WASHINGTON – The addition of noninvasive ventilation to home oxygen therapy regimens correlated with increased time to readmission or death among patients with exacerbated chronic obstructive pulmonary diseases (COPD), according to a study presented at an international conference of the American Thoracic Society.
Among 116 patients observed with COPD, the 57 patients given home oxygen and noninvasive ventilation reported an average time to readmission of 4.3 months, compared with 1.4 months among the 59 patients given only home oxygen, according to Patrick B. Murphy, PhD, of St. Thomas’ Hospital, London (JAMA. 2017 May 21., who presented this research on the same day it was published in JAMA.
Intervention patients also reported a decrease in annual COPD exacerbations, with an average 3.8 per year compared with 5.1 per year among patients in the control group.In 2013, the reported readmission rate of patients with hypercapnia was one in five, according to Dr. Murphy and his coinvestigators.
Dr. Murphy said the findings are encouraging for patients with COPD suffering from exacerbations from the disease.
“Patients with established chronic respiratory failure secondary to COPD have poor outcomes with limited treatment options available,” the investigators noted. “The results of the current trial are reassuring, suggesting that home noninvasive ventilation added to home oxygen therapy in this population improved the overall clinical outcome without adding to the health burden of the patient.”
In this 12-month, phase III, multicenter, randomized clinical trial, the average age of the patients was 67 years, and the average body mass index was 21.6 mg/k2. The patients had an average partial pressure of carbon dioxide (PaCo2) level of 59, indicating persistent hypercapnia.
The investigators gave those in the intervention group one of three noninvasive home ventilators – nasal, oronasal, or total face mask – to use for a minimum of 6 hours nightly. Patients in both groups received 15 hours of oxygen therapy daily.
Doctors gathered data from patients after 6 weeks, 3 months, 6 months, and 12 months.
After 12 months, risk of readmission or death in the intervention group was 63.4%, while those in the oxygen-only group reported a risk of 80.4%. Despite a 17% risk reduction, a similar number of patients died during the experiment in both groups: five in the noninvasive intervention group and four in the control group, according to the investigators.
At the end of the trial, 16 patients (28%) in the intervention group and 19 (32%) in the control group died.
Dr. Murphy and his peers asserted that these deaths do not take away from the success of the treatment, as the focus of the study was to find a way to reduce readmissions, not necessarily mortality.
“The driver of the clinical improvement in the home oxygen therapy plus home noninvasive ventilation group was readmission avoidance with no significant difference in mortality,” they wrote. “This study has major clinical relevance because readmission avoidance is beneficial to the patient in terms of preservation of lung function and health-related quality of life, as well as providing a direct and indirect cost saving.”
The study was limited by the lack of a double-blind design; however, investigators said that a sham device may have made patients’ respiratory failure worse.
Some patients in the control group were later given ventilation treatment for safety reasons. Eighteen patients were given noninvasive ventilation, although reportedly after the primary endpoint was reached.
Philips Respironics, ResMed, the ResMed Foundation, and the Guy’s and St. Thomas’ Charity funded the study. Dr. Murphy and his coinvestigators reported receiving some manner of financial support from ResMed, Philips Respironics, and B&D Electromedical.