Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography

O

Osaka University

Status

Completed

Conditions

Critical Illness
ARDS

Study type

Observational

Funder types

Other

Identifiers

NCT04473300
ASPEIT

Details and patient eligibility

About

Novel coronavirus (SARS-CoV-2: severe acute respiratory coronavirus 2) pneumonia often develop the acute respiratory distress syndrome (ARDS). Lung protective ventilation strategy consisting of low tidal volume and high positive end-expiratory pressure (PEEP) is recommended. However, it is not clear whether injured lungs from SARS-CoV-2 pneumonia have the same mechanical properties, especially response to PEEP as common ARDS. Therefore, the investigators propose an observational study to analyze respiratory mechanics and lung recruitablity using EIT (electrical impedance tomography) in patients with ARDS due to SARS-CoV-2 pneumonia.

Full description

The multi-center prospective observational study will enroll 20 adult ARDS patients under mechanical ventilation from Intensive Care Units (ICUs) in Japan and Peru. Informed consent will be waived due to the nature of observational study. Patients with positive SARS-CoV-2 infection will be included. Prior to initiating the protocol, patients will be sedated deeply with sedatives and/or opioids and paralyzed with a continuous infusion of rocuronium. The distribution of ventilation will be evaluated with EIT.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with positive SARS-CoV-2 infection*
  • Patients with ARDS under mechanical ventilation**

Patients ≧ 18 years old

Definition of SARS-CoV-2 infection positive: SARS-CoV-2 infection is defined as being positive in RT-PCR (real time reverse transcriptase-polymerase chain reaction) assay using nasal or pharyngeal swab samples.

Definition of ARDS is as per the Berlin definition (PaO2/FiO2 ≦ 300 mmHg with PEEP ≧ 5 cmH2O)

Exclusion criteria

Contraindication for EIT monitoring

  • Unstable spine or pelvic fractures
  • Pacemaker, automatic implantable cardioverter defibrillator
  • Skin lesions between the 4th and 5th ribs where the EIT belt is worn
  • Home mechanical ventilation before inclusion
  • Pregnancy
  • DNR (do-not-resuscitate)
  • Increased intracranial pressure (> 18 mmHg)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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