Combined Strategy Using Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring to Prevent Microaspiration: a Multicenter Randomized Controlled Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined strategy, Automated subglottic secretion drainage, Automated continuous cuff pressure monitoring, Control group.
- Who it may be relevant to
- Registry conditions: Pneumonia, Ventilator-Associated Healthcare-associated Pneumonia Respiration, Artificial. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combined Strategy to Prevent Microaspiration (CoSMic): Impact of the Combination of Automated Subglottic Secretion Drainage and Continuous Cuff Pressure Monitoring on the Incidence of Abundant Microaspiration of Gastric or Oropharyngeal Secretions in Mechanically Ventilated Critically Ill Patents: a Multicenter Randomized Controlled Trial.
Overview
This trial will study the impact of a combined strategy to prevent microaspiration of oropharyngeal secretions or gastric content using automated subglottic secretion drainage and/or continuous cuff pressure monitoring. These measures aim at preventing secretions of oropharyngeal or gastric origin from entering lower respiratory tracts of patients under invasive mechanical ventilation in intensive care units (ICU), referred to as microaspiration, in the hope of preventing ventilator-associated pneumonia, a condition associated with patient outcome worsening. Patients will be randomly assigned to one of four groups: a combined strategy group using both automated techniques, 2 groups using either one or the other automated technique, and a control group using standard of care. Microaspiration will be detected by measuring concentration of oropharyngeal (amylase) or gastric (pepsin) enzymes in tracheal aspirates.
Detailed description
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually.
Interventions
- Procedure Combined strategy
Subglottic secretion drainage and cuff pressure monitoring will be performed using automated bedside devices - Procedure Automated subglottic secretion drainage
Subglottic secretion drainage will be performed using an automated bedside device. Cuff pressure will be monitored manually. - Procedure Automated continuous cuff pressure monitoring
Tracheal cuff pressure will be monitored continuously using an automated bedside device. Subglottic secretion drainage will be performed manually - Procedure Control group
Both tracheal cuff pressure monitoring and subglottic secretion drainage will be performed manually and discontinuously
Primary outcome measures
- Frequency of global abundant microaspiration [Time frame: 48 hours after inclusion]
Secondary outcome measures (4)
- Ventilator-associated pneumonia incidence [Time frame: 28 days]
- Duration of mechanical ventilation [Time frame: 28 days]
- ICU length of stay [Time frame: 28 days]
- Mortality [Time frame: 28 days]
Eligibility criteria
Inclusion criteria
Adult patients (> 18 years-old) admitted to the ICU Mechanical ventilation duration expected to be > 48 h Intubated with a tracheal tube allowing subglottic secretion drainage
Exclusion criteria
Ongoing pregnancy Patients lacking health insurance Patients lacking legal capacity Moribund patients (expected to die in the first 24 h of ICU stay) Patients with specific oropharyngeal conditions (e.g. severe soft tissue infections of the neck, pharyngeal or laryngeal surgery, history of larynx or pharynx irratidation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07555236 · 2023_0735 · ID RCB