published: Oct 29, 2014 | Updated: Oct 30, 2014
AUSTIN, Texas -- Assessment scores for chronic obstructive pulmonary disease (COPD) improved by more than 50% during treatment with a noninvasive open ventilation system (NIOV), results of a small prospective trial showed.
The mean score on the modified British Medical Research Council (mMRC) dyspnea scale decreased by 58% and the mean for the COPD Assessment Test (CAT) by 54%. The decline in scores represented a transition from moderate to severe COPD status before treatment to mild and moderate COPD in the first 12 months after NIOV treatment began.
A COPD patient population like the 21 participants in the NIOV evaluation would have been expected to have deteriorating lung function and health status during follow-up, Brian W. Carlin, MD, of Drexel University School of Medicine in Philadelphia, reported here at CHEST 2014.
"These patients were on maximal medical therapy and were still very symptomatic," Carlin told MedPage Today. "Putting them on the NIOV system improved their dyspnea and substantially improved their COPD assessment scores.
"We think the improvements that we observed have the potential to reduce resource utilization and possibly the cost of care," he added. "As people feel better about themselves and their shortness of breath improves and they have fewer symptoms, they will not be coming back to the doctor's office as much, and they will not be coming into the hospital as much. It's going to be less costly for the healthcare system overall."
The FDA-approved NIOV system increases tidal volume by means of positive pressure ventilation. Reported benefits included reduced dyspnea, increased oxygenation, enhanced exercise endurance, and reduced respiratory muscle activity.
The system was developed as an aid for patients with severe respiratory insufficiency but who can breathe spontaneously and achieve a minimum tidal volume of 3.5 cc/kg of predicted body weight. The system's portability facilitates continuous use during ambulatory activities, physical therapy, occupational therapy, respiratory therapy, and other rehabilitative activities at home or in an institutional setting. Healthcare personnel, patients, and caregivers can learn to operate the NIOV system.
In a recent clinical study, investigators evaluated the wearable 1-lb NIOV system in 15 men with exercise-induced desaturation associated with COPD. Use of the device with compressed oxygen resulted in significantly greater improvement in exercise duration, surface inspiratory muscle electromyography, dyspnea, and oxygenation as compared with unaided exercise, nasal oxygen, and NIOV plus compressed air.
At CHEST 2012, Carlin and colleagues presented results of a study to assess the impact of the NIOV system on activities of daily living (ADL) in 30 patients with COPD. Each patient performed a specified ADL with conventional oxygen therapy. Following a rest period, the patient repeated the ADL with the NIOV system. The results showed significant improvement (P<0.01 to P<0.0001) in scores associated with dyspnea, comfort, and fatigue, and in ADL endurance.
At CHEST 2014, Carlin reported findings from a 24-month study involving 21 patients with various types of chronic respiratory insufficiency: chronic obstructive bronchitis (seven patients), bullous emphysema (five), emphysema and obstructive bronchitis (three), and one case each of bullous emphysema plus alpha-1 antitrypsin deficiency, bronchiolitis obliterans, chronic obstructive bronchitis plus alpha-1 antitrypsin deficiency, pulmonary hypertension, and chronic obstructive bronchitis plus bronchiectasis.
The trial was conducted in two phases: 14.6 months of treatment with standard medications and equipment, followed by a 10.2-month evaluation period with the NIOV system added to existing treatment.
The primary outcome of the single-arm, unblinded study was the change in mean mMRC and CAT scores from the 12 months before NIOV to the treatment period with NIOV.
In the 12 months before NIOV, the 21 patients had a mean mMRC score of 3.38 (score >2 indicates increased dyspnea) and a mean CAT score of 26.71 (score >10 reflects moderate to high impact of respiratory symptoms on health status). The follow-up evaluations during the 12-month period after the addition of NIOV showed mean scores of 1.43 and 12.33 for the mMRC and CAT scores, respectively.
"The significant improvements in clinical measures seen in this study are similar to the results we see in the clinic when patients add a portable noninvasive open ventilation system to an existing regimen, that may included pharmacological agents and oxygen therapy," said Larry C. Casey, MD, PhD, of Mayo Clinic Health System and Franciscan Healthcare in La Crosse, Wis.
"Improvements of this magnitude have rarely occurred over the past several decades, and these findings support the use of a portable noninvasive open ventilation system as part of the treatment paradigm for patients living with chronic lung disease."
In a recent editorial about clinical experience with the NIOV system, Casey said the system "has the potential to reduce hospitalization, ICU days, mechanical ventilation days, resulting in substantial cost savings. My experience with using NIOV is that after a patient uses it once during the initial trial, they want to take it home and they don't want to give it up. With 30 years of academic pulmonary medicine, I've never seen such an immediate and profound impact on a patient's quality of life."
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