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Safety and efficacy of Mechanical in-exsufflation for prevention of ventilator-associated pneumonia in an intensive care unit: A single center clinical trial

Safety and efficacy of MI-E for prevention of VAP

Murata Atsushi

Chiba University Hospital

1-8-1 Inohana, Chuo-Ku, Chiba-City, Chiba

atsushi_murata@faculty.chiba-u.jp

Kuroiwa Ryota

Chiba University Hospital

1-8-1 Inohana, Chuo-Ku, Chiba-City, Chiba

+81-43-222-7171

pseudoarthrosis7@chiba-u.jp

Recruiting

Jan. 15, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) 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

1) 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.)

Both

Critical ill patients

MI-E

Incidence of VAP (defined as ATS)

[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)

+81-43-226-2616

No

none