Once Daily Versus Overnight and Symptom Versus Physiological Monitoring to Detect Exacerbations of Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial

Rajeh, Ahmed M Al; Aldabayan, Yousef S; Aldhahir, Abdulelah M.; Pickett, Elisha; Quaderi, Shumonta; Alqahtani, Jaber S; Mandal, Swapna; Lipman, Marc; Hurst, John R.

doi:10.2196/17597

Cited by 20 publications

(32 citation statements)

References 21 publications

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“…It is known that decompensated hypercapnic respiratory failure is associated with increased mortality (34), which is reduced by non-invasive ventilation (NIV) (34,54). While expert societies recommend titrating supplemental oxygen during ECOPD to SaO 2 of 88-92% (7,55), studies of ECOPD suggest the average reduction in SaO 2 was not more than 2% (56,57). Based on this evidence, the panel agreed that when change from baseline is known, a mild ECOPD would be characterized by an arterial oxygen saturation (SaO 2 ) ≥92% and a change ≤3%, a moderate event would be SaO 2 <92% and/or a change >3%, and a severe event by acidotic hypercapnic respiratory failure, i.e., arterial partial pressure of carbon dioxide (PaCO 2 ) >45 mmHg and pH <7.…”

Section: Hypoxemia and Hypercapniamentioning

confidence: 99%

An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal

Celli

Fabbri

Aaron

et al. 2021

Am J Respir Crit Care Med

186

117

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AT A GLANCE COMMENTARYScientific knowledge on the subject: Precise and practical definitions for acute medical events are needed if clinicians are to effectively diagnose and manage patients, provide prognostic information, and implement precision medicine. The current definition of a chronic obstructive pulmonary disease exacerbation (ECOPD) is subjective and based solely on worsening of respiratory symptoms. Further, severity is classified post hoc by the healthcare resource used to treat the event. These shortcomings support the need to revise the ECOPD definition.What this study adds to the field: The Rome proposal for an updated definition of ECOPD addresses many of the shortcomings of older definitions. Based on extensive literature review and using Delphi methodology, it specifies the timespan within which worsening of symptoms define an ECOPD. Second, to the subjective worsening of symptoms it adds a series of clinical variables that are objectively measurable and readily available: dyspnea, oxygen saturation, respiratory rate, heart rate, C-reactive protein and, if needed, arterial blood gases. Third, based on agreed thresholds, it integrates these variables into three mutually exclusive severity categories that can be used to classify the exacerbation severity at initial patient contact. This proposal aims to facilitate and improve clinical care, research, and health services planning.

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Section: Hypoxemia and Hypercapniamentioning

confidence: 99%

An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal

Celli

Fabbri

Aaron

et al. 2021

Am J Respir Crit Care Med

186

117

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“…It has been demonstrated that early detection of exacerbations in Chronic Obstructive Pulmonary Disease (COPD) speeds recovery time [26,27]. Home monitoring has thus been recommended in lung diseases such as COPD to support earlier detection of exacerbation [28,29].…”

Section: Introductionmentioning

confidence: 99%

Home monitoring of physiology and symptoms to detect interstitial lung disease exacerbations and progression: a systematic review

et al. 2021

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BackgroundAcute exacerbations and disease progression in interstitial lung disease (AE-ILD) pose important challenges to clinicians and patients. AE-ILD are variable in presentation but may result in rapid progression of ILD, respiratory failure and death. However, in many cases AE-ILD may go unrecognised so that their true impact and response to therapy is unknown. The potential for home monitoring to facilitate early, and accurate, identification of AE and/or ILD progression has gained interest. With increasing evidence available, there is a need for a systematic review on home monitoring of patients with ILD to summarise the existing data.AimTo systematically evaluate the evidence for use of home monitoring for early detection of exacerbations and/or progression of ILD.MethodWe searched Ovid-EMBASE, MEDLINE, and CINAHL using MeSH terms in accordance with the PRISMA guidelines. PROSPERO registration number (CRD42020215166).ResultsThirteen studies comprising 968 patients have demonstrated that home monitoring is feasible and of potential benefit in patients with ILD. Nine studies reported that mean adherence to home monitoring was greater than 75%, and where spirometry was performed there was a significant correlation (r=0.72–0.98, p<0.001) between home and hospital-based readings. Two studies suggested that home monitoring of Forced Vital Capacity (FVC) might facilitate detection of progression in idiopathic pulmonary fibrosis (IPF).ConclusionDespite the fact that individual studies in this systematic review provide supportive evidence suggesting the feasibility and utility of home monitoring in ILD, further studies are necessary to quantify the potential of home monitoring to detect disease progression and/or acute exacerbations.

