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Completed

NCT Number: NCT04360837

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Szeged

Szeged, 6725, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alveolar recruitment

Procedure

incremental and decremental positive end-expiratory pressure alveolar recruitment

Primary outcomes

  1. 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.

  2. 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.

  3. Change in recruitability

    Time frame: 7 days

    Estimation of change in global impedance (%) on a daily manner.

Secondary outcomes

  1. Gas exchange

    Time frame: 20 minutes and 7 days

    Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment

  2. Plateau pressure

    Time frame: 20 minutes and 7 days

    Change in plateau pressure (cmH2O) following recruitment

  3. End expiratory lung impedance (EELI)

    Time frame: 20 minutes and 7 days

    Change in end expiratory lung impedance (%)

  4. Antero-to-posterior ventilation ratio

    Time frame: 20 minutes and 7 days

    Change in antero-to-posterior ventilation ratio (%) following intervention

  5. Center of ventilation

    Time frame: 20 minutes and 7 days

    Change in center of ventilation (%) following intervention

  6. Global inhomogeneity index

    Time frame: 20 minutes and 7 days

    Change in global inhomogeneity index (%) following intervention

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Collaborators

  • Budapest University of Technology and Economics
  • Hochschule Furtwangen University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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