abstract available.
- BackgroundSawicki, G., MD, & Haver, K., MD. (2018, November 16). Asthma in children younger than 12 years: Initial evaluation and diagnosis. Retrieved April 13, 2020, from https://www.uptodate.com/contents/asthma-in-children-younger-than-12-years-initial-evaluation-and-diagnosis?search=asthma
- Background: PubMed 31043435Schondelmeyer AC, Jenkins AM, Allison B, Timmons KM, Loechtenfeldt AM, Pope-Smyth ST, Vaughn LM. Factors Influencing Use of Continuous Physiologic Monitors for Hospitalized Pediatric Patients. Hosp Pediatr. 2019 Jun;9(6):423-428. doi: 10.1542/hpeds.2019-0007. Epub 2019 May 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Krasan, MD principal investigator
Beaumont Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous Pulse oximeter and Intermittent Pulse oximeter in people with Respiratory Disease and Asthma in Children, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay, Measured in Days (time frame: Duration of length of stay, up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407806, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.