- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414891
Non Invasive Ventilation With NAVA vs ASV for AECOPD
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chandigarh, India, 160012
- Respiratory intensive care unit, PGIMER
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NAVA arm
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% |
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).
Other Names:
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Active Comparator: ASV arm
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%.
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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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of NIV failure
Time Frame: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
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NIV failure will be considered in case of • Endotracheal intubation |
From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day mortality rate
Time Frame: 28 days
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28-day mortality including ICU and hospital deaths will be assessed
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28 days
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90-day mortality rate
Time Frame: 90 days
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90-day mortality including deaths after discharge
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90 days
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Time to NIV failure
Time Frame: 28 days
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From initiation of NIV to either intubation or re-initiation of NIV
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28 days
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Time to successful weaning
Time Frame: 28 days
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Time to successful weaning will be defined as the duration between initiation of NIV and successful weaning from NIV
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28 days
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Physician's ease of use of the mode on visual analogue scale
Time Frame: Assessed every 8 hours until primary outcome
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Ease of use will be recorded on a scale of 100 mm, with 0 being very easy and 100 very difficult
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Assessed every 8 hours until primary outcome
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Patient assessed level of comfort using visual analogue scale
Time Frame: 28 days
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Level of comfort will be assessed on a scale of 100 mm, 0 being very comfortable and 100 very uncomfortable
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28 days
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Average number of manipulations
Time Frame: 28 days
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Assessed daily for 5 days or until primary outcome whichever occurs first
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28 days
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Asynchrony index
Time Frame: 28 days
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Assessed daily until primary outcome or 5 day period, whichever occurs first
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28 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Inderpaul Singh Sehgal, MD DM, Postgraduate Institute of Medical Education and Research
Publications and helpful links
General 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.
- Chen 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.
- Tajamul 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.
- Sehgal 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.
- Wang 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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