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

Completed

• Conditions: ARDS; Critical Illness

• Registration Number: NCT04473300
• Lead Sponsor: Osaka University

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.

Study Timeline

• Study Start: 2020-05-11
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-16
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Last Update Submitted: 2021-06-30
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distribution of ventilation	Through study completion (up to 24 hours)	The distribution of ventilation measured by EIT at PEEP 5 and 15.

Secondary Outcome Measures

Name	Time	Method
Silent spaces	Through study completion (up to 24 hours)	The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.
Respiratory system compliance	Through study completion (up to 24 hours)	Respiratory system compliance in PEEP 5 and 15.
Oxygenation	Through study completion (up to 24 hours)	Oxygenation in PEEP 5 and 15.
Dead space ventilation ratio	Through study completion (up to 24 hours)	Dead space ventilation ratio in PEEP 5 and 15.

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan