An interventional study of Noninvasive Ventilation in Pulmonary Disease, Chronic Obstructive and Noninvasive Ventilation, sponsored by San Francisco Veterans Affairs Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by San Francisco Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment
This is a pilot study to evaluate the impact of providing patients admitted with acute exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to discharge on hospital readmission rates and other secondary outcomes.
Aim 1 To test whether continuation of NIV at home after being initiated during hospitalization for AECOPD improves subsequent admission-free survival in patients with chronic hypercapnic respiratory failure secondary to COPD
Hypothesis 1: The use of targeted NIV during hospitalization with continuation upon discharge to home will improve one-year all-cause mortality as compared to published mortality in the current literature.
Hypothesis 2: The use of targeted NIV during hospitalization with continuation upon discharge to home will reduce readmission rates for AECOPD within-institution historical data.
Aim 2 To evaluate the feasibility of a larger multisite randomized controlled trial in veterans using inclusion and exclusion criteria specified in this pilot.
Outcomes
Primary: Event-free survival (re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality)
Secondary:
6.Health related quality of life (HRQOL) measured by the St. Georges respiratory questionnaires (SGRQ) at Baseline, 1,3,6,9 and 12 months 7.Adherence to NIV at Week 1-2, Months 1,3,6,9 and 12 8.Sleep assessed by type 3 portable monitors 9.Sleep assessed by questionnaires: Insomnia severity index (ISI), Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Short Form (FOSQ-10) at Baseline, 1,3,6,9 and 12 months 11.Utilization of healthcare services (number of visits to outpatient clinics and emergency services, number of inpatient admissions)
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, with the economic and social burden of disease anticipated to increase annually. Acute exacerbations of COPD (AECOPD) are associated with significant in-hospital mortality (6-8%), high readmission rates (60-80%), and even more dramatic 1-year mortality (23-49%).
The use of non-invasive ventilation (NIV) has been extensively evaluated in both patients with stable disease in the home setting and in AECOPD during hospitalization. It is widely accepted that NIV used during AECOPD in the inpatient setting reduces rates of endotracheal intubation, as well as length of ICU and hospital stay. Long-term use of NIV, particularly at higher pressures, in the home setting in COPD patients with evidence of chronic compensated respiratory acidosis (PaCO2 >45mmHg) decreases elevated PaCo2 and serum bicarbonate levels, improves pulmonary function, and improves quality of life. Little is known about whether patients initiated on NIV during an AECOPD and subsequently transitioned to long-term home NIV on discharge demonstrate reduced AECOPD rates, readmission rates, or differences in morbidity and mortality. The few existing randomized trials aimed at this patient population suffer from criticisms of lack of power, varying degrees of patient symptoms, conflicting results, and inconsistent approaches in NIV strategies. Nonetheless, this is an important population to address, as AECOPD frequently leads to accelerated loss of lung function (pre-AECOPD function not recovered), decreased quality of life (QOL), more frequent exacerbations, and higher overall mortality. If NIV can minimize the loss of lung function during the transition period following AECOPD, QOL, physical activity tolerance, readmission rates and overall mortality may improve.
Economic analyses of the use of NIV in patients with AECOPD transitioning from the inpatient to home setting are also sparse, but of high value as healthcare transitions toward bundled payments and penalties for readmissions. This pilot study seeks to better inform the literature on the role of NIV initiated during inpatient AECOPD and continued long-term following discharge home in patients with chronic hypercapnic respiratory failure due to COPD. The investigators hypothesize that the use of NIV during acute inpatient treatment of AECOPD followed by continuation of NIV therapy long-term at home will improve admission free survival, improve quality of life, reduce 1-year exacerbation rates, and reduce 30d readmissions.
This is a prospective 1-year interventional pilot study that will occur at 4 Veterans Affairs (VA) hospitals (Sacramento, Durham, Pittsburgh, and San Francisco).
The total enrollment goal across all sites is 50. Total study period expected includes an enrollment period of approximately 10-12 months and follow-up period of 12 months for a total study duration of approximately 2 years.
Exclusion Criteria:
Subjects will be introduced to NIV and educated on sleep disordered breathing. NIV will be initiated during hospitalization following resolution of acute respiratory failure. NIV settings will be based on inspiratory and expiratory positive airway pressures (IPAP, EPAP), rates, and tidal volumes tolerated during the acute phase of treatment. Initial settings will be set with goals of tolerance and acceptance of therapy. Minimum pressure difference between IPAP and EPAP settings will be 5cmH20. Volume assured pressure support mode with a target tidal volume (Vt) of 8ml/kg ideal body weight will be used. Final device settings and patient parameters will be documented after 10 minutes of acclimation to the device. Data from the device will be reviewed the following day. Tolerance, mask comfort, and acceptance of therapy will be assessed. Changes to settings, mask interface, or other comfort features will be performed at this initial reassessment period.
