Nasal High-Flow in COPD

Launched by MARIEKE DUIVERMAN · Jun 8, 2018

Keywords

ClinConnect Summary

The Nasal High-Flow in COPD clinical trial is studying a new treatment called nasal high-flow therapy (nHFT) for patients experiencing a worsening of their chronic obstructive pulmonary disease (COPD). COPD is a serious lung condition that can lead to frequent hospital visits and a decline in quality of life. This trial aims to find out if using nHFT, which delivers warm, humidified air through a small tube in the nose, can help patients recover better from these worsening episodes.

To participate in this study, individuals must have a diagnosed case of COPD (stages II to IV), have been hospitalized due to a COPD flare-up, and show signs of respiratory failure. They should also have experienced at least two flare-ups in the previous year. During the trial, participants will be randomly assigned to receive either standard care or the nHFT treatment for at least six hours each day while in the hospital and for up to 90 days after discharge. The main goal is to see if nHFT improves patients' health-related quality of life after 90 days. If you or a loved one qualify, this trial could offer a new way to manage COPD exacerbations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients have to fulfil all of the following inclusion criteria:
• • History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking.
• • Being admitted to the hospital with a COPD exacerbation
• • Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34
• • At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
• • Written informed consent is obtained
• Exclusion Criteria:
• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• • No lung function data available
• • The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
• • Inability to comply with the tests
• • The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).