Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Launched by CENTRAL DENMARK REGION · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of non-invasive ventilation (NIV) for patients experiencing a sudden worsening of chronic obstructive pulmonary disease (COPD), known as an acute exacerbation. The goal is to find out if using NIV before arriving at the hospital, along with standard treatments like inhaled medications and oxygen, can help improve blood acidity levels (pH) in patients with respiratory failure. This trial is particularly focused on patients who may not be able to give consent themselves due to their condition.

To be eligible for this trial, participants must be at least 18 years old, have a history of COPD, and show specific signs of respiratory distress, such as high carbon dioxide levels in their blood or low oxygen levels. Those who qualify will receive NIV along with standard care, while others will receive standard care alone for comparison. This research aims to improve emergency treatment for COPD patients, so it's important to know that participants will be closely monitored by medical professionals throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age greater than or equal to 18 years.
• • 2. Medical history of COPD.
• • 3. Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
• • 4. Respiratory acidosis with a PaCO2 of \> 6,0 kPa and a pH of \< 7,30.
• And one of the following:
• • 5. Respiratory rate of \> 25 per minute.
• • 6. Hypoxia with a PaO2 \< 7 kPa and/or a saturation \< 88% without oxygen administered.
• Exclusion Criteria:
• • 1. Upper gastrointestinal hemorrhage or vomiting.
• • 2. Anatomical abnormality that precludes the use of an oro-nasal interface.
• • 3. Suspicion of pneumothorax.
• • 4. Cardiac or respiratory arrest.
• • 5. Uncontrollable malignant arrhythmia.
• • 6. Refractory shock (systolic blood pressure \< 90 mmHg) despite fluids and/or vasoactive drugs given.
• • 7. Required orotracheal intubation.
• • 8. Suspected upper airway obstruction.
• • 9. No indication for life-prolonging treatment with NIV.