Ignite Creation Date:
2025-12-18 @ 8:44 AM
Ignite Modification Date:
2025-12-23 @ 5:46 PM
Study NCT ID:
NCT03271671
Status:
None
Last Update Posted:
2019-04-10 00:00:00
First Post:
2017-09-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)
Sponsor:
None
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Non-invasive Ventilation (NIV) With Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilator Assist (NAVA) During Acute Respiratory Failure (ARF)
Status:
None
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
NIV is mode of ventilation wherein positive pressure ventilation is delivered by non-invasive interface like nasal mask, face mask, nasal plugs or helmet avoiding invasive interface by endotracheal intubation or by tracheostomy. In 1980s NIV by mask was used with success in patients of obstructive sleep apnea and later on in neuromuscular respiratory failure. Use of NIV has increased subsequently over next 20 years with overall first line NIV being used upto 23% (10) NIV is definitely useful as first line of management in COPD exacerbation, cardiogenic pulmonary edema, post extubation respiratory failure and is also worth trial with conflicting data in cases of acute hypoxemic respiratory failure due to pneumonia, ARDS.
In cases of acute exacerbation of COPD, NIV improves clinical outcomes.(11-13) In a metaanalysis by Ram FS et al which included 14 RCT and 758 patients which showed decreased mortality(11 vs 21%), intubation rate(16 vs 33%) and treatment failure(20 vs 42%)(12). Similarly, there is high quality evidence supporting use in cardiogenic pulmonary edema showing to improve respiratory parameters and decrease intubation rates (14-17). A meta-analysis of 32 studies including 2916 patients in 2013 by Vital FM et al showed that NIV reduces in hospital mortality compared to standard medical care(RR 0.66, 95% CI 0.48 - 0.89)(14) NAVA as mode of ventilation was developed after initial landmark study "neural control of mechanical ventilation in respiratory failure" was published in 1998 by Sinderby(7). It was later on introduced on the servo-i ventilator in 2007. NAVA is a kind of pressure assist ventilation using electrical activity of diaphragm and thus the neural output to initiate the breath, regulate the assist level and cycle off the breath.
In study by Piquilloud et al of 13 patients which compared NAVA with PSV during NIV there was significant difference in asynchronies. Trigger delay (Td) was reduced with NAVA to 35 ms (IQR 31-53 ms) versus 181 ms (122 - 208 ms). Also, there were no premature or delayed cycling, ineffective efforts in the NAVA group. Asynchrony index (AI) with NAVA was 4.9% (2.2 - 10.5%) compared to 15.8% (5.5 - 49.6%) with PSV (20)In a recent meta-analysis comparing PSV with NAVA during NIV by Inderpaul et al which included 9 studies with 96 subjects including both adult and paediatric patients showed that asynchronies were more in PSV than in NAVA in both adult and paediatric studies. The overall pooled mean difference of asynchrony index was 28.02(95% CI, 11.61 - 44.42). also the risk of severe asynchrony was 3.4 % times higher in PSV compared to NAVA group.(9) NAVA mode of ventilation in previous studies has shown to decrease asynchrony with ventilator, mainly reducing ineffective efforts, cycling delays. Ineffective efforts may occur due to presence of intrinsic PEEP which in turn is more common during prolonged insufflations and at high levels of assist. Ineffective efforts may also occur with weak inspiratory efforts which may occur during states of high respiratory drive. NAVA uses electrical activity of diaphragm to trigger a breath and there is marked difference in improving synchrony with studies reporting no wasted efforts when compared to PSV mode. In a study by Vignaux et al showed that during conventional NIV, 40 % of the patients experience asynchrony and the rate of asynchrony correlated with leakage(6). In NAVA mode of ventilation assistance is delivered based upon the neural trigger and hence is not affected by leaks.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
In cases of acute exacerbation of COPD, NIV improves clinical outcomes.(11-13) In a metaanalysis by Ram FS et al which included 14 RCT and 758 patients which showed decreased mortality(11 vs 21%), intubation rate(16 vs 33%) and treatment failure(20 vs 42%)(12). Similarly, there is high quality evidence supporting use in cardiogenic pulmonary edema showing to improve respiratory parameters and decrease intubation rates (14-17). A meta-analysis of 32 studies including 2916 patients in 2013 by Vital FM et al showed that NIV reduces in hospital mortality compared to standard medical care(RR 0.66, 95% CI 0.48 - 0.89)(14) NAVA as mode of ventilation was developed after initial landmark study "neural control of mechanical ventilation in respiratory failure" was published in 1998 by Sinderby(7). It was later on introduced on the servo-i ventilator in 2007. NAVA is a kind of pressure assist ventilation using electrical activity of diaphragm and thus the neural output to initiate the breath, regulate the assist level and cycle off the breath.
In study by Piquilloud et al of 13 patients which compared NAVA with PSV during NIV there was significant difference in asynchronies. Trigger delay (Td) was reduced with NAVA to 35 ms (IQR 31-53 ms) versus 181 ms (122 - 208 ms). Also, there were no premature or delayed cycling, ineffective efforts in the NAVA group. Asynchrony index (AI) with NAVA was 4.9% (2.2 - 10.5%) compared to 15.8% (5.5 - 49.6%) with PSV (20)In a recent meta-analysis comparing PSV with NAVA during NIV by Inderpaul et al which included 9 studies with 96 subjects including both adult and paediatric patients showed that asynchronies were more in PSV than in NAVA in both adult and paediatric studies. The overall pooled mean difference of asynchrony index was 28.02(95% CI, 11.61 - 44.42). also the risk of severe asynchrony was 3.4 % times higher in PSV compared to NAVA group.(9) NAVA mode of ventilation in previous studies has shown to decrease asynchrony with ventilator, mainly reducing ineffective efforts, cycling delays. Ineffective efforts may occur due to presence of intrinsic PEEP which in turn is more common during prolonged insufflations and at high levels of assist. Ineffective efforts may also occur with weak inspiratory efforts which may occur during states of high respiratory drive. NAVA uses electrical activity of diaphragm to trigger a breath and there is marked difference in improving synchrony with studies reporting no wasted efforts when compared to PSV mode. In a study by Vignaux et al showed that during conventional NIV, 40 % of the patients experience asynchrony and the rate of asynchrony correlated with leakage(6). In NAVA mode of ventilation assistance is delivered based upon the neural trigger and hence is not affected by leaks.
In a pooled analysis of studies comparing NAVA with PSV during NIV, it was shown that the use of NAVA significantly improved patient-ventilator synchrony.(9) However, so far, no clinical trial has demonstrated that this improvement in synchrony translates into better clinical outcomes. In this randomized controlled clinical trial, we intend to compare the rates of NIV failure and mortality between NAVA and PSV in subjects with acute respiratory failure managed with NIV.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: