Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160687
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-11-29
Brief Title:
PSV Versus ASV With Intellisync Mode for Delivery of NIV in AECOPD
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Randomised Control Trial to Study the Role of Non-invasive Ventilation Using Pressure Support Ventilation Versus Adaptive Support Ventilation With Intellisync Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2023-12
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:
PAINT-COPD
Brief Summary:
Acute exacerbation of chronic obstructive pulmonary disease COPD is defined acute worsening of respiratory symptoms requiring additional therapy COPD exacerbations affects the health status and quality of life of affected patients The inpatient mortality during exacerbation is 3 to 4 while intensive care unit ICU mortality approaches 43 to 46 Each episode of exacerbation increases the risk of mortality subsequently1 Non-invasive ventilation NIV therapy has established role in mild to moderate exacerbations of COPD But the use of NIV therapy outside of acute exacerbation is uncertain2 NIV use has been shown to prevent endotracheal intubation and improved hospital and ICU survival NIV decreases the work of breathing by unloading the respiratory muscles through assisting the inspiratory phases and counterbalancing the intrinistic positive end expiratory positive pressure ipeep3
NIV is delivered through face mask although newer interfaces like helmet available3 Tradionally pressure targeted mode is used in NIV therapy and is often given intermittently rather than continuously4 NIV therapy via face mask was first used by Meduri et Al in acute respiratory failure patients Subsequent multiple randomized control trials established the role of NIV therapy in better gas exchange reducing PCO2 reducing endotracheal intubation thereby reducing mortality length of stay in hospital3
NIV-PSV pressure support ventilation consists of 2 pressures IPAP inspiratory positive airway pressure and EPAP expiratory positive airway pressure or PEEP Pressure support is usually the pressure added above PEEP Pressure support is usually started with 8-10 cm H2O to obtain a tidal volume of 6-8mlkg ideal body weight EPAPPEEP is adjusted to counterbalance the iPEEP It is usually kept at 4-6cm H2O Fio2 is kept to maintain saturation of 88-92 Inspiratory trigger is usually set at 1 Lmin Expiratory trigger kept at 50 Back up rate should always be kept usually lower than the patient respiratory rate 10-12 breathsmin5
Adaptive support ventilation ASV is a new method of closed loop ventilation which can switch back between pressure support and pressure control modes of ventilation Based on the ideal body weight and of minute volume ventilation given the ASV mode choses the best tidal volume and respiratory rate according to the patient lung mechanics by calculating expiratory time constant RCe through expiratory flow volume curve6 Since closed loop system being a completely automated system prevent frequent adjustment by clinician and thereby increasing the time and capacity of medical staff The first application of such closed loop system in mechanical ventilation was done by saxton in1953 in iron lung for regulation of etCO27 Studies published on ASV as non-invasive mode of ventilation is limited In a feasibility study it has been shown that ASV can be used in non-invasive mode of ventilation with similar results to PSV in COPD patients8
NIV is delivered through face mask although newer interfaces like helmet available3 Tradionally pressure targeted mode is used in NIV therapy and is often given intermittently rather than continuously4 NIV therapy via face mask was first used by Meduri et Al in acute respiratory failure patients Subsequent multiple randomized control trials established the role of NIV therapy in better gas exchange reducing PCO2 reducing endotracheal intubation thereby reducing mortality length of stay in hospital3
NIV-PSV pressure support ventilation consists of 2 pressures IPAP inspiratory positive airway pressure and EPAP expiratory positive airway pressure or PEEP Pressure support is usually the pressure added above PEEP Pressure support is usually started with 8-10 cm H2O to obtain a tidal volume of 6-8mlkg ideal body weight EPAPPEEP is adjusted to counterbalance the iPEEP It is usually kept at 4-6cm H2O Fio2 is kept to maintain saturation of 88-92 Inspiratory trigger is usually set at 1 Lmin Expiratory trigger kept at 50 Back up rate should always be kept usually lower than the patient respiratory rate 10-12 breathsmin5
