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PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill Corona Virus Disease-19 (COVID-19) Patients

Primary Purpose

COVID-19, Virus; Pneumonia, Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
alveolar recruitment
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Szeged

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEEP incremental-decremental alveolar recruitment

Arm Description

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 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 recording closing parameters Repeating the above detailed intervention once daily as long as the patient is controlled ventilation.

Outcomes

Primary Outcome Measures

Changes in lung compliance
Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Change in global impedance
Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Change in recruitability
Estimation of change in global impedance (%) on a daily manner.

Secondary Outcome Measures

Gas exchange
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
Plateau pressure
Change in plateau pressure (cmH2O) following recruitment
End expiratory lung impedance (EELI)
Change in end expiratory lung impedance (%)
Antero-to-posterior ventilation ratio
Change in antero-to-posterior ventilation ratio (%) following intervention
Center of ventilation
Change in center of ventilation (%) following intervention
Global inhomogeneity index
Change in global inhomogeneity index (%) following intervention

Full Information

First Posted
April 22, 2020
Last Updated
February 11, 2022
Sponsor
Szeged University
Collaborators
Hochschule Furtwangen University, Budapest University of Technology and Economics
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1. Study Identification

Unique Protocol Identification Number
NCT04360837
Brief Title
PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill Corona Virus Disease-19 (COVID-19) Patients
Official Title
PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University
Collaborators
Hochschule Furtwangen University, Budapest University of Technology and Economics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Virus; Pneumonia, Atelectasis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEP incremental-decremental alveolar recruitment
Arm Type
Experimental
Arm Description
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 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 recording closing parameters Repeating the above detailed intervention once daily as long as the patient is controlled ventilation.
Intervention Type
Procedure
Intervention Name(s)
alveolar recruitment
Intervention Description
incremental and decremental positive end-expiratory pressure alveolar recruitment
Primary Outcome Measure Information:
Title
Changes in lung compliance
Description
Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Time Frame
20 minutes
Title
Change in global impedance
Description
Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Time Frame
20 minutes
Title
Change in recruitability
Description
Estimation of change in global impedance (%) on a daily manner.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Gas exchange
Description
Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
Time Frame
20 minutes and 7 days
Title
Plateau pressure
Description
Change in plateau pressure (cmH2O) following recruitment
Time Frame
20 minutes and 7 days
Title
End expiratory lung impedance (EELI)
Description
Change in end expiratory lung impedance (%)
Time Frame
20 minutes and 7 days
Title
Antero-to-posterior ventilation ratio
Description
Change in antero-to-posterior ventilation ratio (%) following intervention
Time Frame
20 minutes and 7 days
Title
Center of ventilation
Description
Change in center of ventilation (%) following intervention
Time Frame
20 minutes and 7 days
Title
Global inhomogeneity index
Description
Change in global inhomogeneity index (%) following intervention
Time Frame
20 minutes and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
András Lovas, MD PhD
Organizational Affiliation
SZTE AITI
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
6725
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16641394
Citation
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.
Results Reference
background
PubMed Identifier
27596161
Citation
Frerichs 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.
Results Reference
background
PubMed Identifier
32324360
Citation
Lovas 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 Reference
background
PubMed Identifier
32250385
Citation
Grasselli 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. Erratum In: JAMA. 2021 May 25;325(20):2120.
Results Reference
result
PubMed Identifier
35665323
Citation
Lovas 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.
Results Reference
derived

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PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill Corona Virus Disease-19 (COVID-19) Patients

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