Safety and efficacy of MI-E for prevention of VAP

Phase 2

Recruiting

• Conditions: Critical ill patients

• Registration Number: JPRN-jRCTs032190187
• Lead Sponsor: Murata Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of VAP (defined as ATS)

Secondary Outcome Measures

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