Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410664
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-02
Brief Title:
Efficiency and Safety of the Prolonged Use of Heat and Moisture Exchangers in ICU
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
Safety and Efficiency of the Prolonged 72-hour Use of a Single Heat and Moisture Exchanger in Adult Mechanically Ventilated Critically Ill and Its Impact on the Lower Respiratory Tract Pathogenic Microbial Colonisation Rate FILTRex Trial a Single-centre Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FILTRex
Brief Summary:
FILTRex is a single-centre controlled randomised prospective non-inferiority clinical trial to compare the efficiency and safety of prolonged 72-hours versus standard 24-hours duration of use for Heat and Moisture Exchange HME filters in adult mechanically ventilated critically ill patients
Detailed Description:
Rationale Ventilator-associated pneumonia VAP is the most common hospital-acquired infection HAI in the intensive care unit ICU and its impact is very high in terms of morbidity length of hospital stay and overall costs Minimising manipulation and disconnection of the ventilator circuit by reducing the frequency of HME filter exchange may lower the risk of its secondary contamination hence the incidence of VAP while maintaining its efficacy in terms of sufficient humidification of the inhaled gas mixture and safety in terms of no or minimal change in resistance to airflow
Aim To test the effectiveness and safety of prolonged 72-hour exchange interval use of a single HME
Design Prospective single-centre parallel-group randomised controlled trial Subjects ICU patients general ICU
Treatment in the intervention group HME filter exchange every 72 hours
Control group Standard-of-care daily HME filter exchange
Primary outcome
1 Presence of HME-associated adverse events a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia
2 The cumulative incidence of lower respiratory tract microbial colonisation analysed by the Kaplan-Maier method censored in the case of ICU discharge or extubation 24h
Secondary and exploratory outcomes Differences in the relative risk of infection-related ventilator-associated complications antibiotics ATB exposure analysis length of ICU stay in days time frame three months number of ventilator-free days time frame 28 days differences in the incidence of endotracheal tube occlusion necessitating reintubation between individual groups differences in airway resistance humidity delivered to the patients and efficacy of HMEs between groups
Aim To test the effectiveness and safety of prolonged 72-hour exchange interval use of a single HME
Design Prospective single-centre parallel-group randomised controlled trial Subjects ICU patients general ICU
Treatment in the intervention group HME filter exchange every 72 hours
Control group Standard-of-care daily HME filter exchange
Primary outcome
1 Presence of HME-associated adverse events a composite endpoint of endotracheal tube occlusion or nosocomial tracheobronchitis or pneumonia
2 The cumulative incidence of lower respiratory tract microbial colonisation analysed by the Kaplan-Maier method censored in the case of ICU discharge or extubation 24h
Secondary and exploratory outcomes Differences in the relative risk of infection-related ventilator-associated complications antibiotics ATB exposure analysis length of ICU stay in days time frame three months number of ventilator-free days time frame 28 days differences in the incidence of endotracheal tube occlusion necessitating reintubation between individual groups differences in airway resistance humidity delivered to the patients and efficacy of HMEs between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None