Adaptive support ventilation ASV is a new method of closed loop ventilation which can switch back between pressure support and pressure control modes of ventilation Based on the ideal body weight and of minute volume ventilation given the ASV mode choses the best tidal volume and respiratory rate according to the patient lung mechanics by calculating expiratory time constant RCe through expiratory flow volume curve6 Since closed loop system being a completely automated system prevent frequent adjustment by clinician and thereby increasing the time and capacity of medical staff The first application of such closed loop system in mechanical ventilation was done by saxton in1953 in iron lung for regulation of etCO27 Studies published on ASV as non-invasive mode of ventilation is limited In a feasibility study it has been shown that ASV can be used in non-invasive mode of ventilation with similar results to PSV in COPD patients8
Detailed Description:
Acute exacerbation of chronic obstructive pulmonary disease are periods of acute worsening during the course of illness which increase hospital admission and mortality Intensive care unit admission and mortality are higher among elderly and those with co-morbidities9
Non-invasive methods of ventilation can be used in mild to moderate exacerbation of COPD They prevent most of the complications of invasive mechanical ventilation and has also reduces mortality in acute exacerbations of COPD In mild to moderate COPD exacerbationspH-725 to 735 non-invasive ventilation NIV failure rate is found to be 15 to 20 In severe COPD exacerbations NIV failure rate approaches upto 52 to 629
Adaptive support ventilation ASV and pressure support ventilation PSV are among the non-invasive modes of ventilation used in COPD exacerbations
Adaptive support ventilation
Adaptive support ventilation is a closed loop ventilation in which it provides both pressure support and pressure controlled ventilation as per the patient needs10 The mode was first described by Hewlett in 1977 in form of mandatory minute ventilation with adaptive pressure control11 Later Dr fleur T Tehrani invented this mode which was later introduced in Galileo ventilator11 This mode supports patient with pressure support when patient has spontaneous breath and when target ventilation is not reached it delivers pressure control breath to achieve adequate ventilation In this mode minute volume is controlled via VtRR combination based on respiratory mechanics of the patient to keep the work of breathing at minimum10 This mode calculates the tidal volume and respiratory rate to be delivered by otis equation in its algorithm after minute volume being set by the clinician to ensure effective ventilation at the alveolar level The inputs provided by the clinician in this mode is minute volume based on ideal body weight ETS flow trigger maximum pressure limit12 The mode after being initiated will deliver a series of 5 pressure limited breaths and deliver a inspiratory pressure15 cm h2o above the baseline pressure during which it calculates dynamic compliance RCe tidal volume and respiratory rate These measurements are used to determine the initial targets of breath rate and tidal volume12 After which based on respiratory rate and effort of the patient inspiratory pressure mandatory breath are adjusted automatically to meet the set minute volume ASV mode can be used as initiation maintenance and weaning phases of mechanical ventilation and it provides full partial or minimal ventilator support during any of these phases12 The number of manual ventilatory adjustments are less compared to conventional mode of ventilation in ASV13 Some randomized controlled trials performed in Non-COPD suggest shorter weaning time with ASV mode of ventilation Shorter weaning is attributed to automated inspiratory pressure change according to patient efforts thereby reducing ventilator patient dysynchrony and frequency of manual manipulation In a randomized control study done by c kirakli et Al found out that in COPD patients ASV mode of ventilation24 hours has shorter weaning duration compared to pressure support mode of ventilation72 hours p-value 0041 But this study has not found any difference in the duration of mechanical ventilation length of stay in ICU weaning failures when ASV and PSV mode were comparedp-value00510 A randomized controlled trial conducted among 80 patients by Bialais et al comparing safety efficacy and workload of intellivent- ASV and conventional mode of ventilation pressure assist mode and pressure support mode found out that tidal volume delivery and spo2 were most of the