Safety and efficacy of MI-E for prevention of VAP

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032190187

Enrollment

Registered

2020-01-15

Start date

2020-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical ill patients

Interventions

MI-E

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.)

Design outcomes

Primary

Measure	Time frame
Incidence of VAP (defined as ATS)	—

Secondary

Measure	Time frame
[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)	—

Measure

Time frame

[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)

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Contacts

Public ContactRyota Kuroiwa

Chiba University Hospital

pseudoarthrosis7@chiba-u.jp+81-43-222-7171

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026