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Status unknownNCT05781802Updated Mar 27, 2023

V/Q Matching in Pressure Support Ventilation

An observational study in Acute Respiratory Failure, ARDS and Electrical Impedance Tomography, sponsored by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-27.

Sponsored by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Spontaneous breathing during mechanical ventilation has been attributed to both protective and negative effects on patient outcomes, largely varying based on the severity of lung injury. Indeed, in severe ARDS the avoidance of spontaneous efforts has an established protective role. However, spontaneous breathing promotes the distribution of tidal volume towards the dependent lung, and low levels of support pressure determine more homogeneous ventilation in patients recovering from ARDS, compared to higher support levels. Physiology supports the potential of spontaneous breathing to increase lung perfusion, through the decrease of intra-thoracic pressure leading to an increased venous return. This mechanism, in absence of right ventricular dysfunction, may lead to increased global lung perfusion. Furthermore, gas exchange improvements in experimental lung injury models during pressure support vs. controlled ventilation have been explained with redistribution of lung perfusion to nondependent lung areas and improvement of V/Q matching even in absence of significant lung recruitment.

Electrical impedance tomography has been clinically used as a non-invasive tool to assess V/Q matching in patients with ARDS and to compare V/Q matching prior to and after a cycle of prone position in spontaneously breathing patients with COVID-19.

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.

02

Conditions studied

  • Acute Respiratory Failure
  • ARDS
  • Electrical Impedance Tomography

Keywords

  • Electrical impedance tomography
  • ARDS
  • V/Q matching
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adult mechanically ventilated patients with ARDS

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

    Other: Level of pressure support

Interventions

  • OtherLevel of pressure support

    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.

06

What researchers measure

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)

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

Secondary outcomes

  1. Changes in gas exchange

    Changes in gas exchange measured by blood gas analysis between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)

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

  2. Changes in regional ventilation distribution

    Changes in regional ventilation distribution between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)

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

  3. Changes in regional perfusion distribution

    Changes in regional perfusion distribution between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)

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

07

Study locations

1 of 1 sites recruiting
  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo
    Palermo, Italy
    • Mariachiara Ippolito, MD · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27786562 ↗
  • 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. PubMed 20843245 ↗
  • 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. PubMed 12883410 ↗
  • 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. PubMed 23507723 ↗
  • 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. PubMed 21270348 ↗
  • 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. PubMed 19690258 ↗
  • 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. PubMed 34453622 ↗
  • 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. PubMed 34082795 ↗
  • 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. PubMed 35768877 ↗
  • 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. PubMed 31694692 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05781802
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Responsible party
Andrea Cortegiani, MD (Clinical Professor, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo) — Principal investigator
First posted
Mar 23, 2023
Start date
Feb 27, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Mar 27, 2023

Study contacts

Mariachiara ippolito, MD
Contact
ippolito.mariachiara@gmail.com
00390916552700
Andrea Cortegiani, MD
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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