Chronic Obstructive Airway DiseaseNCT07191470
Safety and Efficacy of Inhaled Sedation in Management of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing The Anaesthetic Conserving Device (AnaConDa) in people with Chronic Obstructive Airway Disease, run by Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- The Anaesthetic Conserving Device (AnaConDa)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences
Rohtak, Haryana, 124001
About this study
Official title: Isoflurane Sedation Using AnaConDa® Device With Non-Invasive Ventilation for the Management of Acute Exacerbation of COPD
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.
Read more
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
Read the 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) can help avoid a breathing tube, but many patients become agitated or uncomfortable with the mask, limiting its success. Traditional sedatives may worsen breathing or build up in the body. Isoflurane is an inhaled anesthetic with bronchodilator properties that can be given in small, quickly adjustable doses using the AnaConDa® device in-line with an NIV circuit. This study will test whether light isoflurane sedation can safely improve NIV tolerance and reduce the need for intubation in COPD flare-ups.
The study investigators will enroll 20 adults (age ≥ 18) admitted with a confirmed COPD exacerbation and hypercapnic respiratory failure who meet medical criteria for BiPAP-mode NIV. After obtaining informed consent, each participant will receive isoflurane delivered at 1.5 mL/hour via a syringe pump connected to the AnaConDa® device placed between the ventilator's Y-piece and the patient's mask. The fresh gas flow will be set equal to each patient's minute ventilation plus 0.5 L/min. NIV settings will be adjusted for comfort and gas exchange: pressure support 8-20 cm H₂O (target 10 mL/kg ideal body weight), PEEP 4-6 cm H₂O, respiratory rate 12-16 breaths/min (I:E ratio 1:3-1:4), and FiO₂ 30-40% to maintain SpO₂ 88-94%.
Sedation will be titrated to a light level (Richmond Agitation Sedation Scale [RASS] -1 to -2). If a patient becomes overly sedated (RASS ≤ -3) or requires endotracheal intubation within 24 hours, this will be recorded as an intervention failure and isoflurane will be stopped immediately. Continuous monitoring will include pulse oximetry, electrocardiogram, and non-invasive blood pressure (every 15 minutes for the first hour, then hourly). Arterial blood gases will be drawn at baseline and at 2, 6, 12, and 24 hours. At each time point we will also record RASS score and ask the patient to rate comfort on a 0-10 visual analogue scale (VAS).
The primary outcome is the proportion of patients experiencing intervention failure (intubation or excessive sedation) within 24 hours. Secondary outcomes are changes over time in vital signs (heart rate, blood pressure, respiratory rate), arterial blood gas values (pH, PaCO₂, PaO₂), sedation depth (RASS), patient comfort (VAS), and safety events (hypotension, bradycardia, respiratory depression, serious adverse events). We will follow participants until hospital discharge or intubation.
An interim analysis after the first 10 patients will assess safety and futility. The trial will be halted early if more than 50% of participants meet failure criteria or if the serious adverse event rate exceeds 20%. Data will be analyzed on both an intent-to-treat and per-protocol basis. Continuous measures will be compared using paired t-tests or nonparametric equivalents; categorical outcomes will use Chi-square or Fisher's exact tests; time-to-intubation will be analyzed with Kaplan-Meier methods.
This study is approved by the Institutional Ethics Committee (BREC 23/121) and will follow ICH-GCP and Declaration of Helsinki guidelines. All participant data will be anonymized and stored in a secure electronic database. Participation is voluntary, and patients may withdraw at any time without affecting their standard medical care.
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- The Anaesthetic Conserving Device (AnaConDa)
- Keywords
- COPD, ANACONDA, ISOFLURANE, inhalational anesthesia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Isoflurane inhalation via Anaesthetic Conserving Device (AnaConDa) Receives: Device: The Anaesthetic Conserving Device (AnaConDa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with intervention failure
intervention failure (defined as endotracheal intubation or Richmond Agitation-Sedation Scale score ≤ -3)
Measured: From enrollment to the end of treatment at 7 days
Secondary outcomes (5)
Change from baseline in heart rate
Absolute difference in heart rate (beats per minute) from the pre-intervention value.
Measured: from enrollment to the end of intervention at 7days
Change from baseline in blood pressure
Absolute difference in systolic arterial pressure (mmHg) and diastolic blood pressure from the pre-intervention value.
Measured: From enrollment to the end of intervention at 7 days
Change in respiratory rate after intervention
Absolute difference in respiratory rate (breaths per minute) from the pre-intervention value.
Measured: From enrollment to the end of intervention at 7 days
Change in Richmond Agitation-Sedation Scale (RASS) score
RASS score (range +4 to -5; lower scores indicate deeper levels of sedation).
