Acute Respiratory FailureNCT05781802
V/Q Matching in Pressure Support Ventilation
An observational study of Acute Respiratory Failure and ARDS, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, ARDS, Electrical Impedance Tomography
- What is being tested?
- Level of pressure support
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who were admitted to ICU with acute respiratory distress syndrome (ARDS) or developing it during ICU stay.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Andrea Cortegiani, MD contact
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo
Palermo
Mariachiara Ippolito, MD
About this study
Official title: Assessment of V/Q Matching During Pressure Support Ventilation With Electrical Impedance Tomography
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.
- Being tested
- Level of pressure support
- Keywords
- Electrical impedance tomography, ARDS, V/Q matching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level of pressure supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult mechanically ventilated patients with ARDS | Adult mechanically ventilated patients with ARDS (see inclusion/exclusion criteria) Receives: Other: Level of pressure support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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)
Measured: 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
Changes in regional ventilation distribution between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)
Measured: 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
Changes in regional perfusion distribution between the two different levels of pressure support ("high" level of pressure support and "low" level of pressure support)
Measured: Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start27 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Cortegiani, MD, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781802
- Sponsor's protocol ID
- EIT01
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27786562Papazian 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 20843245Wrigge 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 12883410Mauri 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 23507723Carvalho 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 21270348Carvalho 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 19690258He 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 34453622Spinelli 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 34082795Liu 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 35768877Bertoni 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of V/Q Matching During Pressure Support Ventilation With Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT05781802
- Acronym / sponsor ID
- EIT01
- Keywords
- Electrical impedance tomography, ARDS, V/Q matching
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult mechanically ventilated patients with ARDS | – | Other: Level of pressure supportAdult mechanically ventilated patients with ARDS (see inclusion/exclusion criteria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were admitted to ICU with acute respiratory distress syndrome (ARDS) or developing it during ICU stay.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level of pressure supportPatients 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. | Other | Adult mechanically ventilated patients with ARDS |
Primary outcome
Changes in ventilation-perfusion matching
Time frame: 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)
3 secondary outcomes
Changes in gas exchange
Time frame: 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
Time frame: 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
Time frame: Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 27786562Yoshida 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.
- Background: PubMed 20843245Papazian 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.
- Background: PubMed 12883410Wrigge 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.
- Background: PubMed 23507723Mauri 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.
- Background: PubMed 21270348Carvalho 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.
- Background: PubMed 19690258Carvalho 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.
- Background: PubMed 34453622He 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.
- Background: PubMed 34082795Spinelli 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.
- Background: PubMed 35768877Liu 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.
- Background: PubMed 31694692Bertoni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Cortegiani, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and ARDS, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariachiara ippolito, MD (00390916552700, ippolito.mariachiara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ventilation-perfusion matching (time frame: Measured after at least 20 minutes from the application of each of the levels of pressure support and at clinical stability). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05781802, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.