NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032190187

Registered date:15/01/2020

Safety and efficacy of MI-E for prevention of VAP

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCritical ill patients
Date of first enrollment15/01/2020
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)MI-E

Outcome(s)

Primary OutcomeIncidence of VAP (defined as ATS)
Secondary Outcome[Efficacy] 1)Numbers of bronchoscopies/mechanical ventilation (MV) duration 2)Numbers of bronchial obstructions defined as an oxyhaemoglobin saturation < 90%/MV duration 3)Numbers of days with antibiotic use/MV duration 4)MV duration 5)Length of ICU stay 6)Duration of MV weaning to discharge 7)Mortality [Safety] Frequency of adverse events [Exploratory] 1)Maximum pressure of MI-E setting (insufflation/exsufflation) 2)Maximum cough peak flow (MI-E monitor) 3) Cough peak expiratory flow (MV monitor)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1)Patients older than 18 years 2)Under invasive mechanical ventilation for more than 48 hours in ICU 3)Administration of rehabilitation including CPT 4) Patients with written consent after receiving sufficient explanation for this study. The consent is based on free will
Exclude criteria1)Pneumothorax, pneumomediastinum, pulmonary bullae more than 1 cm 2)Severe cardiovascular failure defined as NYHA class III or IV 3)Active alveolar haemorrhage 4)Pneumonia provision of mechanical ventilation for less than 48 hours 5)Injury or complication that did not allow CPT to be provided 6) Patients who are judged to be at risk of patient safety in the study or that it is difficult to comply with the protocol (eg consider ventilator settings etc.)

Related Information

Contact

Public contact
Name Ryota Kuroiwa
Address 1-8-1 Inohana, Chuo-Ku, Chiba-City, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail pseudoarthrosis7@chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Atsushi Murata
Address 1-8-1 Inohana, Chuo-Ku, Chiba-City, Chiba Chiba Japan 260-8677
Telephone +81-43-222-7171
E-mail atsushi_murata@faculty.chiba-u.jp
Affiliation Chiba University Hospital