time in the optimal range 6-10mlkg IBW spo2-92 to 96 for normal lung ARDS and 95-99 for brain injury for intellivent-ASV compared to conventional mode of ventilationp-value-0001 and 0005 However it was found that Pmax maximum inspiratory pressure measured was higher 245 versus 226 with intellivent-ASV mode than conventional ventilationp-value-0042 There was no significant difference between intellivent-ASV and conventional mode of ventilation in terms of time spent in optimal range of parameters like respiratory rate PETCO2 PEEP minute ventilation FIO2 RCexp There was also no difference in length of mechanical ventilation length of ICU stay length of hospital stay ICU mortality hospital mortality and total mortality There was comparative less need for ventilator adjustment with intellivent-ASV mode compared with conventional mode of ventilation14
A randomized control trial by kirakli et Al among 229 patients found out that median mechanical ventilation duration until weaning6743-94 vs 9261-165 p-value-0003 weaning duration22-2 vs 22-80hours p value-0001 and total mechanical ventilation duration 42-6 days vs 4 3-9 days p value-0016 were shorter in ASV group compared to pressure assistcontrol ventilation Also the number of patients succeeding first attempt of extubation was higher in ASV group p value-0001 Weaning success and mortality were comparable between the two groups15
NIV-PSV
Mechanical ventilation in its first form was used at the end of 1930s called tank ventilator Later in 1950s during the polio epidemics modern mechanical ventilators began to emerge Intermittent positive pressure application via anaesthesia mask in treatment of acute respiratory illness was studied in motley and colleagues at Bellevue hospital in 1940s The first application of NIV as CPAP via nasal mask to obstructive sleep apnea patients was done by Sullivan et Al in 1981 Successful application of NIV via full face mask for respiratory failure in COPD patients heart failure patients in 1989 avoided intubation The use of NIV has increased with the introduction of ventilators with effective compensation for air leaks NIV are most commonly used in obstructive sleep apnea COPD and cardiac failure patients and to some extent in failed extubation Although invasive mechanical ventilation has kept the NIV at second place still it is used in above clinical settings16
In a study conducted by Hilbert et Al NIV-PSV was compared with standard medical treatment in COPD patients It was found out that the days of ventilator assistance and length of ICU stay has significantly lower with NIV-PSV treated group 74 days vs 1015 days p001 94 days vs 2112 days p 001 respectively Also NIV support prevented tracheal intubation in acute exacerbation of COPD patients significantly 26 vs 71 compared to standard medical therapy17
Randomized control study conducted by laurent etal suggested that non-invasive ventilation compared to standard medical treatment for COPD exacerbation could reduce the intubation rates length of stay in hospital18 Another study by plant et Al replicated the same results that early NIV therapy would reduce the number of intubation needed in mild to moderate exacerbation of COPD patients and improvement in paco2 and respiratory rate This study suggested that NIV therapy can be effectively administered in general respiratory wards also19
NIV therapy was used in hypoxemic respiratory failure in post-abdominal surgery patients compared with oxygen therapy alone by jaber et Al NIV therapy has significantly reduced tracheal reintubation rates within 7 days following surgery 331 vs 455 p value - 003 and also it provided more invasive ventilation free days compared with standard oxygen therapy254 vs 232 days Gas exchange was found to be similar with NIV and standard oxygen therapy in hypoxemic respiratory failure in this study Also the NIV group had fewer pulmonary infections compared with oxygen therapy group20
A randomized study by Nava et Al conducted to study the effectiveness of NIV to prevent reintubation suggested that early institution of NIV after extubation especially in high risk patients ie COPD Cardiac failure hypercapneic patients may prevent reintubation rates448 vs 1249 p-value-0027 The delayed delivery of NIV after extubation can cause increase in mortality So timely delivery of NIV support can reduce mortality upto 60 In this study NIV support was given atleast 8 hoursday after extubation21
