COVID-19NCT04360837
PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill Corona Virus Disease-19 (COVID-19) Patients
A study testing alveolar recruitment in people with COVID-19 and Virus; Pneumonia, run by Szeged University at 1 site in Hungary.
Trial summary
COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition due to hypoxemic respiratory failure with the background of viral pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COVID-19, Virus; Pneumonia, Atelectasis
- What is being tested?
- alveolar recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteHungary
- Study dates
- 6 May 2020to 1 Jul 2020
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SARS-CoV-2 positivity confirmed by polymerase chain reaction
- orotracheally intubated patients
- pressure control ventilation mode
- sedation level of minimum -4 on the Richmond Agitation Sedation Scale (RASS)
Who cannot join
- age under 18
- pregnancy
- pulmonectomy, lung resection in the past medical history
- clinically end stage chronic obstructive pulmonary disease
- sever hemodynamic instability (vasopressor refractory shock)
- sever bullous emphysema and/or spontaneous pneumothorax in the past medical history chest drainage in situ due to pneumothorax and/or bronchopleural fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)
COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition due to hypoxemic respiratory failure with the background of viral pneumonia. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the elimination of atelectasis developed by inflammation in the lung parenchyma The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations.
Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside.
Read the detailed description
COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition in 5% of the cases due to hypoxemic respiratory failure with the background of viral pneumonia. 90% of these patients require invasive mechanical ventilation on critical care units. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the eliminitaion of atelectasis developed by inflammation in the lung parenchyma.
The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations.
Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside. With the help of EIT, intrathoracic impedance changes, resulting from air and blood volume variations, can be determined by circumferentially attached surface electrodes around the thorax, applying small alternating currents and measuring differences in surface potentials. The calculated difference in potential is utilised to reconstruct impedance images what is employed to assess ventilation and perfusion distribution. Several local and global variances can be estimated just like the ratio fo atelectatic/overdistended alveoli, the ratio of aeration in the anterior/posterior regions, the inhomogeneity of aeration or regional compliance.
- Conditions
- COVID-19, Virus; Pneumonia, Atelectasis
- Being tested
- alveolar recruitment
- Medical subject headings
- COVID-19, Pneumonia, Viral, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitmentProcedure or surgery
incremental and decremental positive end-expiratory pressure alveolar recruitment
| Study group | Role | What they receive |
|---|---|---|
| PEEP incremental-decremental alveolar recruitment | Experimental | 1. installing EIT belt over the chest at the level of the 5th intercostal space and adjustment of the default recruitment settings in pressure control ventilation mode: pressure control 15 cmH20, PEEP 10 cmH2O, fraction of inspired oxygen (FiO2) and respiratory rate according to the discretion of the attending physician, recording basal parameters
2. implementation of recruitment:
* increment phase: increasing PEEP by 3 cmH2O in every two minutes from 10 cmH2O until top of PEEP 25 cmH2O
* decrement phase: decreasing PEEP by 3 cmH20 in every two minutes from 25 cmH20 until the basal PEEP 10 cmH20
* end inspiratory hold manoeuvre at every PEEP level
3. recording closing parameters
Repeating the above detailed intervention once daily as long as the patient is controlled ventilation. Receives: Procedure: alveolar recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lung compliance
Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Measured: 20 minutes
Change in global impedance
Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Measured: 20 minutes
Change in recruitability
Estimation of change in global impedance (%) on a daily manner.
Measured: 7 days
Secondary outcomes (6)
Gas exchange
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
Measured: 20 minutes and 7 days
Plateau pressure
Change in plateau pressure (cmH2O) following recruitment
Measured: 20 minutes and 7 days
End expiratory lung impedance (EELI)
Change in end expiratory lung impedance (%)
Measured: 20 minutes and 7 days
Antero-to-posterior ventilation ratio
Change in antero-to-posterior ventilation ratio (%) following intervention
Measured: 20 minutes and 7 days
Center of ventilation
Change in center of ventilation (%) following intervention
Measured: 20 minutes and 7 days
Global inhomogeneity index
Change in global inhomogeneity index (%) following intervention
Measured: 20 minutes and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start6 May 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Hochschule Furtwangen University, Budapest University of Technology and Economics
- Responsible party
- Principal investigator, András Lovas, Szeged University
- Investigators
- András Lovas, MD PhD, Principal investigator, SZTE AITI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360837
- Sponsor's protocol ID
- COVID-19EIT
- Status last verified
- Feb 2022
- First submitted
- 22 Apr 2020
- Last updated
- 15 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
PubMed 16641394Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PubMed 27596161Lovas A, Hankovszky P, Korsos A, Kupcsulik S, Molnar T, Szabo Z, Babik B. [Importance of the imaging techniques in the management of COVID-19-infected patients]. Orv Hetil. 2020 Apr 1;161(17):672-677. doi: 10.1556/650.2020.31814. Hungarian.
PubMed 32324360Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
PubMed 32250385Lovas A, Chen R, Molnar T, Benyo B, Szlavecz A, Hawchar F, Kruger-Ziolek S, Moller K. Differentiating Phenotypes of Coronavirus Disease-2019 Pneumonia by Electric Impedance Tomography. Front Med (Lausanne). 2022 May 19;9:747570. doi: 10.3389/fmed.2022.747570. eCollection 2022.
