Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473300
Other study ID # ASPEIT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness