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

COVID-19 Clinical Trial

Official title:

PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04360837
• Other study ID #: COVID-19EIT
• Status: Completed
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2022
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• COVID-19
• Pneumonia, Viral
• Pulmonary Atelectasis
• Virus; Pneumonia

Intervention

Procedure:
• alveolar recruitment
incremental and decremental positive end-expiratory pressure alveolar recruitment

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged

Sponsors (3)

Lead Sponsor	Collaborator
Szeged University	Budapest University of Technology and Economics, Hochschule Furtwangen University

Country where clinical trial is conducted

Hungary, 

References & Publications (4)

Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Böhm 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. Review. — View 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. — View 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 Lomb — View Citation

Lovas A, Hankovszky P, Korsós A, Kupcsulik S, Molnár T, Szabó 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. Review. Hungarian. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in lung compliance	Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.	20 minutes
Primary	Change in global impedance	Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.	20 minutes
Primary	Change in recruitability	Estimation of change in global impedance (%) on a daily manner.	7 days
Secondary	Gas exchange	Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment	20 minutes and 7 days
Secondary	Plateau pressure	Change in plateau pressure (cmH2O) following recruitment	20 minutes and 7 days
Secondary	End expiratory lung impedance (EELI)	Change in end expiratory lung impedance (%)	20 minutes and 7 days
Secondary	Antero-to-posterior ventilation ratio	Change in antero-to-posterior ventilation ratio (%) following intervention	20 minutes and 7 days
Secondary	Center of ventilation	Change in center of ventilation (%) following intervention	20 minutes and 7 days
Secondary	Global inhomogeneity index	Change in global inhomogeneity index (%) following intervention	20 minutes and 7 days