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

Not Applicable

Completed

• Conditions: COVID-19; Virus; Pneumonia; Atelectasis

• Registration Number: NCT04360837
• Lead Sponsor: Szeged University

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.

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Study Start: 2020-05-06
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in global impedance	20 minutes	Estimation of change in global impedance (%) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Changes in lung compliance	20 minutes	Estimation of change in compliance (ml/cmH2O) from the beginning to end of of the incremental/decremental PEEP alveolar recruitment.
Change in recruitability	7 days	Estimation of change in global impedance (%) on a daily manner.

Secondary Outcome Measures

Name	Time	Method
Plateau pressure	20 minutes and 7 days	Change in plateau pressure (cmH2O) following recruitment
Antero-to-posterior ventilation ratio	20 minutes and 7 days	Change in antero-to-posterior ventilation ratio (%) following intervention
Center of ventilation	20 minutes and 7 days	Change in center of ventilation (%) following intervention
Global inhomogeneity index	20 minutes and 7 days	Change in global inhomogeneity index (%) following intervention
Gas exchange	20 minutes and 7 days	Change in arterial partial pressure of oxygen (PaO2) (mmHg) following recruitment
End expiratory lung impedance (EELI)	20 minutes and 7 days	Change in end expiratory lung impedance (%)

Trial Locations

Locations (1)

University of Szeged; 🇭🇺 Szeged, Hungary