Device: Noninvasive Ventilation
The use of non-invasive ventilation (NIV) has been extensively evaluated in both patients with stable disease in the home setting and in AECOPD during hospitalization. It is widely accepted that NIV used during AECOPD in the inpatient setting reduces rates of endotracheal intubation, as well as length of ICU and hospital stay. Long-term use of NIV, particularly at higher pressures, in the home setting in COPD patients with evidence of chronic compensated respiratory acidosis (PaCO2 \>45mmHg) decreases elevated PaCo2 and serum bicarbonate levels, improves pulmonary function, and improves quality of life. Little is known about whether patients initiated on NIV during an AECOPD and subsequently transitioned to long-term home NIV on discharge demonstrate reduced AECOPD rates, readmission rates, or differences in morbidity and mortality.
Event-free survival
Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality
Time frame: 1 year
Unplanned readmission rates (all complications)
Time frame: 1 year
Time to readmissions for admissions other than AECOPD
Time frame: 1 year
Change in PaO2 levels from baseline to 12mo
PaO2 will be measured at baseline, 6 and 12 months and evaluated for significant increase (PaO2) or decrease (PaCO2, serum bicarbonate)
Time frame: 1 year
Change PaCO2 levels from baseline to 12mo
PaCO2 will be measured at baseline, 6 and 12 months and evaluated for significant increase (PaO2) or decrease (PaCO2, serum bicarbonate)
Time frame: 1 year
Change in serum bicarbonate levels from baseline to 12mo
Serum bicarbonate will be measured at baseline, 6 and 12 months and evaluated for significant increase (PaO2) or decrease (PaCO2, serum bicarbonate)
Time frame: 1 year
Spirometry/Lung Function
Forced expiratory volume (FEV1) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Absolute Forced Expiratory Volume (L) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
% Forced Expiratory Volume measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Forced Vital Capacity (FVC) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Absolute Forced Vital Capacity (L) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
% Forced Vital Capacity measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Total Lung Capacity (TLC) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Absolute Total Lung Capacity (L) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
% Total Lung Capacity measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Residual Volume (RV) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Absolute Residual Volume (L) measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
% Residual Volume measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
FEV1/FVC% measured at baseline, 6mo and 12mo
Time frame: 1 year
Spirometry/Lung Function
Diffusion Capacity (DLCO) measured at baseline, 6mo and 12mo
Time frame: 1 year
6 minute walk test
At baseline, 6 mo and 12 mo
Time frame: 1 year
St. Georges Respiratory Questionnaire
50-item, 3 component questionnaire. Scores range from 0-100 with a higher score indicating more limitations. Measures the impact of breathing symptoms on quality of life. Administered at baseline, 1, 3, 6, 9 and 12 months
Time frame: 1 year
Adherence/Compliance with NIV
Standard total days used since therapy initiation (day 0). Measured at week 1-2, months 1, 3, 6, 9 and 12. Data will be obtained through remote review of wireless data transmitted from each device.
Time frame: 1 year
Adherence/Compliance with NIV
Percent days with use \>4h/d. Measured at week 1-2, months 1, 3, 6, 9 and 12. Data will be obtained through remote review of wireless data transmitted from each device.
Time frame: 1 year
Adherence/Compliance with NIV
Average time used on days used. Measured at week 1-2, months 1, 3, 6, 9 and 12. Data will be obtained through remote review of wireless data transmitted from each device.
Time frame: 1 year
Adherence/Compliance with NIV
Average time used on all days. Measured at week 1-2, months 1, 3, 6, 9 and 12. Data will be obtained through remote review of wireless data transmitted from each device.
Time frame: 1 year
Sleep assessed by type 3 portable monitors and transcutaneous capnography
At baseline
Time frame: 1 year
Epworth Sleepiness Scale assessment for daytime sleepiness
8 question survey that measures the propensity of falling asleep in different situations. Composite score reported, with a range from 0-24, the higher the score indicating a greater propensity for falling asleep. Administered at baseline, 1, 3, 6, 9 and 12 months
Time frame: 1 year
Insomnia Severity Index assessment for difficulty falling asleep and staying asleep.
7-item survey that uses a likert scale. Measures the nature, severity, and impact of insomnia in adults. Composite score reported (0-28), with a higher score indicating a greater severity of insomnia. Administered at baseline, 1, 3, 6, 9 and 12 months
Time frame: 1 year
Pittsburgh sleep quality index (PSQI) questionnaire to measure sleep disturbance and sleep habits
19 item questionnaire with 7 domains (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), using a likert scale. Measures sleep disturbance and usual sleep habits during the prior month only. A global socre of 0-21 is used, with a score \>5 indicating poor sleep quality. The higher the score the poorer the sleep quality. Administered at baseline, 1, 3, 6, 9 and 12 months
Time frame: 1 year
Functional Outcomes of Sleep Questionnaire (short form) to measure functional status resulting from sleepiness and is a measure of sleep-related HRQoL.
10 item questionnaire with 5 subscales. Subscale scores are averaged to obtain a total score ranging from 5-20, with a higher score indicating better functional status. Administered at baseline, 1, 3, 6, 9 and 12 months
Time frame: 1 year
Utilization of healthcare services (visits to outpatient clinics and emergency services, and number of inpatient admissions)
Visits (both outpatient and inpatient) will be identified based on VA-specific stop codes which define what type of visit occurred (specialty, date, and provider type).
Time frame: 1 year
Plan to share: No
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San Francisco Veterans Affairs Medical Center