Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial
1 other identifier
interventional
270
2 countries
11
Brief Summary
Multicenter, cluster randomized, controlled, open-label trial to assess if AnapnoGuard System can minimize tracheal microaspiration and the risk of ventilator-associated pneumonia when compared to standard treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2022
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 3, 2022
CompletedStudy Start
First participant enrolled
June 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2024
CompletedMay 7, 2024
May 1, 2024
1.6 years
May 16, 2022
May 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Bacterial tracheobronchial colonization (number of events)
The proportion of patients with bacterial tracheobronchial colonization (\> 10\^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate
3 days
Other Outcomes (18)
Ventilator-associated pneumonia (number of events)
28 days
Microaspiration (number of events)
2 days
Ventilator-associated events (number of events)
28 days
- +15 more other outcomes
Study Arms (2)
AnapnoGuard group
EXPERIMENTALPatients intubated with AnapnoGuard endotracheal tube (polyvinylchloride tube with ellipsoidal shape, thin wall polyurethane cuff with dual suction lines and an extra venting line) which is connected to AnapnoGuard 100 System
Control group
ACTIVE COMPARATORPatients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Interventions
Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 control device. It includes an automatic high-sensitive subglottic capnograph which measures every few minutes the carbon dioxide level in the subglottic space. If the level of carbon dioxide is above the threshold (established by animal studies) the system will increase the cuff pressure by a formula, if the level is below the threshold, the system will decrease the cuff pressure by 1 mmHg. Variations of cuff pressure are allowed only between pressure limits set by the user (minimum and maximum)
ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O
Within 24 hours, AnapnoGuard tube will be connected to AnapnoGuard 100 device control which provides continuous subglottic secretion drainage (two different suction lines) and venting/rinsing (a third dedicated line)
Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen
Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture
Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase
Patients will be follow to detect clinical, radiological or microbiological signs of VAP. If suspected, a tracheal aspirate or a bronchoalveolar lavage is performed to confirm the diagnosis
Eligibility Criteria
You may qualify if:
- Primary intubation with the study ETT
- Expected duration of mechanical ventilation \>48 hours
- Age older than 18 years
You may not qualify if:
- Invasive mechanical ventilation in the last 14 days,
- Contraindication for enteral feeding
- Clinical evidence of inhalation before intubation
- Pregnancy
- Enrolling in another study that may interfere with this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Shamir Medical Center
Tel Aviv, Israel
Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"
Ancona, Italy
Azienda ospedaliera universitaria "Policlinico di Bari"
Bari, Italy
Humanitas Research Hospital
Milan, Italy
Azienda ospedaliera universitaria di Modena
Modena, Italy
Azienda ospedaliera Federico II
Napoli, Italy
Azienda ospedaliera universitaria "Luigi Vanvitelli"
Napoli, Italy
Policlinico "P. Giaccone"
Palermo, Italy
Azienda ospedaliera Perugia
Perugia, Italy
Fondazione Policlinico "A. GEMELLI"
Roma, 00168, Italy
Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette
Torino, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gennaro De Pascale, MD
Fondazione Policlinico A. Gemelli IRCCS
- STUDY CHAIR
Massimo Antonelli, MD
Fondazione Policlinico A. Gemelli IRCCS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
June 3, 2022
Study Start
June 6, 2022
Primary Completion
January 9, 2024
Study Completion
April 9, 2024
Last Updated
May 7, 2024
Record last verified: 2024-05