Pulmonary Disease, Chronic Obstructive Clinical Trial
— H2HOfficial title:
Noninvasive Ventilation for Chronic Obstructive Pulmonary Disease: Hospital to Home Pilot
NCT number | NCT04413643 |
Other study ID # | 18-25750 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2019 |
Est. completion date | April 1, 2024 |
Verified date | April 2024 |
Source | San Francisco Veterans Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: 1. Unplanned readmission rates (all complications) 2. Time to readmissions for admissions other than AECOPD. 3. Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months 4. Pulmonary function (handheld spirometer or in-laboratory based on specific institution resources) at Baseline, 6, and 12 months 5.6 minute walk test at Baseline, 6,and 12 months 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)
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Admission for acute hypercapnic respiratory failure requiring mechanical ventilation or NIV 2. Resolution of acute respiratory failure reflected by normalization of pH and downgrade of clinical status to ward or floor status. 3. Severe COPD defined by GOLD stage 3 (FEV1 30-50%) or 4 (FEV1 < 30%) OR GOLD C or D. Pulmonary function tests (PFTs) done within 3 years preceding admission are acceptable to document an obstructive ventilatory defect and decrease diffusion capacity consistent with emphysema and COPD. If no PFTs are available, bedside spirometry will be performed to confirm COPD. 4. Chronic compensated respiratory acidosis based on PaCO2 >52 adjusted for pH 7.40, on pre-admission laboratory values or after resolution of acute respiratory failure. 5. Able to consent without surrogate and complete all required study visits. Exclusion Criteria: 1. Moderate or severe obstructive sleep apnea (OSA), apnea-hypopnea index (AHI) >15/h. Sleep testing done within the prior 3 years with no increase in body mass index (BMI) >2kg/m2 or major change in cardiopulmonary conditions (new reduced ejection heart failure [HFrEF], atrial fibrillation [AFib], opioid use with morphine dose equivalent (MDDE) >120mg, or cardiothoracic surgery for lung resection or coronary artery bypass grafting) will be accepted for AHI severity. 2. BMI>35 kg/m2 3. Congestive heart failure (HFrEF, EF< 45%) 4. Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis, chest wall restrictive ventilatory defect 5. Lack of stable housing, homelessness, or unreliable electricity source in home environment. 6. Use of NIV at home within past three months 7. Failure to tolerate NIV during initial hospitalization 8. Unable or unwilling to comply with the protocol 9. Age <18 years 10. Inability to consent due to limited cognitive capacity 11. Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco VA Health Care System | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
San Francisco Veterans Affairs Medical Center | ResMed |
United States,
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De Backer L, Vos W, Dieriks B, Daems D, Verhulst S, Vinchurkar S, Ides K, De Backer J, Germonpre P, De Backer W. The effects of long-term noninvasive ventilation in hypercapnic COPD patients: a randomized controlled pilot study. Int J Chron Obstruct Pulmon Dis. 2011;6:615-24. doi: 10.2147/COPD.S22823. Epub 2011 Nov 18. — View Citation
Gunduz C, Basoglu OK, Tasbakan MS. Prevalence of overlap syndrome in chronic obstructive pulmonary disease patients without sleep apnea symptoms. Clin Respir J. 2018 Jan;12(1):105-112. doi: 10.1111/crj.12493. Epub 2016 Jun 6. — View Citation
Mansfield D, Naughton MT. Effects of continuous positive airway pressure on lung function in patients with chronic obstructive pulmonary disease and sleep disordered breathing. Respirology. 1999 Dec;4(4):365-70. doi: 10.1046/j.1440-1843.1999.00206.x. — View Citation
Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451. — View Citation
Oscroft NS, Chadwick R, Davies MG, Quinnell TG, Smith IE. Volume assured versus pressure preset non-invasive ventilation for compensated ventilatory failure in COPD. Respir Med. 2014 Oct;108(10):1508-15. doi: 10.1016/j.rmed.2014.07.010. Epub 2014 Jul 23. — View Citation
Storre JH, Matrosovich E, Ekkernkamp E, Walker DJ, Schmoor C, Dreher M, Windisch W. Home mechanical ventilation for COPD: high-intensity versus target volume noninvasive ventilation. Respir Care. 2014 Sep;59(9):1389-97. doi: 10.4187/respcare.02941. Epub 2014 Jul 29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free survival | Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality | 1 year | |
Secondary | Unplanned readmission rates (all complications) | 1 year | ||
Secondary | Time to readmissions for admissions other than AECOPD | 1 year | ||
Secondary | 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) | 1 year | |
Secondary | 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) | 1 year | |
Secondary | 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) | 1 year | |
Secondary | Spirometry/Lung Function | Forced expiratory volume (FEV1) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Absolute Forced Expiratory Volume (L) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | % Forced Expiratory Volume measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Forced Vital Capacity (FVC) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Absolute Forced Vital Capacity (L) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | % Forced Vital Capacity measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Total Lung Capacity (TLC) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Absolute Total Lung Capacity (L) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | % Total Lung Capacity measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Residual Volume (RV) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Absolute Residual Volume (L) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | % Residual Volume measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | FEV1/FVC% measured at baseline, 6mo and 12mo | 1 year | |
Secondary | Spirometry/Lung Function | Diffusion Capacity (DLCO) measured at baseline, 6mo and 12mo | 1 year | |
Secondary | 6 minute walk test | At baseline, 6 mo and 12 mo | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | Sleep assessed by type 3 portable monitors and transcutaneous capnography | At baseline | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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 | 1 year | |
Secondary | 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). | 1 year |
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