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

NCT07191470 | Completed DMC

• 1 other identifier: BREC/23/121
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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: +91-999-110-1616 Email: dhruvachaudhry@yahoo.co.in

Conditions

Chronic Obstructive Airway Disease

Keywords

COPD; ANACONDA; ISOFLURANE; inhalational anesthesia

Outcome Measures

Primary Outcomes (1)

• Number and percentage of participants with intervention failure

  intervention failure (defined as endotracheal intubation or Richmond Agitation-Sedation Scale score ≤ -3)

  From enrollment to the end of treatment at 7 days

Secondary Outcomes (5)

• Change from baseline in heart rate

  from enrollment to the end of intervention at 7days

• Change from baseline in blood pressure

  From enrollment to the end of intervention at 7 days

• Change in respiratory rate after intervention

  From enrollment to the end of intervention at 7 days

• Change in Richmond Agitation-Sedation Scale (RASS) score

  From enrollment to the end of treatment at 7 days

• Visual Analogue Scale for patient comfort

  From enrollment to the end of intervention at 7 days

Study Arms (1)

Single Arm

EXPERIMENTAL

Isoflurane inhalation via Anaesthetic Conserving Device (AnaConDa)

Device: The Anaesthetic Conserving Device (AnaConDa)

Interventions

The Anaesthetic Conserving Device (AnaConDa) DEVICE

The Anaesthetic Conserving Device (AnaConDa) was developed to facilitate the use of volatile anesthetics like isoflurane and isoflurane in mechanically ventilated patients outside the operating room. The device functions as a passive vaporizer, conserving anesthetic agents and reducing environmental contamination. Studies have demonstrated that AnaConDa-based inhaled sedation offers several advantages over intravenous sedation like better hemodynamic stability, reduced systemic inflammation, and faster recovery times.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. A confirmed diagnosis of COPD who had been admitted to the ICU due to acute exacerbation and hypercapnic respiratory failure requiring non-invasive ventilation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak: lead

Study Sites (1)

Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Aman Ahuja, Assistant Professor, Department of Pulmonary and Critical care medicine

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 24, 2025
• Study Start: April 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)