Neural Pressure Support for Low Pulmonary Compliance

Acute Respiratory Failure Clinical Trial

— NPS_LowCrs  

Official title:

Neural Pressure Support for Low Pulmonary Compliance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566652
• Other study ID #: NPS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2022
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Acute respiratory failure (ARF) is a critical condition caused by impaired function of the lungs.1,2 The cornerstone of ARF management is invasive mechanical ventilation (IMV).3,4 Unfortunately, despite lifesaving, IMV is associated with several side effects (e.g., ventilator-associated pneumonia, ventilator associate induced lung injury, diaphragmatic dysfunction), and thus liberation from invasive mechanical ventilation is an everyday effort for critical care physicians.5

Pressure support ventilation (PSV) is one of the most widely used mechanical ventilation modes for liberation from IMV.6 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 flow.7 The termination of the breath occurs when the inspiratory flow falls to a predetermined fraction of the peak inspiratory flow.8

The main goal of mechanical ventilation is to help restore gas exchange and reduce the work of breathing (WOB) by assisting respiratory muscle activity.9 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 muscles.10

Ideally, the ventilator trigger and cycling should coincide with the beginning and end of the patient's inspiratory effort.11 However, patient-ventilator asynchrony is common during PSV,12,13 thereby contributing to an increased work of breathing and an increased duration of mechanical ventilation.14

An important objective of assisted or patient-triggered mechanical ventilation is to avoid ventilator-induced diaphragmatic dysfunction by allowing the patient to generate spontaneous efforts.15 A second objective is to reduce the patient's work of breathing by delivering a sufficient level of ventilatory support.16 Finally, intuition suggests that a good match between patient respiratory efforts and ventilator breaths optimizes patient comfort and reduces work of breathing.17 Patient-ventilator asynchrony can be defined as a mismatch between the patient and ventilator inspiratory and expiratory times.18 Although inspiratory and expiratory delays are almost inevitable with most ventilatory modes, several patterns of major asynchrony exist and can be easily detected by clinicians.14

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 electrodes.19

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 patient's efforts.20

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 asynchronies.21 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Admission to Intensive Care Unit (ICU) for ARF

• Low compliance of the respiratory system (Crs = 30 ml/cmH2O)

• Written informed consent obtained

Exclusion Criteria:

• Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)

• Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., International Normalized Ratio (INR) > 2 and platelets count < 70.000/mm3)

• Severe hemodynamic instability (noradrenaline > 0.3 µg/kg/min and/or use of vasopressin)

• Failure to obtain a stable EAdi signal

• Central nervous system or neuromuscular disorders

• Moribund status

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Neural Pressure Support
To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Drug:
• Pressure Support Ventilation
To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (21)

Brochard L, Harf A, Lorino H, Lemaire F. Inspiratory pressure support prevents diaphragmatic fatigue during weaning from mechanical ventilation. Am Rev Respir Dis. 1989 Feb;139(2):513-21. doi: 10.1164/ajrccm/139.2.513. — View Citation

Dres M, Demoule A. Monitoring diaphragm function in the ICU. Curr Opin Crit Care. 2020 Feb;26(1):18-25. doi: 10.1097/MCC.0000000000000682. — View Citation

Fan E, Del Sorbo L, Goligher EC, Hodgson CL, Munshi L, Walkey AJ, Adhikari NKJ, Amato MBP, Branson R, Brower RG, Ferguson ND, Gajic O, Gattinoni L, Hess D, Mancebo J, Meade MO, McAuley DF, Pesenti A, Ranieri VM, Rubenfeld GD, Rubin E, Seckel M, Slutsky AS, Talmor D, Thompson BT, Wunsch H, Uleryk E, Brozek J, Brochard LJ; American Thoracic Society, European Society of Intensive Care Medicine, and Society of Critical Care Medicine. An Official American Thoracic Society/European Society of Intensive Care Medicine/Society of Critical Care Medicine Clinical Practice Guideline: Mechanical Ventilation in Adult Patients with Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 May 1;195(9):1253-1263. doi: 10.1164/rccm.201703-0548ST. Erratum In: Am J Respir Crit Care Med. 2017 Jun 1;195(11):1540. — View Citation

Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6. — View Citation

Leung P, Jubran A, Tobin MJ. Comparison of assisted ventilator modes on triggering, patient effort, and dyspnea. Am J Respir Crit Care Med. 1997 Jun;155(6):1940-8. doi: 10.1164/ajrccm.155.6.9196100. — View Citation

