Acute Exacerbation of COPDNCT04414891
Non Invasive Ventilation With NAVA vs ASV for AECOPD
A study testing Non invasive ventilation in people with Acute Exacerbation of COPD, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbation of COPD
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2019to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following: (a) an acute (<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation; (b) arterial blood gas analysis showing a PaCO2 >45 mm Hg with either pH between 7.10 and 7.35 or respiratory rate (fR) >30 breaths/minute; and, (c) exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.
Who cannot join
- Patients with any one of the following criteria will be excluded from the current study:
- Non-COPD acute hyper-capneic respiratory failure
- Hypotension (systolic blood pressure <90 mmHg)
- Severe impairment of consciousness (Glasgow coma scale score <8)
- Inability to clear respiratory secretions
- Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality
Show all 13Show fewer
- Subjects who have an artificial airway like tracheostomy tube or T-tube
- Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
- Unwillingness to undergo placement of nasogastric catheter
- Known phrenic nerve lesions
- Suspected diaphragmatic weakness
- Patient already on home NIV therapy for chronic respiratory failure
- Failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Non-invasive Ventilation With Adaptive Support Ventilation Versus Neurally Adjusted Ventilator Assist in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Neurally adjust ventilator assist is a new mode that may improve patient ventilator interactions, improve synchrony and contribute to improved outcomes. Likewise ASV is a mode principled on the closed loop system and is associated with reduction of work associated with breathing and improved outcomes. In this randomised, non-blinded trial, we study these two modes of NIV delivery in patients of AECOPD with hypothesis being that better synchrony with NAVA may translate to better clinical outcomes.
Read the detailed description
Study hypothesis We hypothesize that NIV-NAVA would be superior to ASV in reducing the NIV failure rates in patients with AECOPD. In this study, we plan to compare the ASV with NAVA during NIV in patients with AECOPD.
Methods All consecutive patients meeting the inclusion criteria will be screened and assessed for eligibility. Informed consent will be sought and those enrolled would be randomized to to receive NIV using either the ASV or the NIV-NAVA mode. The NIV will be delivered using a oro-nasal mask with supplemental oxygen as needed.
Delivery of NAVA NAVA will be delivered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
NAVA initiation would involve calibration of the Edi module, placement of the nava catheter nasogastrically, verification of position and selecting appropriate nava level on the basis of required pressure support. In case a favourable response is not obtained, NAVA level will beincreased by 0.2 cm/µV until favourable response is seen (tidal volume 6-8mL/kg, respiratory rate < 25/min)
Delivery of ASV ASV will be delivered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).The patients will be ventilated with an initial setting of 100%-minute volume and will be titrated in increments of 10% as per clinical parameters (respiratory rate, tidal volume).
Monitoring All the patients will be monitored every 15 minutes for respiratory rate, heart rate, blood pressure, Glasgow coma score, pulse oximetry, and signs of respiratory fatigue (paradox), fit of mask and any peri-mask leak. Arterial blood gas analysis will be done at initiation of NIV and then at 1 hour, 4 hours and 24 hours and then at least once a day till primary end point is met.
All the subjects will receive standard of care for acute exacerbation of COPD regardless of their allotted treatment arm.
Randomization Randomization will be done by a computer-generated sequence with blocks of 8 to receive non-invasive ventilation using either the ASV or NAVA. The order of randomisation will be sealed in an opaque envelope, and opened by the physician not directly involved in the study or analysis, at the time of recruitment of patient.
Statistical analysis Results will be presented in a descriptive fashion as mean ± standard deviation (SD), median (interquartile range) or number and percentage. The differences between means of continuous and categorical variables will be analysed using the Student-t-test and chi-square tests, respectively. For data that is not normally distributed the data will be analysed using non-parametric test (Mann-Whitney U).Trends in clinical (respiratory rate and mean arterial blood pressure), arterial blood gas parameters (pH, PaO2, PaCO2) and NIV parameters (peak inspiratory pressure, PEEP, tidal volume) will be analyzed using mixed model technique for repeated measures analysis of variance; the within-groups factor will be time (baseline, one, four and 24 hours), and the between-groups factor will be NIV success. A P value of <0.05 will indicate statistical significance.
