---
title: Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography
nct_id: NCT04473300
overall_status: COMPLETED
sponsor: Osaka University
study_type: OBSERVATIONAL
primary_condition: Critical Illness
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04473300.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04473300"
ct_last_update_post_date: 2021-07-01
last_seen_at: "2026-05-12T07:19:52.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography

**Official Title:** Assessment of Lung Recruitablity of Acute Respiratory Distress Syndrome With SARS-CoV-2 Pneumonia by Electrical Impedance Tomography: a Prospective Observational Study

**NCT ID:** [NCT04473300](https://clinicaltrials.gov/study/NCT04473300)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 43
- **Lead Sponsor:** Osaka University
- **Collaborators:** Hospital Rebagliati
- **Conditions:** Critical Illness, ARDS
- **Start Date:** 2020-05-11
- **Completion Date:** 2021-02-28
- **CT.gov Last Update:** 2021-07-01

## Brief Summary

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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients with positive SARS-CoV-2 infection＊
2. Patients with ARDS under mechanical ventilation＊＊
3. 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:

1. Contraindication for EIT monitoring

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

## Primary Outcomes

- **The distribution of ventilation** _(time frame: Through study completion (up to 24 hours))_ — The distribution of ventilation measured by EIT at PEEP 5 and 15.

## Secondary Outcomes

- **Silent spaces** _(time frame: Through study completion (up to 24 hours))_
- **Respiratory system compliance** _(time frame: Through study completion (up to 24 hours))_
- **Oxygenation** _(time frame: Through study completion (up to 24 hours))_
- **Dead space ventilation ratio** _(time frame: Through study completion (up to 24 hours))_

## Locations (1)

- Osaka University Hospital, Suita, Osaka, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.osaka university hospital|suita|osaka|japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04473300.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04473300*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*