Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05566652
Status:
RECRUITING
Last Update Posted:
2023-01-04
First Post:
2022-09-13
Brief Title:
Neural Pressure Support for Low Pulmonary Compliance
Sponsor:
Policlinico Hospital
Organization:
Policlinico Hospital
Study Overview
Official Title:
Neural Pressure Support for Low Pulmonary Compliance
Status:
RECRUITING
Status Verified Date:
2022-12
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:
NPS_LowCrs
Brief Summary:
With this interventional prospective study we aim at comparing the effectiveness of Neural Pressure Support NPS in reducing respiratory work and patient-ventilator asynchronies as compared with standard Pressure Support Ventilation PSV in a cohort of patients with Acute Respiratory Failure ARF and low respiratory system compliance
Detailed Description:
Acute respiratory failure ARF is a critical condition caused by impaired function of the lungs12 The cornerstone of ARF management is invasive mechanical ventilation IMV34 Unfortunately despite lifesaving IMV is associated with several side effects eg ventilator-associated pneumonia ventilator associate induced lung injury diaphragmatic dysfunction and thus liberation from invasive mechanical ventilation is an everyday effort for critical care physicians5
Pressure support ventilation PSV is one of the most widely used mechanical ventilation modes for liberation from IMV6 PSV is a partial ventilatory mode the ventilator and the patient co-operate to generate the inspiratory and expiratory pressures flows and volumes During conventional PSV the initiation of the breath is triggered by a reduction in expiratory pressure or a drop in expiratory flow7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow8
The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing WOB by assisting respiratory muscle activity9 Knowing the determinants of WOB is essential for the effective use of mechanical ventilation and also to assess patient readiness for weaning To reduce WOB PSV needs to be synchronous and smooth interaction should happen between the ventilator and the respiratory muscles10
Ideally the ventilator trigger and cycling should coincide with the beginning and end of the patients inspiratory effort11 However patient-ventilator asynchrony is common during PSV1213 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation14
An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts15 A second objective is to reduce the patients work of breathing by delivering a sufficient level of ventilatory support16 Finally intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes several patterns of major asynchrony exist and can be easily detected by clinicians14
The diaphragmatic electrical activity EAdi can be used to optimize the ventilator settings and improve the matching between patient and ventilator The EAdi signal is a surrogate of respiratory brain stem output and can be recorded using specialized nasogastric tubes equipped with electrodes19
The Neural Pressure Support NPS is a newer ventilation mode that includes neural trigger and termination of inspiration based on the electrical activity of the diaphragm Edi NPS delivers a constant airway pressure support independent of the patients efforts20
The NPS may be particularly beneficial for ARF patients with lower respiratory compliance Indeed in this cohort during standard PSV expiratory cycling may be hampered by several asynchronies21 However to our knowledge the effectiveness of NPS in reducing asynchronies and respiratory work has not been tested and compared with standard PSV in patients with low respiratory system compliance
Pressure support ventilation PSV is one of the most widely used mechanical ventilation modes for liberation from IMV6 PSV is a partial ventilatory mode the ventilator and the patient co-operate to generate the inspiratory and expiratory pressures flows and volumes During conventional PSV the initiation of the breath is triggered by a reduction in expiratory pressure or a drop in expiratory flow7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow8
The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing WOB by assisting respiratory muscle activity9 Knowing the determinants of WOB is essential for the effective use of mechanical ventilation and also to assess patient readiness for weaning To reduce WOB PSV needs to be synchronous and smooth interaction should happen between the ventilator and the respiratory muscles10
Ideally the ventilator trigger and cycling should coincide with the beginning and end of the patients inspiratory effort11 However patient-ventilator asynchrony is common during PSV1213 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation14
An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts15 A second objective is to reduce the patients work of breathing by delivering a sufficient level of ventilatory support16 Finally intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes several patterns of major asynchrony exist and can be easily detected by clinicians14
The diaphragmatic electrical activity EAdi can be used to optimize the ventilator settings and improve the matching between patient and ventilator The EAdi signal is a surrogate of respiratory brain stem output and can be recorded using specialized nasogastric tubes equipped with electrodes19
The Neural Pressure Support NPS is a newer ventilation mode that includes neural trigger and termination of inspiration based on the electrical activity of the diaphragm Edi NPS delivers a constant airway pressure support independent of the patients efforts20
The NPS may be particularly beneficial for ARF patients with lower respiratory compliance Indeed in this cohort during standard PSV expiratory cycling may be hampered by several asynchronies21 However to our knowledge the effectiveness of NPS in reducing asynchronies and respiratory work has not been tested and compared with standard PSV in patients with low respiratory system compliance
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