Safety and efficacy of MI-E for prevention of VAP

JRCT ID: jRCTs032190187

Registered date:15/01/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Critical ill patients
• Date of first enrollment: 15/01/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): MI-E

Outcome(s)

• Primary Outcome: Incidence 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 maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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.)

Related Information

• Primary Sponsor: Murata Atsushi
• Source(s) of Monetary Support: Chiba University Hospital