Efficacy of Nocturnal Nasal Ventilation in Stable, Severe Chronic Obstructive Pulmonary Disease During a 3-Month Controlled Trial

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Objective

To evaluate the efficacy of nocturnal nasal ventilation (NNV) in patients with rigidly defined, severe but stable chronic obstructive pulmonary disease (COPD) and hypercapnia.

Design

By randomization, eligible patients were assigned to an active or a sham treatment arm. Data from these two groups were analyzed statistically.

Material and Methods

Initially, 35 patients with severe COPD (forced expiratory volume in 1 second [FEV1] of less than 40% predicted) and daytime hypercapnia (arterial carbon dioxide tension [Paco2] of more than 45 mm Hg) were enrolled in a 3-month NNV trial. After a minimal observation period of 6 weeks, 13 patients were judged to be clinically stable and were randomized to NNV (N = 7) or sham (N = 6) treatment, consisting of nightly use of a bilevel positive airway pressure (PAP) device set to deliver an inspiratory pressure of either 10 or 0 cm of water (H2O). The device was used in the spontaneous or timed mode and set to a minimal expiratory pressure of 2 cm H2O. Patients underwent extensive physiologic testing including polysomnography and were introduced to the bilevel PAP system during a 2.5-day hospital stay.

Results

The NNV and sham treatment groups were similar in mean age (71.0 versus 66.5 years), Paco2 (54.7 versus 48.5 mm Hg), and FEV1 (0.62 versus 0.72 L). Only four of seven patients in the NNV group were still using the bilevel PAP device at the completion of the trial, as opposed to all six patients in the sham group. Only one patient had a substantial reduction in Paco2—from 50 mm Hg at baseline to 43 mm Hg after 3 months of NNV. He declined further NNV treatment with bilevel PAP. Sham treatment did not lower Paco2. Lung function, nocturnal oxygen saturation, and sleep efficiency remained unchanged in both groups.

Conclusion

Disabled but clinically stable patients with COPD and hypercapnia do not readily accept and are unlikely to benefit from NNV.

Section snippets

Patients And Methods

Study Population.— From our Pulmonary Function Laboratory archival database, we reviewed pulmonary function test results and ABG values from 1989 to 1992 that had been obtained during the patient's routine clinical assessment. After identifying those patients with severe COPD and hypercapnia, we further examined their medical records to find those with the following characteristics: (1) forced expiratory volume in 1 second (FEV1) of less than 40%/% predicted and consistent with severe airway

Results

Patient Contact.—We initially identified 85 patients with severe COPD and hypercapnia from our Pulmonary Function Laboratory database. Twenty-three records were discarded from the mailing because of psychiatric disorders (N = 7), nasal ventilator or continuous PAP use (N = 6), lung transplantation program (N = 4), active cancer (N = 4), and age 80 years or older (N = 2). Of the remaining 62 patients who were contacted by mail, 27 declined the opportunity to participate in the trial or did not

Discussion

The results of this trial suggest that disabled but otherwise stable patients with advanced COPD without evidence of sleep-disordered breathing are unlikely to benefit from NNV. Although these conclusions are based on a small sample size, we are confident about the findings because they conform with the clinical experience at most other medical centers.8,10 Several physiologic principles related to assisted ventilation in patients with severe but stable COPD without further severe nocturnal

Acknowledgment

We thank Lori L. Oeltjenbruns for assistance with preparation of the submitted manuscript.

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    This study was supported in part by Grant MOl RR 00585 from the National Institutes of Health, Public Health Service, and the Mayo Foundation.

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