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

• ClinicalTrials.gov Identifier: NCT04360837
• Recruitment Status: Recruiting
• First Posted: April 24, 2020
• Last Update Posted: May 21, 2020
• Sponsor: Szeged University
• Collaborators: Furtwangen University; BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS
• Information provided by (Responsible Party): András Lovas, Szeged University

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.

Condition or disease	Intervention/treatment	Phase
COVID-19; Virus; Pneumonia; Atelectasis	Procedure: alveolar recruitment	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PEEP Incremental and Decremental Alveolar Recruitment of Critically Ill COVID-19 Patients Under Electric Impedance Tomography (EIT)
• Actual Study Start Date: May 6, 2020
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: PEEP incremental-decremental alveolar recruitment; 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.

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: András Lovas, MD PhD; 003662545168; lovas.andras@med.u-szeged.hu

Locations

Hungary

University of Szeged; Recruiting

Szeged, Hungary, 6725

Contact: András Lovas, MD

Sponsors and Collaborators

Szeged University

Furtwangen University

BUDAPEST UNIVERSITY OF TECHNOLOGY AND ECONOMICS

Investigators

• Principal Investigator: András Lovas, MD PhD; SZTE AITI

More Information

Publications of Results:

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.

Other 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.

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.

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.

• Responsible Party: András Lovas, consultatnt in critical care and anaesthesiology, Szeged University
• ClinicalTrials.gov Identifier: NCT04360837
• Other Study ID Numbers: COVID-19EIT
• First Posted: April 24, 2020
• Last Update Posted: May 21, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Pneumonia, Viral; Pneumonia; Pulmonary Atelectasis; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Virus Diseases