COVID-19 infectious disease, diseases requiring respiratory ventilation such as respiratory failure
Conditions
Interventions
Using an unapproved ventilator for humans
Sponsors
Wakabayashi Kenji
Metran co.Ltd
Metran Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older entering the Tokyo Medical and Dental University Intensive Care Unit 2) Patients on or scheduled to undergo mechanical ventilation with tracheal intubation or tracheostomy 3) Patients who, after receiving a sufficient explanation before participating in this study, have a thorough understanding and have the free written consent of the patient himself / herself.(Delegate if not possible)
Exclusion criteria
Exclusion criteria: 1) Patients needing high ventilation settings (PEEP> 10, PIP> 25, FIO2> 0.6) 2) Patients with unstable hemodynamics 3) Patients requiring strict adjustment of ventilation such as hypertension and pulmonary hypertension 4) Patients who have already suffered pressure injury such as pneumothorax and longitudinal emphysema 5) Patients who are judged to be unsuitable for research by the research doctors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Stable usage rate 24 hours after the start of use; proportion of patients who cannot continue stable artificial respiration due to equipment replacement, equipment removal, and other equipment problems (2) Ventilation success rate: Proportion of patients who survived spontaneous breathing due to respiratory withdrawal | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Changes in respiratory settings before and after using research equipment (2) Changes in ventilation, oxygenation, and ventilation before and after using research equipment (3) Circuit pressure and inspiratory expiratory flow rate pattern while using research equipment (4) Actual measurement of fresh gas FiO2 (5) Presence or absence of adverse events / deficiencies related to artificial respiration management (hypoxemia, hypercapnia, pneumothorax, operation mistakes, equipment troubles, etc.) (6) Number of days the ventilator is used (7) Number of hospitalization days (8) Mortality (9) Respiratory withdrawal rate (10) Development of ventilator-related pneumonia (11) Onset of other adverse events and complications (12) Changes in sedation (RASS) and vital signs (13) Catecholamine dosage (14) Volume of infusion (15) Number of suctions, sedative required amount (16) Questionnaire about operability for medical personnel engaged in this research | — |
Contacts
Public ContactKenji Wakabayashi
Tokyo Medical and Dental University Medical Hospital
Outcome results
None listed