V/Q Matching in Pressure Support Ventilation

NCT05781802 | Unknown

• 1 other identifier: EIT01
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to describe the effects of different levels of pressure support on ventilation-perfusion matching in patients recovering from ARDS, using electrical impedance tomography.

Conditions

Acute Respiratory Failure; ARDS; Electrical Impedance Tomography

Keywords

Electrical impedance tomography; ARDS; V/Q matching

Outcome Measures

Primary Outcomes (1)

• Changes in ventilation-perfusion matching

  Changes in ventilation-perfusion matching between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)

  Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability

Secondary Outcomes (3)

• Changes in gas exchange

  Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability

• Changes in regional ventilation distribution

  Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability

• Changes in regional perfusion distribution

  Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability

Study Arms (1)

Adult mechanically ventilated patients with ARDS

Adult mechanically ventilated patients with ARDS (see inclusion/exclusion criteria)

Other: Level of pressure support

Interventions

Level of pressure support OTHER

Patients will be evaluated in two different conditions sequentially. The first condition will be at a clinically selected level of pressure support under stable clinical conditions. This condition will be labeled according to P0.1: * In case of P0.1\<2, the clinically selected level of pressure support will be considered "High Pressure support". * In case of P0.1\>2, the clinically selected level of pressure support will be considered "Low Pressure support". After data collection at clinically selected level of pressure support, pressure support level will be transiently increased or decreased (i.e. from high to low/ from low to high) to the lowest/highest clinically tolerated level, aiming at the predefined P01 thresholds, and then kept for 20 minutes under stable clinical conditions. Data collection will be repeated and then the clinically selected level of pressure support restored.

Adult mechanically ventilated patients with ARDS

Eligibility Criteria

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

Study Population

Adult patients who were admitted to ICU with acute respiratory distress syndrome (ARDS) or developing it during ICU stay.

You may qualify if:

• Age ≥ 18 years
• Need for invasive mechanical ventilation and ICU admission
• Diagnosis of ARDS at ICU admission or during ICU stay
• Informed consent
• Presence of central line in the internal jugular vein

You may not qualify if:

• Any contraindication to Electrical impedance tomography monitoring (e. g. severe chest trauma or wounds)
• Cardiogenic pulmonary edema
• Pulmonary embolism
• Chronic obstructive pulmonary disease
• Pulmonary fibrosis
• Asthma exacerbation
• Pneumothorax and/or chest drainages
• Pre-existing diaphragmatic function impairment
• Neuro-muscular disease or impairment
• Moribund patients with limitation of care or expected survival \<48h according to the treating physician

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo

Palermo, Italy

RECRUITING

Related Publications (10)

• 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.

  PMID: 27786562 BACKGROUND

• Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

  PMID: 20843245 BACKGROUND

• Wrigge H, Zinserling J, Neumann P, Defosse J, Magnusson A, Putensen C, Hedenstierna G. Spontaneous breathing improves lung aeration in oleic acid-induced lung injury. Anesthesiology. 2003 Aug;99(2):376-84. doi: 10.1097/00000542-200308000-00019.

  PMID: 12883410 BACKGROUND

• Mauri T, Bellani G, Confalonieri A, Tagliabue P, Turella M, Coppadoro A, Citerio G, Patroniti N, Pesenti A. Topographic distribution of tidal ventilation in acute respiratory distress syndrome: effects of positive end-expiratory pressure and pressure support. Crit Care Med. 2013 Jul;41(7):1664-73. doi: 10.1097/CCM.0b013e318287f6e7.

  PMID: 23507723 BACKGROUND

• Carvalho AR, Spieth PM, Guldner A, Cuevas M, Carvalho NC, Beda A, Spieth S, Stroczynski C, Wiedemann B, Koch T, Pelosi P, de Abreu MG. Distribution of regional lung aeration and perfusion during conventional and noisy pressure support ventilation in experimental lung injury. J Appl Physiol (1985). 2011 Apr;110(4):1083-92. doi: 10.1152/japplphysiol.00804.2010. Epub 2011 Jan 26.

  PMID: 21270348 BACKGROUND

• Carvalho AR, Spieth PM, Pelosi P, Beda A, Lopes AJ, Neykova B, Heller AR, Koch T, Gama de Abreu M. Pressure support ventilation and biphasic positive airway pressure improve oxygenation by redistribution of pulmonary blood flow. Anesth Analg. 2009 Sep;109(3):856-65. doi: 10.1213/ane.0b013e3181aff245.

  PMID: 19690258 BACKGROUND

• He H, Chi Y, Long Y, Yuan S, Zhang R, Yang Y, Frerichs I, Moller K, Fu F, Zhao Z. Three broad classifications of acute respiratory failure etiologies based on regional ventilation and perfusion by electrical impedance tomography: a hypothesis-generating study. Ann Intensive Care. 2021 Aug 28;11(1):134. doi: 10.1186/s13613-021-00921-6.

  PMID: 34453622 BACKGROUND

• Spinelli E, Kircher M, Stender B, Ottaviani I, Basile MC, Marongiu I, Colussi G, Grasselli G, Pesenti A, Mauri T. Unmatched ventilation and perfusion measured by electrical impedance tomography predicts the outcome of ARDS. Crit Care. 2021 Jun 3;25(1):192. doi: 10.1186/s13054-021-03615-4.

  PMID: 34082795 BACKGROUND

• Liu L, Xie J, Wang C, Zhao Z, Chong Y, Yuan X, Qiu H, Zhao M, Yang Y, Slutsky AS. Prone position improves lung ventilation-perfusion matching in non-intubated COVID-19 patients: a prospective physiologic study. Crit Care. 2022 Jun 29;26(1):193. doi: 10.1186/s13054-022-04069-y. No abstract available.

  PMID: 35768877 BACKGROUND

• Bertoni M, Telias I, Urner M, Long M, Del Sorbo L, Fan E, Sinderby C, Beck J, Liu L, Qiu H, Wong J, Slutsky AS, Ferguson ND, Brochard LJ, Goligher EC. A novel non-invasive method to detect excessively high respiratory effort and dynamic transpulmonary driving pressure during mechanical ventilation. Crit Care. 2019 Nov 6;23(1):346. doi: 10.1186/s13054-019-2617-0.

  PMID: 31694692 BACKGROUND

Central Study Contacts

Mariachiara ippolito, MD

CONTACT

00390916552700; ippolito.mariachiara@gmail.com

Andrea Cortegiani, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 23, 2023
• Study Start: February 27, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)