Patient-ventilator asynchrony is well known in patients who are mechanically ventilated Although there are no studies that suggest direct patient related outcome due to asynchrony it is well known patient-ventilator asynchrony prolong the duration of mechanical ventilation22 Although correlation with oesophageal pressure is the standard way of detecting the patient-ventilator asynchrony a trained eye can detect most of the asynchronies using pressure-time or flow-time waveform analysis23Multiple studies has suggested better patient-ventilator interactions with adaptive support mode of ventilation requiring less manipulations from the clinician and also facilitating early liberation from mechanical ventilation compared to other modes of ventilation24-26
Non-invasive methods of ventilation can be used in mild to moderate exacerbation of COPD They prevent most of the complications of invasive mechanical ventilation and has also reduces mortality in acute exacerbations of COPD In mild to moderate COPD exacerbationspH-725 to 735 non-invasive ventilation NIV failure rate is found to be 15 to 20 In severe COPD exacerbations NIV failure rate approaches upto 52 to 629
Adaptive support ventilation ASV and pressure support ventilation PSV are among the non-invasive modes of ventilation used in COPD exacerbations
Adaptive support ventilation
Adaptive support ventilation is a closed loop ventilation in which it provides both pressure support and pressure controlled ventilation as per the patient needs10 The mode was first described by Hewlett in 1977 in form of mandatory minute ventilation with adaptive pressure control11 Later Dr fleur T Tehrani invented this mode which was later introduced in Galileo ventilator11 This mode supports patient with pressure support when patient has spontaneous breath and when target ventilation is not reached it delivers pressure control breath to achieve adequate ventilation In this mode minute volume is controlled via VtRR combination based on respiratory mechanics of the patient to keep the work of breathing at minimum10 This mode calculates the tidal volume and respiratory rate to be delivered by otis equation in its algorithm after minute volume being set by the clinician to ensure effective ventilation at the alveolar level The inputs provided by the clinician in this mode is minute volume based on ideal body weight ETS flow trigger maximum pressure limit12 The mode after being initiated will deliver a series of 5 pressure limited breaths and deliver a inspiratory pressure15 cm h2o above the baseline pressure during which it calculates dynamic compliance RCe tidal volume and respiratory rate These measurements are used to determine the initial targets of breath rate and tidal volume12 After which based on respiratory rate and effort of the patient inspiratory pressure mandatory breath are adjusted automatically to meet the set minute volume ASV mode can be used as initiation maintenance and weaning phases of mechanical ventilation and it provides full partial or minimal ventilator support during any of these phases12 The number of manual ventilatory adjustments are less compared to conventional mode of ventilation in ASV13 Some randomized controlled trials performed in Non-COPD suggest shorter weaning time with ASV mode of ventilation Shorter weaning is attributed to automated inspiratory pressure change according to patient efforts thereby reducing ventilator patient dysynchrony and frequency of manual manipulation In a randomized control study done by c kirakli et Al found out that in COPD patients ASV mode of ventilation24 hours has shorter weaning duration compared to pressure support mode of ventilation72 hours p-value 0041 But this study has not found any difference in the duration of mechanical ventilation length of stay in ICU weaning failures when ASV and PSV mode were comparedp-value00510 A randomized controlled trial conducted among 80 patients by Bialais et al comparing safety efficacy and workload of intellivent- ASV and conventional mode of ventilation pressure assist mode and pressure support mode found out that tidal volume delivery and spo2 were most of the time in the optimal range 6-10mlkg IBW spo2-92 to 96 for normal lung ARDS and 95-99 for brain injury for intellivent-ASV compared to conventional mode of ventilationp-value-0001 and 0005 However it was found that Pmax maximum inspiratory pressure measured was higher 245 versus 226 with intellivent-ASV mode than conventional ventilationp-value-0042 There was no significant difference between intellivent-ASV and conventional mode of ventilation in terms of time spent in optimal range of parameters like respiratory rate PETCO2 PEEP minute ventilation FIO2 RCexp There was also no difference in length of mechanical ventilation length of ICU stay length of hospital stay ICU mortality hospital mortality and total mortality There was comparative less need for ventilator adjustment with intellivent-ASV mode compared with conventional mode of ventilation14
