Neural Pressure Support for Low Pulmonary Compliance

NCT ID: NCT05566652

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is an interventional prospective crossover physiological study that will take place at the Intensive Care Unit "E. Vecla", Department of Anesthesia, Intensive Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NPS

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Neural Pressure Support Ventilation.

Group Type EXPERIMENTAL

Neural Pressure Support

Intervention Type DEVICE

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Pressure Support Ventilation

Intervention Type DRUG

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

PSV

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing Pressure Support Ventilation.

Group Type SHAM_COMPARATOR

Neural Pressure Support

Intervention Type DEVICE

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Pressure Support Ventilation

Intervention Type DRUG

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Interventions

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Neural Pressure Support

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Intervention Type DEVICE

Pressure Support Ventilation

To evaluate WOB and asynchronies in patients with low respiratory system compliance undergoing either PSV and NPS.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giacomo Grasselli

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giacomo Grasselli, MD

Role: primary

+390255033285

References

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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.

Reference Type BACKGROUND
PMID: 28792873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34217425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27786562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34271958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28459336 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15691390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20083921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8339649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8636518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9196100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10846029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11133620 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16109983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16896854 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14739134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2643905 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11373508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11316635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31876624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33470654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32665426 (View on PubMed)

Other Identifiers

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NPS

Identifier Type: -

Identifier Source: org_study_id

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