Measured: From enrollment to the end of treatment at 7 days
Visual Analogue Scale for patient comfort
Description: VAS score (0 to 10; higher scores indicate greater comfort during NIV).
Measured: From enrollment to the end of intervention at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Apr 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aman Ahuja, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191470
- Sponsor's protocol ID
- BREC/23/121
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isoflurane Sedation Using AnaConDa® Device With Non-Invasive Ventilation for the Management of Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT07191470
- Acronym / sponsor ID
- BREC/23/121
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- COPD, ANACONDA, ISOFLURANE, inhalational anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pandit Bhagwat Dayal Sharma, PGIMS, RohtakUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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) can help avoid a breathing tube, but many patients become agitated or uncomfortable with the mask, limiting its success. Traditional sedatives may worsen breathing or build up in the body. Isoflurane is an inhaled anesthetic with bronchodilator properties that can be given in small, quickly adjustable doses using the AnaConDa® device in-line with an NIV circuit. This study will test whether light isoflurane sedation can safely improve NIV tolerance and reduce the need for intubation in COPD flare-ups.
The study investigators will enroll 20 adults (age ≥ 18) admitted with a confirmed COPD exacerbation and hypercapnic respiratory failure who meet medical criteria for BiPAP-mode NIV. After obtaining informed consent, each participant will receive isoflurane delivered at 1.5 mL/hour via a syringe pump connected to the AnaConDa® device placed between the ventilator's Y-piece and the patient's mask. The fresh gas flow will be set equal to each patient's minute ventilation plus 0.5 L/min. NIV settings will be adjusted for comfort and gas exchange: pressure support 8-20 cm H₂O (target 10 mL/kg ideal body weight), PEEP 4-6 cm H₂O, respiratory rate 12-16 breaths/min (I:E ratio 1:3-1:4), and FiO₂ 30-40% to maintain SpO₂ 88-94%.
Sedation will be titrated to a light level (Richmond Agitation Sedation Scale [RASS] -1 to -2). If a patient becomes overly sedated (RASS ≤ -3) or requires endotracheal intubation within 24 hours, this will be recorded as an intervention failure and isoflurane will be stopped immediately. Continuous monitoring will include pulse oximetry, electrocardiogram, and non-invasive blood pressure (every 15 minutes for the first hour, then hourly). Arterial blood gases will be drawn at baseline and at 2, 6, 12, and 24 hours. At each time point we will also record RASS score and ask the patient to rate comfort on a 0-10 visual analogue scale (VAS).
The primary outcome is the proportion of patients experiencing intervention failure (intubation or excessive sedation) within 24 hours. Secondary outcomes are changes over time in vital signs (heart rate, blood pressure, respiratory rate), arterial blood gas values (pH, PaCO₂, PaO₂), sedation depth (RASS), patient comfort (VAS), and safety events (hypotension, bradycardia, respiratory depression, serious adverse events). We will follow participants until hospital discharge or intubation.
An interim analysis after the first 10 patients will assess safety and futility. The trial will be halted early if more than 50% of participants meet failure criteria or if the serious adverse event rate exceeds 20%. Data will be analyzed on both an intent-to-treat and per-protocol basis. Continuous measures will be compared using paired t-tests or nonparametric equivalents; categorical outcomes will use Chi-square or Fisher's exact tests; time-to-intubation will be analyzed with Kaplan-Meier methods.
This study is approved by the Institutional Ethics Committee (BREC 23/121) and will follow ICH-GCP and Declaration of Helsinki guidelines. All participant data will be anonymized and stored in a secure electronic database. Participation is voluntary, and patients may withdraw at any time without affecting their standard medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: The Anaesthetic Conserving Device (AnaConDa)Isoflurane inhalation via Anaesthetic Conserving Device (AnaConDa) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Anaesthetic Conserving Device (AnaConDa)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. | Device | Single Arm |
Primary outcome
Number and percentage of participants with intervention failure
Time frame: From enrollment to the end of treatment at 7 days
intervention failure (defined as endotracheal intubation or Richmond Agitation-Sedation Scale score ≤ -3)
5 secondary outcomes
Change from baseline in heart rate
Time frame: from enrollment to the end of intervention at 7days
Change from baseline in blood pressure
Time frame: From enrollment to the end of intervention at 7 days
Change in respiratory rate after intervention
Time frame: From enrollment to the end of intervention at 7 days
Change in Richmond Agitation-Sedation Scale (RASS) score
Time frame: From enrollment to the end of treatment at 7 days
Visual Analogue Scale for patient comfort
Time frame: From enrollment to the end of intervention at 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Anaesthetic Conserving Device (AnaConDa) in people with Chronic Obstructive Airway Disease, run by Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with intervention failure (time frame: From enrollment to the end of treatment at 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.