Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia
NCT ID: NCT05403320
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2022-06-06
2024-04-09
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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AnapnoGuard group
Patients 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
Continuous cuff pressure regulation
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)
Automatic subglottic secretion drainage
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)
Tracheobronchial colonization assessment
Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture
Microaspiration assessment
Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase
VAP assessment
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
Control group
Patients intubated with TaperGuard Evac endotracheal tube (polyvinylchloride conic cuff with additional lumen for subglottic secretion suctioning)
Intermittent cuff pressure regulation
ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O
Manual subglottic secretion drainage
Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen
Tracheobronchial colonization assessment
Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture
Microaspiration assessment
Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase
VAP assessment
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
Interventions
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Continuous cuff pressure regulation
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)
Intermittent cuff pressure regulation
ET cuff pressure will be manually measured three times per day using a portable manometer, and kept constant within 20-30 cmH2O
Automatic subglottic secretion drainage
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)
Manual subglottic secretion drainage
Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen
Tracheobronchial colonization assessment
Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture
Microaspiration assessment
Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase
VAP assessment
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
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Inclusion Criteria
* Expected duration of mechanical ventilation \>48 hours
* Age older than 18 years
Exclusion Criteria
* Contraindication for enteral feeding
* Clinical evidence of inhalation before intubation
* Pregnancy
* Enrolling in another study that may interfere with this trial
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Gennaro De Pascale, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD
Role: STUDY_CHAIR
Fondazione Policlinico A. Gemelli IRCCS
Locations
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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, , Italy
Azienda ospedaliera universitaria Città della Salute e della Scienza di Torino - presidio Molinette
Torino, , Italy
Countries
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Other Identifiers
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4739
Identifier Type: -
Identifier Source: org_study_id
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