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“…The test data have been processed and are ready to feed into the algorithm. Currently, algorithm development is in progress, and we are using analyses from a priori data sets [ 13 ] and results from similar studies to inform the design of our algorithm.…”

Section: Resultsmentioning

confidence: 99%

“…Previous studies [ 12 , 13 ] on exacerbations in COPD found that changes in resting heart rate (RHR), pulse oxygen saturation (SpO 2 ), and peak airflow are highly correlated with symptoms before, during, and after exacerbation onset, as shown in Figure 1 .…”

Section: Introductionmentioning

confidence: 90%

“…Helping patients to detect exacerbations early is therefore important. We have also recently shown that monitoring HR and oxygen saturation via a finger probe may assist in this, especially overnight when the physiological signal is cleaner [ 13 ]. Integration of these signals with additional symptom data and use of innovative data analysis methodology are likely to result in the greatest chance of supporting the early detection of exacerbations and assessment of disease progression.…”

Section: Introductionmentioning

confidence: 99%

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Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH): Protocol for a Prospective Observational Study

Ranjan¹,

Althobiani²,

Jacob³

et al. 2021

JMIR Res Protoc

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Background Chronic lung disorders like chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are characterized by exacerbations. They are unpleasant for patients and sometimes severe enough to cause hospital admission and death. Moreover, due to the COVID-19 pandemic, vulnerable populations with these disorders are at high risk, and their routine care cannot be done properly. Remote monitoring offers a low cost and safe solution for gaining visibility into the health of people in their daily lives, making it useful for vulnerable populations. Objective The primary objective is to assess the feasibility and acceptability of remote monitoring using wearables and mobile phones in patients with pulmonary diseases. The secondary objective is to provide power calculations for future studies centered around understanding the number of exacerbations according to sample size and duration. Methods Twenty participants will be recruited in each of three cohorts (COPD, IPF, and posthospitalization COVID). Data collection will be done remotely using the RADAR-Base (Remote Assessment of Disease And Relapse) mobile health (mHealth) platform for different devices, including Garmin wearable devices and smart spirometers, mobile app questionnaires, surveys, and finger pulse oximeters. Passive data include wearable-derived continuous heart rate, oxygen saturation, respiration rate, activity, and sleep. Active data include disease-specific patient-reported outcome measures, mental health questionnaires, and symptom tracking to track disease trajectory. Analyses will assess the feasibility of lung disorder remote monitoring (including data quality, data completeness, system usability, and system acceptability). We will attempt to explore disease trajectory, patient stratification, and identification of acute clinical events such as exacerbations. A key aspect is understanding the potential of real-time data collection. We will simulate an intervention to acquire responses at the time of the event to assess model performance for exacerbation identification. Results The Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH) study provides a unique opportunity to assess the use of remote monitoring in the evaluation of lung disorders. The study started in the middle of June 2021. The data collection apparatus, questionnaires, and wearable integrations were setup and tested by the clinical teams prior to the start of recruitment. While recruitment is ongoing, real-time exacerbation identification models are currently being constructed. The models will be pretrained daily on data of previous days, but the inference will be run in real time. Conclusions The RALPMH study will provide a reference infrastructure for remote monitoring of lung diseases. It specifically involves information regarding the feasibility and acceptability of remote monitoring and the potential of real-time data collection and analysis in the context of chronic lung disorders. It will help plan and inform decisions in future studies in the area of respiratory health. Trial Registration ISRCTN Registry ISRCTN16275601; https://www.isrctn.com/ISRCTN16275601 International Registered Report Identifier (IRRID) PRR1-10.2196/28873

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Once Daily Versus Overnight and Symptom Versus Physiological Monitoring to Detect Exacerbations of Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial

Cited by 20 publications

References 21 publications

An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal

An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal

Home monitoring of physiology and symptoms to detect interstitial lung disease exacerbations and progression: a systematic review

Remote Assessment of Lung Disease and Impact on Physical and Mental Health (RALPMH): Protocol for a Prospective Observational Study

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