Status:
COMPLETED
Safety and Efficacy of Inhaled Sedation in Management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
Conditions:
Chronic Obstructive Airway Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 di...
Detailed Description
Detailed Description: Acute exacerbations of chronic obstructive pulmonary disease (COPD) often lead to too much carbon dioxide in the blood and difficulty breathing. Non-invasive ventilation (NIV) c...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 1\. A confirmed diagnosis of COPD who had been admitted to the ICU due to acute exacerbation and hypercapnic respiratory failure requiring non-invasive ventilation.
- Exclusion Criteria:
- Any known allergy or contraindication to isoflurane, including hypersensitivity to isoflurane or other volatile anaesthetics.
- A history of malignant hyperthermia or hepatic dysfunction suspected to be linked to prior exposure to volatile anaesthetics.
- contraindications for NIV were taken into account, such as severe respiratory failure necessitating immediate invasive mechanical ventilation, facial trauma, burns, or anatomical abnormalities preventing proper mask fit, uncontrolled vomiting or excessive airway secretions, pneumothorax, and neurological impairment with a Glasgow Coma Scale (GCS) score of less than 12 and difficulty in airway protection.
- Patients with hemodynamic instability, including shock unresponsive to fluid resuscitation, severe arrhythmias, or refractory hypotension unmanageable with NIV alone.
- Pregnant patients or individuals who had recently undergone upper airway surgery or tracheostomy.
Exclusion
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07191470
Start Date
April 1 2023
End Date
January 31 2024
Last Update
September 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences
Rohtak, Haryana, India, 124001