- Conditions
- Acute Exacerbation of COPD
- Being tested
- Non invasive ventilation
- Keywords
- AECOPD, NIV, NAVA, ASV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
Also called NIV
Non invasive ventilation will be delivered using an oro-facial interface in both arms. NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).
| Study group | Role | What they receive |
|---|---|---|
| NAVA arm | Experimental | Delivery of NIV-NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
Subjects randomised to this arm will undergo placement of Edi catheter and will be initiated on NIV. Appropriate NAVA level will be selected based on the scalars corresponding to stable ventilation in pressure support mode. During NAVA, the NAVA level would be increased in multiples of 0.2 cm H2O/µV to attain favourable response (tidal volume 6-8mL/kg RR ≤25). Once the patient's clinical condition stabilises, and the Edi maximum starts declining or remains unchanged with stable tidal volumes, NAVA level will be decreased in steps of 0.2 cm H2O/μV every 2 hours. If response to new settings is not favourable earlier settings will be restored. If favourable response is attained the weaning is continued until peak pressure is <12cm H20 and PEEP requirement is <5cm H2O. NIV will be replaced by a venture mask to titrate SpO2 between 88-92% Receives: Device: Non invasive ventilation |
| ASV arm | Active comparator | Patients randomised to the ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland). The patients will be ventilated with an initial setting of 100%-minute volume (MV%). Increments of 10% will be made every 15 minutes to achieve clinical response (relief of dyspnea, RR<30, and tidal volume 6-8mL/kg). The expiratory trigger sensitivity will be set at 35% and adjusted accordingly. PEEP will be commenced at 3-4 cm H2O and increased by 1 cm of H2O to achieve SpO2 between 89-92% and maximum PEEP of 10 cm of H2O. Weaning would be performed by reducing the MV% gradually in decrements of 10%/hour to a MV% of 60% after the peak inspiratory pressure decreases to <8 cm of H2O, and the respiratory rate is < 28 breaths per minute and patient is able to maintain SpO2 > 90% at FiO2< 30%. Once the patient is comfortable on these settings, NIV will be replaced with oxygen supplementation using a venturi mask to maintain SpO2 between 89 and 92%. Receives: Device: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of NIV failure
NIV failure will be considered in case of
- Endotracheal intubation
Measured: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
Secondary outcomes (8)
28-day mortality rate
28-day mortality including ICU and hospital deaths will be assessed
Measured: 28 days
90-day mortality rate
90-day mortality including deaths after discharge
Measured: 90 days
Time to NIV failure
From initiation of NIV to either intubation or re-initiation of NIV
Measured: 28 days
Time to successful weaning
Time to successful weaning will be defined as the duration between initiation of NIV and successful weaning from NIV
Measured: 28 days
Physician's ease of use of the mode on visual analogue scale
Ease of use will be recorded on a scale of 100 mm, with 0 being very easy and 100 very difficult
Measured: Assessed every 8 hours until primary outcome
Patient assessed level of comfort using visual analogue scale
Level of comfort will be assessed on a scale of 100 mm, 0 being very comfortable and 100 very uncomfortable
Measured: 28 days
Average number of manipulations
Assessed daily for 5 days or until primary outcome whichever occurs first
Measured: 28 days
Asynchrony index
Assessed daily until primary outcome or 5 day period, whichever occurs first
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Consecutive patients enrolled would be randomized to either the NAVA arm or ASV arm. NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) ASV NIV ASV will be administered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland)
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inderpaul singh, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Inderpaul Singh Sehgal, MD DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414891
- Sponsor's protocol ID
- NAVA_ASV_AECOPD
- Status last verified
- Aug 2021
- First submitted
- 29 May 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sehgal IS, Kalpakam H, Dhooria S, Aggarwal AN, Prasad KT, Agarwal R. A Randomized Controlled Trial of Noninvasive Ventilation with Pressure Support Ventilation and Adaptive Support Ventilation in Acute Exacerbation of COPD: A Feasibility Study. COPD. 2019 Apr;16(2):168-173. doi: 10.1080/15412555.2019.1620716. Epub 2019 Jun 4.