Liu L, Xu XT, Yu Y, Sun Q, Yang Y, Qiu HB. Neural control of pressure support ventilation improved patient-ventilator synchrony in patients with different respiratory system mechanical properties: a prospective, crossover trial. Chin Med J (Engl). 2021 Jan 19;134(3):281-291. doi: 10.1097/CM9.0000000000001357. — View Citation

MacIntyre NR. Clinically available new strategies for mechanical ventilatory support. Chest. 1993 Aug;104(2):560-5. doi: 10.1378/chest.104.2.560. No abstract available. — View Citation

Meyer NJ, Gattinoni L, Calfee CS. Acute respiratory distress syndrome. Lancet. 2021 Aug 14;398(10300):622-637. doi: 10.1016/S0140-6736(21)00439-6. Epub 2021 Jul 1. — View Citation

Mirabella L, Cinnella G, Costa R, Cortegiani A, Tullo L, Rauseo M, Conti G, Gregoretti C. Patient-Ventilator Asynchronies: Clinical Implications and Practical Solutions. Respir Care. 2020 Nov;65(11):1751-1766. doi: 10.4187/respcare.07284. Epub 2020 Jul 14. — View Citation

Nava S, Bruschi C, Rubini F, Palo A, Iotti G, Braschi A. Respiratory response and inspiratory effort during pressure support ventilation in COPD patients. Intensive Care Med. 1995 Nov;21(11):871-9. doi: 10.1007/BF01712327. — View Citation

Pelosi P, Ball L, Barbas CSV, Bellomo R, Burns KEA, Einav S, Gattinoni L, Laffey JG, Marini JJ, Myatra SN, Schultz MJ, Teboul JL, Rocco PRM. Personalized mechanical ventilation in acute respiratory distress syndrome. Crit Care. 2021 Jul 16;25(1):250. doi: 10.1186/s13054-021-03686-3. — View Citation

Sassoon CS, Foster GT. Patient-ventilator asynchrony. Curr Opin Crit Care. 2001 Feb;7(1):28-33. doi: 10.1097/00075198-200102000-00005. — View Citation

Spahija J, de Marchie M, Albert M, Bellemare P, Delisle S, Beck J, Sinderby C. Patient-ventilator interaction during pressure support ventilation and neurally adjusted ventilatory assist. Crit Care Med. 2010 Feb;38(2):518-26. doi: 10.1097/CCM.0b013e3181cb0d7b. — View Citation

Tassaux D, Gainnier M, Battisti A, Jolliet P. Impact of expiratory trigger setting on delayed cycling and inspiratory muscle workload. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1283-9. doi: 10.1164/rccm.200407-880OC. Epub 2005 Aug 18. — View Citation

Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L. Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. doi: 10.1007/s00134-006-0301-8. Epub 2006 Aug 1. — View Citation

Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available. — View Citation

Tobin MJ, Jubran A, Laghi F. Patient-ventilator interaction. Am J Respir Crit Care Med. 2001 Apr;163(5):1059-63. doi: 10.1164/ajrccm.163.5.2005125. No abstract available. — View Citation

Tokioka H, Tanaka T, Ishizu T, Fukushima T, Iwaki T, Nakamura Y, Kosogabe Y. The effect of breath termination criterion on breathing patterns and the work of breathing during pressure support ventilation. Anesth Analg. 2001 Jan;92(1):161-5. doi: 10.1097/00000539-200101000-00031. — View Citation

Vassilakopoulos T, Petrof BJ. Ventilator-induced diaphragmatic dysfunction. Am J Respir Crit Care Med. 2004 Feb 1;169(3):336-41. doi: 10.1164/rccm.200304-489CP. No abstract available. — View Citation

Yamada Y, Du HL. Analysis of the mechanisms of expiratory asynchrony in pressure support ventilation: a mathematical approach. J Appl Physiol (1985). 2000 Jun;88(6):2143-50. doi: 10.1152/jappl.2000.88.6.2143. — View Citation

Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Of Breathing (WOB)	We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the patient's work of breathing (WOB). WOB will be evaluated by the off-line analysis of the esophageal pressure waveform.	30 minutes ventilatory traces recording
Secondary	Asynchronies	We hypothesize that Neural Pressure Support (NPS) is able to improve the patient-ventilator interaction, thus reducing significantly the asynchronies between patient and ventilator. Asynchronies will be estimated by the Asynchrony Index (AI) calculated off-line by ventilatory waveforms analysis.	30 minutes ventilatory traces recording