V/Q Matching in Pressure Support Ventilation

Sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05781802
Collaborator
(none)
15
1
10.1
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Level of pressure support

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of V/Q Matching During Pressure Support Ventilation With Electrical Impedance Tomography
Actual Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Adult mechanically ventilated patients with ARDS

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

Other: Level 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.

Outcome Measures

Primary Outcome Measures

  1. Changes in ventilation-perfusion matching [Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability]

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

Secondary Outcome Measures

  1. 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 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)

  2. 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 ventilation distribution between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)

  3. 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]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo Palermo Italy

Sponsors and Collaborators

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Andrea Cortegiani, MD, Clinical Professor, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
ClinicalTrials.gov Identifier:
NCT05781802
Other Study ID Numbers:
  • EIT01
First Posted:
Mar 23, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Andrea Cortegiani, MD, Clinical Professor, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2023