PubMed 31161812Chen C, Wen T, Liao W. Neurally adjusted ventilatory assist versus pressure support ventilation in patient-ventilator interaction and clinical outcomes: a meta-analysis of clinical trials. Ann Transl Med. 2019 Aug;7(16):382. doi: 10.21037/atm.2019.07.60.
PubMed 31555696Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22.
PubMed 31641071Sehgal IS, Dhooria S, Aggarwal AN, Behera D, Agarwal R. Asynchrony index in pressure support ventilation (PSV) versus neurally adjusted ventilator assist (NAVA) during non-invasive ventilation (NIV) for respiratory failure: systematic review and meta-analysis. Intensive Care Med. 2016 Nov;42(11):1813-1815. doi: 10.1007/s00134-016-4508-z. Epub 2016 Aug 25. No abstract available.
PubMed 27562243Wang DQ, Luo J, Xiong XH, Zhu LH, Zhang WW. [Effect of non-invasive NAVA on the patients with acute exacerbation of chronic obstructive pulmonary disease]. Zhonghua Yi Xue Za Zhi. 2016 Nov 15;96(42):3375-3378. doi: 10.3760/cma.j.issn.0376-2491.2016.42.004. Chinese.
PubMed 27866528Chhabria BA, Prasad KT, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Gandra RR, Sehgal IS. A randomized controlled trial comparing non-invasive ventilation delivered using neurally adjusted ventilator assist (NAVA) or adaptive support ventilation (ASV) in patients with acute exacerbation of chronic obstructive pulmonary disease. J Crit Care. 2023 Jun;75:154250. doi: 10.1016/j.jcrc.2022.154250. Epub 2023 Jan 19.
PubMed 36680884
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Non-invasive Ventilation With Adaptive Support Ventilation Versus Neurally Adjusted Ventilator Assist in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04414891
- Acronym / sponsor ID
- NAVA_ASV_AECOPD
- Conditions
- Acute Exacerbation of COPD
- Keywords
- AECOPD, NIV, NAVA, ASV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Neurally adjust ventilator assist is a new mode that may improve patient ventilator interactions, improve synchrony and contribute to improved outcomes. Likewise ASV is a mode principled on the closed loop system and is associated with reduction of work associated with breathing and improved outcomes. In this randomised, non-blinded trial, we study these two modes of NIV delivery in patients of AECOPD with hypothesis being that better synchrony with NAVA may translate to better clinical outcomes.
Detailed description
Study hypothesis We hypothesize that NIV-NAVA would be superior to ASV in reducing the NIV failure rates in patients with AECOPD. In this study, we plan to compare the ASV with NAVA during NIV in patients with AECOPD.
Methods All consecutive patients meeting the inclusion criteria will be screened and assessed for eligibility. Informed consent will be sought and those enrolled would be randomized to to receive NIV using either the ASV or the NIV-NAVA mode. The NIV will be delivered using a oro-nasal mask with supplemental oxygen as needed.
Delivery of NAVA NAVA will be delivered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
NAVA initiation would involve calibration of the Edi module, placement of the nava catheter nasogastrically, verification of position and selecting appropriate nava level on the basis of required pressure support. In case a favourable response is not obtained, NAVA level will beincreased by 0.2 cm/µV until favourable response is seen (tidal volume 6-8mL/kg, respiratory rate < 25/min)
Delivery of ASV ASV will be delivered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).The patients will be ventilated with an initial setting of 100%-minute volume and will be titrated in increments of 10% as per clinical parameters (respiratory rate, tidal volume).
