Italian Foundation is undertaking a Rehabilitation With HHFNC in COPD in Nocturnal NIV

Fondazione Don Carlo Gnocchi Onlus is recruiting patients for the clinical trial of Rehabilitation With HHFNC in COPD in Nocturnal NIV.

Humidified High Flow Nasal Cannula (HHFNC), with optional supplemental oxygen delivery, has evolved in recent years with an increasing number of papers that show a better meet with respiratory demand, decrease oxygen dilution, increased Functional Residual Capacity (FRC), dead space washout, more tolerate than Non Invasive Ventilation (NIV) and provide heated and humidified gas. HHFNC is mainly used in intensive care settings or in acute respiratory diseases for the treatment of mild to moderate acute hypoxic respiratory failure and ventilator weaning. The aim of this study is to evaluate, in patients with Chronic Obstructive Pulmonary Disease (COPD) in nocturnal NIV, according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines, whether HHFNC during rehabilitation has an additional effect in increasing the distance in 6 Minute Walking Distance (6MWD) compared to the control group with nocturnal NIV without HHFNC treatment. As secondary objectives, we expect a decrease in Emergency Department (ED) accesses, General Practitioner (GP) unplanned visits, hospitalizations and an improvement of the quality of life and patient satisfaction.

Among the inclusion criteria are:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) <0.7);
  • Nocturnal Non Invasive Ventilation (NIV) prescription according to ATS/ERS guidelines with or without long-term oxygen therapy;
  • Clinical stability (no exacerbation and no changing in respiratory drugs in the last 7 days).

Among primary outcome measures are the Change from baseline in 6MWD and The first outcome we expect to find is a change in the distance at 6-Minute Walking Distance (6MWD).

The study will take place at the IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi, Milan, Italy.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04683952

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