NIV for COPD: Hospital to Home

NCT04413643 | Terminated FDA Device

• 1 other identifier: 18-25750
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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. 1.Unplanned readmission rates (all complications)
2. 2.Time to readmissions for admissions other than AECOPD.
3. 3.Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months
4. 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

Conditions

Pulmonary Disease, Chronic Obstructive; Noninvasive Ventilation

Keywords

COPD; BIPAP; NIV; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality

  1 year

Secondary Outcomes (31)

• Unplanned readmission rates (all complications)

  1 year

• Time to readmissions for admissions other than AECOPD

  1 year

• Change in PaO2 levels from baseline to 12mo

  1 year

• Change PaCO2 levels from baseline to 12mo

  1 year

• Change in serum bicarbonate levels from baseline to 12mo

  1 year

Study Arms (1)

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.

Device: Noninvasive Ventilation

Interventions

Noninvasive Ventilation DEVICE

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.

Noninvasive Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead
• ResMed: collaborator

Study Sites (1)

San Francisco VA Health Care System

San Francisco, California, 94121, United States

Location

Related Publications (7)

• 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.

  PMID: 28528348 BACKGROUND

• Budweiser 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.

  PMID: 17686094 BACKGROUND

• 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.

  PMID: 22135493 BACKGROUND

• 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.

  PMID: 25074944 BACKGROUND

• 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.

  PMID: 25123526 BACKGROUND

• 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.

  PMID: 10612570 BACKGROUND

• 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.

  PMID: 27148977 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Kathleen Sarmiento, MD, MPH

  San Francisco VA Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Medicine Service

Model Details: This is a feasibility trial intended to inform a larger clinical trial based on outcomes data collected.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: June 4, 2020
• Study Start: May 9, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)