Monitoring All the patients will be monitored every 15 minutes for respiratory rate, heart rate, blood pressure, Glasgow coma score, pulse oximetry, and signs of respiratory fatigue (paradox), fit of mask and any peri-mask leak. Arterial blood gas analysis will be done at initiation of NIV and then at 1 hour, 4 hours and 24 hours and then at least once a day till primary end point is met.
All the subjects will receive standard of care for acute exacerbation of COPD regardless of their allotted treatment arm.
Randomization Randomization will be done by a computer-generated sequence with blocks of 8 to receive non-invasive ventilation using either the ASV or NAVA. The order of randomisation will be sealed in an opaque envelope, and opened by the physician not directly involved in the study or analysis, at the time of recruitment of patient.
Statistical analysis Results will be presented in a descriptive fashion as mean ± standard deviation (SD), median (interquartile range) or number and percentage. The differences between means of continuous and categorical variables will be analysed using the Student-t-test and chi-square tests, respectively. For data that is not normally distributed the data will be analysed using non-parametric test (Mann-Whitney U).Trends in clinical (respiratory rate and mean arterial blood pressure), arterial blood gas parameters (pH, PaO2, PaCO2) and NIV parameters (peak inspiratory pressure, PEEP, tidal volume) will be analyzed using mixed model technique for repeated measures analysis of variance; the within-groups factor will be time (baseline, one, four and 24 hours), and the between-groups factor will be NIV success. A P value of <0.05 will indicate statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Consecutive patients enrolled would be randomized to either the NAVA arm or ASV arm. NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) ASV NIV ASV will be administered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland)
| Arm | Type | Receives |
|---|---|---|
| NAVA arm | Experimental | Device: Non invasive ventilationDelivery of NIV-NAVA NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks. Subjects randomised to this arm will undergo placement of Edi catheter and will be initiated on NIV. Appropriate NAVA level will be selected based on the scalars corresponding to stable ventilation in pressure support mode. During NAVA, the NAVA level would be increased in multiples of 0.2 cm H2O/µV to attain favourable response (tidal volume 6-8mL/kg RR ≤25). Once the patient's clinical condition stabilises, and the Edi maximum starts declining or remains unchanged with stable tidal volumes, NAVA level will be decreased in steps of 0.2 cm H2O/μV every 2 hours. If response to new settings is not favourable earlier settings will be restored. If favourable response is attained the weaning is continued until peak pressure is <12cm H20 and PEEP requirement is <5cm H2O. NIV will be replaced by a venture mask to titrate SpO2 between 88-92% |
| ASV arm | Active comparator | Device: Non invasive ventilationPatients randomised to the ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland). The patients will be ventilated with an initial setting of 100%-minute volume (MV%). Increments of 10% will be made every 15 minutes to achieve clinical response (relief of dyspnea, RR<30, and tidal volume 6-8mL/kg). The expiratory trigger sensitivity will be set at 35% and adjusted accordingly. PEEP will be commenced at 3-4 cm H2O and increased by 1 cm of H2O to achieve SpO2 between 89-92% and maximum PEEP of 10 cm of H2O. Weaning would be performed by reducing the MV% gradually in decrements of 10%/hour to a MV% of 60% after the peak inspiratory pressure decreases to <8 cm of H2O, and the respiratory rate is < 28 breaths per minute and patient is able to maintain SpO2 > 90% at FiO2< 30%. Once the patient is comfortable on these settings, NIV will be replaced with oxygen supplementation using a venturi mask to maintain SpO2 between 89 and 92%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following: (a) an acute (<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation; (b) arterial blood gas analysis showing a PaCO2 >45 mm Hg with either pH between 7.10 and 7.35 or respiratory rate (fR) >30 breaths/minute; and, (c) exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.
