Clinical trial NCT05403320: Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
Official title: An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2022-06-03
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter cluster randomized controlled and open-label trial. Because intubation is an urgent intervention in critically ill patients patients with acute respiratory failure, individual randomization is considered too complex and we predetermined cluster of 9 consecutive patients, stratified by centers, with each cluster being assigned to one of the study groups.
Primary purpose: PREVENTION

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

Detailed description: Maintaining the endotracheal tube (ETT) cuff appropriately inflated plays a crucial role in the management of intubated patients because overinflation may cause tracheal wall damage, ulcerations and stenosis, and underinflation may results in fluid leakage and ventilator-associated pneumonia (VAP).

During mechanical ventilation, secretions contaminated with oropharyngeal and gastric pathogens pool in the subglottic space (tracheal region between the ETT cuff and the vocal cords) and enter the lower airways via microaspiration.

Subglottic secretion drainage (SSD) reduces the incidence of VAP and can be performed intermittently or continuously, with varying efficacy and often causing secondary tracheal mucosa lesions.

AnapnoGuard (AG) ETT has three dedicated lines (two suction lines and one sensing/venting/rinsing line) and can be connected to the AG 100 System, a new device which provides high-sensitive capnography of subglottic space and consequent adjustment of cuff pressure, to avoid fluid leakage and overinflation. It also evacuates secretions from the subglottic space by simultaneously rinsing/venting this space using the ETT dedicated line.

The hypothesis is that AG System may reduce the incidence of microaspiration, bacterial tracheal colonization and consequently the risk of VAP when compared to standard treatment (ETT with manually performed secretion drainage and cuff pressure control).

Eligibility criteria: Inclusion Criteria:

* Primary intubation with the study ETT
* Expected duration of mechanical ventilation \>48 hours
* Age older than 18 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bacterial tracheobronchial colonization (number of events)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
measure: Ventilator-associated pneumonia (number of events)
timeFrame: 28 days
measure: Microaspiration (number of events)
timeFrame: 2 days
measure: Ventilator-associated events (number of events)
timeFrame: 28 days
measure: Time to ventilator-associated pneumonia (days)
timeFrame: 28 days
measure: Antibiotic-free days (days)
timeFrame: 28 days
measure: Ventilator-free days (days)
timeFrame: 28 days
measure: Length of intensive care unit stay (days)
timeFrame: 28 days
measure: Length of hospital stay (days)
timeFrame: 28 days
measure: In-intensive care unit mortality (number of events)
timeFrame: 28 days
measure: In-hospital mortality (number of events)
timeFrame: 28 days
measure: 28-day mortality (number of events)
timeFrame: 28 days
measure: 60-day mortality (number of events)
timeFrame: 60 days
measure: 90-day mortality (number of events)
timeFrame: 90 days
measure: Tracheobronchial colonization count (number of events)
timeFrame: 3 days
measure: Post-extubation stridor (number of events)
timeFrame: 1 day
measure: Total subglottic secretion volume
timeFrame: 28 days
measure: Daily subglottic secretion volume
timeFrame: 1 day
measure: Out of range cuff pressure
timeFrame: 28 days
Locations:
city: Tel Aviv
country: Israel
facility: Shamir Medical Center
city: Ancona
country: Italy
facility: Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"
city: Bari
country: Italy
facility: Azienda ospedaliera universitaria "Policlinico di Bari"
city: Milano
country: Italy
facility: Humanitas Research Hospital
city: Modena
country: Italy
facility: Azienda ospedaliera universitaria di Modena
city: Napoli
country: Italy
facility: Azienda ospedaliera Federico II
city: Napoli
country: Italy
facility: Azienda ospedaliera universitaria "Luigi Vanvitelli"
city: Palerme
country: Italy
facility: Policlinico "P. Giaccone"
city: Perugia
country: Italy
facility: Azienda ospedaliera Perugia
city: Roma
country: Italy
facility: Fondazione Policlinico "A. GEMELLI"
city: Torino
country: Italy
facility: Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Gennaro De Pascale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Massimo Antonelli, MD
role: STUDY_CHAIR
References: