Pulmonary Disease, Chronic ObstructiveH2HNCT04413643
NIV for COPD: Hospital to Home
A study testing Noninvasive Ventilation in people with Pulmonary Disease, Chronic Obstructive and Noninvasive Ventilation, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Noninvasive Ventilation
- What is being tested?
- Noninvasive Ventilation
- 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
- 9 May 2019to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission for acute hypercapnic respiratory failure requiring mechanical ventilation or NIV
- Resolution of acute respiratory failure reflected by normalization of pH and downgrade of clinical status to ward or floor status.
- 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.
- 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.
- Able to consent without surrogate and complete all required study visits.
Who cannot join
- 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.
- BMI>35 kg/m2
- Congestive heart failure (HFrEF, EF< 45%)
- Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis, chest wall restrictive ventilatory defect
- Lack of stable housing, homelessness, or unreliable electricity source in home environment.
- Use of NIV at home within past three months
Show all 11Show fewer
- Failure to tolerate NIV during initial hospitalization
- Unable or unwilling to comply with the protocol
- Age <18 years
- Inability to consent due to limited cognitive capacity
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Health Care System
San Francisco, California, 94121
About this study
Official title: Noninvasive Ventilation for Chronic Obstructive Pulmonary Disease: Hospital to Home Pilot
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
Read more
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:
- Unplanned readmission rates (all complications)
- Time to readmissions for admissions other than AECOPD.
- Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months
- 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)
Read the detailed description
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.
- Being tested
- Noninvasive Ventilation
- Keywords
- COPD, BIPAP, NIV, Respiratory failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive VentilationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Ventilation | Experimental | 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. Receives: Device: Noninvasive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality
Measured: 1 year
Secondary outcomes (31)
Unplanned readmission rates (all complications)
Measured: 1 year
Time to readmissions for admissions other than AECOPD
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 year
Spirometry/Lung Function
Forced expiratory volume (FEV1) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Absolute Forced Expiratory Volume (L) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
% Forced Expiratory Volume measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Forced Vital Capacity (FVC) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Absolute Forced Vital Capacity (L) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
% Forced Vital Capacity measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Total Lung Capacity (TLC) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Absolute Total Lung Capacity (L) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
% Total Lung Capacity measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Residual Volume (RV) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Absolute Residual Volume (L) measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
% Residual Volume measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
FEV1/FVC% measured at baseline, 6mo and 12mo
Measured: 1 year
Spirometry/Lung Function
Diffusion Capacity (DLCO) measured at baseline, 6mo and 12mo
Measured: 1 year
6 minute walk test
At baseline, 6 mo and 12 mo
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Sleep assessed by type 3 portable monitors and transcutaneous capnography
At baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start9 May 2019
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility trial intended to inform a larger clinical trial based on outcomes data collected.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- ResMed
- Responsible party
- Principal investigator, Kathleen Sarmiento, San Francisco Veterans Affairs Medical Center
- Investigators
- Kathleen Sarmiento, MD, MPH, Principal investigator, San Francisco VA Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413643
- Sponsor's protocol ID
- 18-25750
- Acronym
- H2H
- Status last verified
- Apr 2024
- First submitted
- 7 Oct 2019
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28528348Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.
PubMed 17686094De 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.
PubMed 22135493Storre 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.
PubMed 25074944Oscroft 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.
PubMed 25123526Mansfield 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.
PubMed 10612570Gunduz 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.
PubMed 27148977
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilation for Chronic Obstructive Pulmonary Disease: Hospital to Home Pilot
- ClinicalTrials.gov ID
- NCT04413643
- Acronym / sponsor ID
- H2H / 18-25750
- Keywords
- COPD, BIPAP, NIV, Respiratory failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- ResMed
- Study start
- 9 May 2019 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
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 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:
- Unplanned readmission rates (all complications)
- Time to readmissions for admissions other than AECOPD.
- Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months
- 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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility trial intended to inform a larger clinical trial based on outcomes data collected.
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Ventilation | Experimental | Device: Noninvasive VentilationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission for acute hypercapnic respiratory failure requiring mechanical ventilation or NIV
- Resolution of acute respiratory failure reflected by normalization of pH and downgrade of clinical status to ward or floor status.
- 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.
- 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.
- Able to consent without surrogate and complete all required study visits.
Key exclusion criteria (11 listed)
- 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.
- BMI>35 kg/m2
- Congestive heart failure (HFrEF, EF< 45%)
- Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis, chest wall restrictive ventilatory defect
- Lack of stable housing, homelessness, or unreliable electricity source in home environment.
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 |
|---|---|---|
| Noninvasive VentilationThe 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. | Device | Noninvasive Ventilation |
Primary outcome
Event-free survival
Time frame: 1 year
Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality
31 secondary outcomes
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
Time frame: 1 year
Change PaCO2 levels from baseline to 12mo
Time frame: 1 year
Change in serum bicarbonate levels from baseline to 12mo
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
Spirometry/Lung Function
Time frame: 1 year
6 minute walk test
Time frame: 1 year
St. Georges Respiratory Questionnaire
Time frame: 1 year
Adherence/Compliance with NIV
Time frame: 1 year
Adherence/Compliance with NIV
Time frame: 1 year
Adherence/Compliance with NIV
Time frame: 1 year
Adherence/Compliance with NIV
Time frame: 1 year
Sleep assessed by type 3 portable monitors and transcutaneous capnography
Time frame: 1 year
Epworth Sleepiness Scale assessment for daytime sleepiness
Time frame: 1 year
Insomnia Severity Index assessment for difficulty falling asleep and staying asleep.
Time frame: 1 year
Pittsburgh sleep quality index (PSQI) questionnaire to measure sleep disturbance and sleep habits
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.
Time frame: 1 year
Utilization of healthcare services (visits to outpatient clinics and emergency services, and number of inpatient admissions)
Time frame: 1 year
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 28528348Murphy 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.
- Background: PubMed 17686094Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.
- Background: PubMed 22135493De 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.
- Background: PubMed 25074944Storre 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.
- Background: PubMed 25123526Oscroft 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.
- Background: PubMed 10612570Mansfield 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.
- Background: PubMed 27148977Gunduz 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.
- 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.
Kathleen Sarmiento, MD, MPH principal investigator
San Francisco VA Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Ventilation in people with Pulmonary Disease, Chronic Obstructive and Noninvasive Ventilation, run by San Francisco Veterans Affairs Medical Center 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 Apr 2024. 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?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
Event-free survival (time frame: 1 year). 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 NCT04413643, which also lists 7 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 25 Apr 2024.