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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473300
• Other study ID #: ASPEIT
• Status: Completed
• Start date: May 11, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: July 2020
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• Critical Illness
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Hospital Rebagliati

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distribution of ventilation	The distribution of ventilation measured by EIT at PEEP 5 and 15.	Through study completion (up to 24 hours)
Secondary	Silent spaces	The changes in dependent and non-dependent silent spaces measured by EIT in PEEP 5 and 15.	Through study completion (up to 24 hours)
Secondary	Respiratory system compliance	Respiratory system compliance in PEEP 5 and 15.	Through study completion (up to 24 hours)
Secondary	Oxygenation	Oxygenation in PEEP 5 and 15.	Through study completion (up to 24 hours)
Secondary	Dead space ventilation ratio	Dead space ventilation ratio in PEEP 5 and 15.	Through study completion (up to 24 hours)