A randomized control trial by kirakli et Al among 229 patients found out that median mechanical ventilation duration until weaning6743-94 vs 9261-165 p-value-0003 weaning duration22-2 vs 22-80hours p value-0001 and total mechanical ventilation duration 42-6 days vs 4 3-9 days p value-0016 were shorter in ASV group compared to pressure assistcontrol ventilation Also the number of patients succeeding first attempt of extubation was higher in ASV group p value-0001 Weaning success and mortality were comparable between the two groups15
NIV-PSV
Mechanical ventilation in its first form was used at the end of 1930s called tank ventilator Later in 1950s during the polio epidemics modern mechanical ventilators began to emerge Intermittent positive pressure application via anaesthesia mask in treatment of acute respiratory illness was studied in motley and colleagues at Bellevue hospital in 1940s The first application of NIV as CPAP via nasal mask to obstructive sleep apnea patients was done by Sullivan et Al in 1981 Successful application of NIV via full face mask for respiratory failure in COPD patients heart failure patients in 1989 avoided intubation The use of NIV has increased with the introduction of ventilators with effective compensation for air leaks NIV are most commonly used in obstructive sleep apnea COPD and cardiac failure patients and to some extent in failed extubation Although invasive mechanical ventilation has kept the NIV at second place still it is used in above clinical settings16
In a study conducted by Hilbert et Al NIV-PSV was compared with standard medical treatment in COPD patients It was found out that the days of ventilator assistance and length of ICU stay has significantly lower with NIV-PSV treated group 74 days vs 1015 days p001 94 days vs 2112 days p 001 respectively Also NIV support prevented tracheal intubation in acute exacerbation of COPD patients significantly 26 vs 71 compared to standard medical therapy17
Randomized control study conducted by laurent etal suggested that non-invasive ventilation compared to standard medical treatment for COPD exacerbation could reduce the intubation rates length of stay in hospital18 Another study by plant et Al replicated the same results that early NIV therapy would reduce the number of intubation needed in mild to moderate exacerbation of COPD patients and improvement in paco2 and respiratory rate This study suggested that NIV therapy can be effectively administered in general respiratory wards also19
NIV therapy was used in hypoxemic respiratory failure in post-abdominal surgery patients compared with oxygen therapy alone by jaber et Al NIV therapy has significantly reduced tracheal reintubation rates within 7 days following surgery 331 vs 455 p value - 003 and also it provided more invasive ventilation free days compared with standard oxygen therapy254 vs 232 days Gas exchange was found to be similar with NIV and standard oxygen therapy in hypoxemic respiratory failure in this study Also the NIV group had fewer pulmonary infections compared with oxygen therapy group20
A randomized study by Nava et Al conducted to study the effectiveness of NIV to prevent reintubation suggested that early institution of NIV after extubation especially in high risk patients ie COPD Cardiac failure hypercapneic patients may prevent reintubation rates448 vs 1249 p-value-0027 The delayed delivery of NIV after extubation can cause increase in mortality So timely delivery of NIV support can reduce mortality upto 60 In this study NIV support was given atleast 8 hoursday after extubation21
Patient-ventilator asynchrony is well known in patients who are mechanically ventilated Although there are no studies that suggest direct patient related outcome due to asynchrony it is well known patient-ventilator asynchrony prolong the duration of mechanical ventilation22 Although correlation with oesophageal pressure is the standard way of detecting the patient-ventilator asynchrony a trained eye can detect most of the asynchronies using pressure-time or flow-time waveform analysis23Multiple studies has suggested better patient-ventilator interactions with adaptive support mode of ventilation requiring less manipulations from the clinician and also facilitating early liberation from mechanical ventilation compared to other modes of ventilation24-26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None