Key exclusion criteria (13 listed)
- Non-COPD acute hyper-capneic respiratory failure
- Hypotension (systolic blood pressure <90 mmHg)
- Severe impairment of consciousness (Glasgow coma scale score <8)
- Inability to clear respiratory secretions
- Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality
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 |
|---|---|---|
| Non invasive ventilationAlso: NIVNon invasive ventilation will be delivered using an oro-facial interface in both arms. NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks. ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland). | Device | ASV arm, NAVA arm |
Primary outcome
Rate of NIV failure
Time frame: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
NIV failure will be considered in case of • Endotracheal intubation
8 secondary outcomes
28-day mortality rate
Time frame: 28 days
90-day mortality rate
Time frame: 90 days
Time to NIV failure
Time frame: 28 days
Time to successful weaning
Time frame: 28 days
Physician's ease of use of the mode on visual analogue scale
Time frame: Assessed every 8 hours until primary outcome
Patient assessed level of comfort using visual analogue scale
Time frame: 28 days
Average number of manipulations
Time frame: 28 days
Asynchrony index
Time frame: 28 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 9 Aug 2021.
- Background: PubMed 31161812Sehgal IS, Kalpakam H, Dhooria S, Aggarwal AN, Prasad KT, Agarwal R. A Randomized Controlled Trial of Noninvasive Ventilation with Pressure Support Ventilation and Adaptive Support Ventilation in Acute Exacerbation of COPD: A Feasibility Study. COPD. 2019 Apr;16(2):168-173. doi: 10.1080/15412555.2019.1620716. Epub 2019 Jun 4.
- Background: PubMed 31555696Chen C, Wen T, Liao W. Neurally adjusted ventilatory assist versus pressure support ventilation in patient-ventilator interaction and clinical outcomes: a meta-analysis of clinical trials. Ann Transl Med. 2019 Aug;7(16):382. doi: 10.21037/atm.2019.07.60.
- Background: PubMed 31641071Tajamul S, Hadda V, Madan K, Tiwari P, Mittal S, Khan MA, Mohan A, Guleria R. Neurally-Adjusted Ventilatory Assist Versus Noninvasive Pressure Support Ventilation in COPD Exacerbation: The NAVA-NICE Trial. Respir Care. 2020 Jan;65(1):53-61. doi: 10.4187/respcare.07122. Epub 2019 Oct 22.
- Background: PubMed 27562243Sehgal IS, Dhooria S, Aggarwal AN, Behera D, Agarwal R. Asynchrony index in pressure support ventilation (PSV) versus neurally adjusted ventilator assist (NAVA) during non-invasive ventilation (NIV) for respiratory failure: systematic review and meta-analysis. Intensive Care Med. 2016 Nov;42(11):1813-1815. doi: 10.1007/s00134-016-4508-z. Epub 2016 Aug 25. No abstract available.
- Background: PubMed 27866528Wang DQ, Luo J, Xiong XH, Zhu LH, Zhang WW. [Effect of non-invasive NAVA on the patients with acute exacerbation of chronic obstructive pulmonary disease]. Zhonghua Yi Xue Za Zhi. 2016 Nov 15;96(42):3375-3378. doi: 10.3760/cma.j.issn.0376-2491.2016.42.004. Chinese.
- Derived from this study: PubMed 36680884Chhabria BA, Prasad KT, Dhooria S, Muthu V, Aggarwal AN, Agarwal R, Gandra RR, Sehgal IS. A randomized controlled trial comparing non-invasive ventilation delivered using neurally adjusted ventilator assist (NAVA) or adaptive support ventilation (ASV) in patients with acute exacerbation of chronic obstructive pulmonary disease. J Crit Care. 2023 Jun;75:154250. doi: 10.1016/j.jcrc.2022.154250. Epub 2023 Jan 19.
- Individual participant dataSharing planned: No
Related trials for Acute Exacerbation of COPD
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation
Not yet recruiting
Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD
COPD, Acute Exacerbation of COPD
Recruiting
Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation
COPD (Chronic Obstructive Pulmonary Disease)
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.
Inderpaul Singh Sehgal, MD DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation in people with Acute Exacerbation of COPD, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 13 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 9 Aug 2021. 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?
Rate of NIV failure (time frame: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414891, which also lists 6 linked publications.
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 9 Aug 2021.