Neural Pressure Support for Low Pulmonary Compliance

NCT05566652 | Unknown DMC

• 1 other identifier: NPS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

NPS; WOB; AI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asynchronies

  30 minutes ventilatory traces recording

Study Arms (2)

NPS

EXPERIMENTAL

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

Device: Neural Pressure Support; Drug: Pressure Support Ventilation

PSV

SHAM COMPARATOR

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

Device: Neural Pressure Support; Drug: Pressure Support Ventilation

Interventions

Neural Pressure Support DEVICE

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

NPS; PSV

Pressure Support Ventilation DRUG

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

NPS; PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

RECRUITING

Related Publications (21)

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• 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.

  PMID: 34217425 BACKGROUND

• 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.

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• 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.

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• 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.

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  PMID: 8636518 BACKGROUND

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  PMID: 9196100 BACKGROUND

• 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.

  PMID: 10846029 BACKGROUND

• 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.

  PMID: 11133620 BACKGROUND

• 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.

  PMID: 16109983 BACKGROUND

• 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.

  PMID: 16896854 BACKGROUND

• 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.

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

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• 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.

  PMID: 11316635 BACKGROUND

• 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.

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• 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.

  PMID: 33470654 BACKGROUND

• 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.

  PMID: 32665426 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: October 4, 2022
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)