NCT04360837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

May 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

April 22, 2020

Last Update Submit

February 11, 2022

Conditions

COVID-19Virus; PneumoniaAtelectasis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Change in recruitability

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

    7 days

Secondary Outcomes (6)

  • Gas exchange

    20 minutes and 7 days

  • Plateau pressure

    20 minutes and 7 days

  • End expiratory lung impedance (EELI)

    20 minutes and 7 days

  • Antero-to-posterior ventilation ratio

    20 minutes and 7 days

  • Center of ventilation

    20 minutes and 7 days

  • +1 more secondary outcomes

Study Arms (1)

PEEP incremental-decremental alveolar recruitment

EXPERIMENTAL

1. 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 2. 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 3. recording closing parameters Repeating the above detailed intervention once daily as long as the patient is controlled ventilation.

Procedure: alveolar recruitment

Interventions

alveolar recruitmentPROCEDURE

incremental and decremental positive end-expiratory pressure alveolar recruitment

PEEP incremental-decremental alveolar recruitment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Szeged

Szeged, 6725, Hungary

Location

Related Publications (5)

  • 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.

    PMID: 16641394BACKGROUND

  • 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.

    PMID: 27596161BACKGROUND

  • 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.

    PMID: 32324360BACKGROUND

  • 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.

    PMID: 32250385RESULT

  • 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.

    PMID: 35665323DERIVED

MeSH Terms

Conditions

COVID-19Pneumonia, ViralPulmonary Atelectasis

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • András Lovas, MD PhD

    SZTE AITI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultatnt in critical care and anaesthesiology

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

May 6, 2020

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)