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

NCT ID: NCT04360837

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-06

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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COVID-19 Virus; Pneumonia Atelectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PEEP incremental-decremental alveolar recruitment

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.

Group Type EXPERIMENTAL

alveolar recruitment

Intervention Type PROCEDURE

incremental and decremental positive end-expiratory pressure alveolar recruitment

Interventions

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alveolar recruitment

incremental and decremental positive end-expiratory pressure alveolar recruitment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hochschule Furtwangen University

OTHER

Sponsor Role collaborator

Budapest University of Technology and Economics

OTHER

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role lead

Responsible Party

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András Lovas

consultatnt in critical care and anaesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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András Lovas, MD PhD

Role: PRINCIPAL_INVESTIGATOR

SZTE AITI

Locations

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University of Szeged

Szeged, , Hungary

Site Status

Countries

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Hungary

References

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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.

Reference Type BACKGROUND
PMID: 16641394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27596161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32324360 (View on PubMed)

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.

Reference Type RESULT
PMID: 32250385 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35665323 (View on PubMed)

Other Identifiers

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COVID-19EIT

Identifier Type: -

Identifier Source: org_study_id

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