PubMed 35665323
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)
- ClinicalTrials.gov ID
- NCT04360837
- Acronym / sponsor ID
- COVID-19EIT
- Conditions
- COVID-19, Virus; Pneumonia, Atelectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Hochschule Furtwangen University, Budapest University of Technology and Economics
- Study start
- 6 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 24 Apr 2020 (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.
COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition due to hypoxemic respiratory failure with the background of viral pneumonia. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the elimination of atelectasis developed by inflammation in the lung parenchyma The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations.
Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside.
Detailed description
COVID-19 originated from Severe Acut Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection leads to critical condition in 5% of the cases due to hypoxemic respiratory failure with the background of viral pneumonia. 90% of these patients require invasive mechanical ventilation on critical care units. Both alevolar recruitment and the subsequent optimal positive end-expiratory pressure (PEEP) adjustment has a pivotal role in the eliminitaion of atelectasis developed by inflammation in the lung parenchyma.
The gold standard of the follow up of recruitment manoeuvre is the chest computed tomography (CT) examination. However, reduction of intrahospital transport and the exposure with healthcare workers are recommended because of the extremely virulent pathogen spreading easily by droplet infection. In this case bedside investigations have an utmost importance in the management of hygiene regulations.
Electric impedance tomography (EIT) is a non-invasive, radiation free functional imaging technique easily applicable at the bedside. With the help of EIT, intrathoracic impedance changes, resulting from air and blood volume variations, can be determined by circumferentially attached surface electrodes around the thorax, applying small alternating currents and measuring differences in surface potentials. The calculated difference in potential is utilised to reconstruct impedance images what is employed to assess ventilation and perfusion distribution. Several local and global variances can be estimated just like the ratio fo atelectatic/overdistended alveoli, the ratio of aeration in the anterior/posterior regions, the inhomogeneity of aeration or regional compliance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEEP incremental-decremental alveolar recruitment | Experimental | Procedure: alveolar recruitment1. installing EIT belt over the chest at the level of the 5th intercostal space and adjustment of the default recruitment settings in pressure control ventilation mode: pressure control 15 cmH20, PEEP 10 cmH2O, fraction of inspired oxygen (FiO2) and respiratory rate according to the discretion of the attending physician, recording basal parameters 2. implementation of recruitment: * increment phase: increasing PEEP by 3 cmH2O in every two minutes from 10 cmH2O until top of PEEP 25 cmH2O * decrement phase: decreasing PEEP by 3 cmH20 in every two minutes from 25 cmH20 until the basal PEEP 10 cmH20 * end inspiratory hold manoeuvre at every PEEP level 3. recording closing parameters Repeating the above detailed intervention once daily as long as the patient is controlled ventilation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SARS-CoV-2 positivity confirmed by polymerase chain reaction
- orotracheally intubated patients
- pressure control ventilation mode
- sedation level of minimum -4 on the Richmond Agitation Sedation Scale (RASS)
Key exclusion criteria (6 listed)
- age under 18
- pregnancy
- pulmonectomy, lung resection in the past medical history
- clinically end stage chronic obstructive pulmonary disease
- sever hemodynamic instability (vasopressor refractory shock)
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 |
|---|---|---|
| alveolar recruitmentincremental and decremental positive end-expiratory pressure alveolar recruitment | Procedure or surgery | PEEP incremental-decremental alveolar recruitment |
Primary outcome
Changes in lung compliance
Time frame: 20 minutes
Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Change in global impedance
Time frame: 20 minutes
Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Change in recruitability
Time frame: 7 days
Estimation of change in global impedance (%) on a daily manner.
6 secondary outcomes
Gas exchange
Time frame: 20 minutes and 7 days
Plateau pressure
Time frame: 20 minutes and 7 days
End expiratory lung impedance (EELI)
Time frame: 20 minutes and 7 days
Antero-to-posterior ventilation ratio
Time frame: 20 minutes and 7 days
Center of ventilation
Time frame: 20 minutes and 7 days
Global inhomogeneity index
Time frame: 20 minutes and 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 16641394Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
- Background: PubMed 27596161Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
- Background: PubMed 32324360Lovas A, Hankovszky P, Korsos A, Kupcsulik S, Molnar T, Szabo Z, Babik B. [Importance of the imaging techniques in the management of COVID-19-infected patients]. Orv Hetil. 2020 Apr 1;161(17):672-677. doi: 10.1556/650.2020.31814. Hungarian.
- Results publication: PubMed 32250385Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.
- Derived from this study: PubMed 35665323Lovas A, Chen R, Molnar T, Benyo B, Szlavecz A, Hawchar F, Kruger-Ziolek S, Moller K. Differentiating Phenotypes of Coronavirus Disease-2019 Pneumonia by Electric Impedance Tomography. Front Med (Lausanne). 2022 May 19;9:747570. doi: 10.3389/fmed.2022.747570. eCollection 2022.
- 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.
András Lovas, MD PhD principal investigator
SZTE AITI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar recruitment in people with COVID-19 and Virus; Pneumonia, run by Szeged University at 1 site in Hungary.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 15 Feb 2022. 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 Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lung compliance (time frame: 20 minutes). The study lists 3 primary outcomes in all. 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 NCT04360837, which also lists 5 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 15 Feb 2022.