Safety and Efficacy of Inhaled Sedation in Management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT07191470 NA COMPLETED

Brief Summary (Plain Language) This study tests whether using a device called AnaConDa® to give a mild gas medicine (isoflurane) helps people with severe flare-ups of chronic obstructive pulmonary disease (COPD) breathe more easily without needing a breathing tube. People with COPD sometimes breathe too fast or not deeply enough during non-invasive ventilation (NIV), which can cause agitation and poor mask fit. We want to see if a light level of isoflurane sedation makes NIV more comfortable, reduces the chance of needing a breathing tube, and is safe to use. Who Can Join Adults aged 18 years or older with a diagnosed COPD flare-up and "hypercapnic respiratory failure" (too much carbon dioxide in the blood) who need NIV are eligible. People with severe liver problems, a history of a rare reaction to anesthesia (malignant hyperthermia), very low consciousness (Glasgow Coma Scale below 12), or certain facial injuries cannot join. Pregnant people and those who recently had airway surgery also cannot join. What Happens During the Study If you agree, we will place a special mask connected to a ventilator and the AnaConDa® device to give isoflurane gas. The gas rate starts at 1.5 mL per hour and aims for a light sedation level where you are drowsy but easily awakened (RASS -1 to -2). We will monitor your heart rate, blood pressure, breathing rate, and oxygen levels every hour for 24 hours. We'll draw small blood samples at the start and again at 2, 6, 12, and 24 hours to check carbon dioxide and oxygen levels. You will be asked how comfortable you feel on a simple scale of 0 ("very uncomfortable") to 10 ("very comfortable") at each time point. Possible Benefits and Risks You may feel more relaxed and better tolerate the breathing mask, which could help you avoid a breathing tube. Risks include too much sedation (making you hard to wake), low blood pressure, slow heart rate, or slowed breathing. If excessive sedation or any serious issue occurs, we will stop the isoflurane and provide immediate medical care. A safety team will review all serious events within 24 hours. Voluntary Participation and Confidentiality Joining this study is your choice. You can stop at any time without affecting your standard medical care. All your data will be kept private and stored in a secure database. Results will be shared only in groups, so no one will know your identity. If you have questions or want to join, please contact: Dr. Dhruva Chaudhry Phone: [phone] Email: [e-mail]

Details

Lead sponsor	Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
Phase	NA
Status	COMPLETED
Enrolment	10
Start date	Sat Apr 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Chronic Obstructive Airway Disease

Interventions

• The Anaesthetic Conserving Device (AnaConDa)

Countries

India