Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation: a randomized, controlled, multi-center study

TY - JOUR

T1 - Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation

T2 - a randomized, controlled, multi-center study

AU - Ankjærgaard, Kasper Linde

AU - Tønnesen, Philip

AU - Laursen, Lars Christian

AU - Hansen, Ejvind Frausing

AU - Andreassen, Helle Frost

AU - Wilcke, Jon Torgny Rostrup

PY - 2016/2/12

Y1 - 2016/2/12

N2 - BACKGROUND: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy.METHODS: Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period. The primary endpoint is time to death or repeat acute hypercapnic respiratory failure; secondary endpoints are one-year mortality, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases.DISCUSSION: Though previous studies of long-term noninvasive ventilation have shown conflicting results, we believe the treatment can reduce mortality and readmissions when applied in patients with previous need of acute ventilatory support, regardless of persistent hypercapnia.TRIAL REGISTRATION: clinicaltrials.org: NCT01513655 16-Jan-2012.

AB - BACKGROUND: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy.METHODS: Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period. The primary endpoint is time to death or repeat acute hypercapnic respiratory failure; secondary endpoints are one-year mortality, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases.DISCUSSION: Though previous studies of long-term noninvasive ventilation have shown conflicting results, we believe the treatment can reduce mortality and readmissions when applied in patients with previous need of acute ventilatory support, regardless of persistent hypercapnia.TRIAL REGISTRATION: clinicaltrials.org: NCT01513655 16-Jan-2012.

KW - Cohort Studies

KW - Home Care Services

KW - Hospitalization

KW - Humans

KW - Hypercapnia

KW - Noninvasive Ventilation

KW - Patient Readmission

KW - Pulmonary Disease, Chronic Obstructive

KW - Respiratory Insufficiency

KW - Retrospective Studies

KW - Survival Rate

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

U2 - 10.1186/s12890-016-0184-6

DO - 10.1186/s12890-016-0184-6

M3 - Journal article

C2 - 26867542

SN - 1471-2466

VL - 16

SP - 1

EP - 5

JO - BMC Pulmonary Medicine

JF - BMC Pulmonary Medicine

M1 - 32

ER -