An interventional study of Non invasive ventilation in Acute Exacerbation of COPD, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Treatment
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.
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.
Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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%
Device: Non invasive ventilation
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%.
Device: Non invasive ventilation
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).
Also known as: NIV
Rate of NIV failure
NIV failure will be considered in case of • Endotracheal intubation
Time frame: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
28-day mortality rate
28-day mortality including ICU and hospital deaths will be assessed
Time frame: 28 days
90-day mortality rate
90-day mortality including deaths after discharge
Time frame: 90 days
Time to NIV failure
From initiation of NIV to either intubation or re-initiation of NIV
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
Average number of manipulations
Assessed daily for 5 days or until primary outcome whichever occurs first
Time frame: 28 days
Asynchrony index
Assessed daily until primary outcome or 5 day period, whichever occurs first
Time frame: 28 days
Plan to share: No
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Post Graduate Institute of Medical Education and Research, Chandigarh