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Completed

NCT Number: NCT05403320

Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

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

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shamir Medical Center, Tel Aviv, Israel

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous cuff pressure regulation

Device

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

Device

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

Device

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

Device

Subglottic secretions will be manually drained with a 10 mL syringe, using the only dedicated lumen

Tracheobronchial colonization assessment

Diagnostic Test

Tracheal aspirate will be performed after intubation and after 72 hours for microbiological colture

Microaspiration assessment

Diagnostic Test

Tracheal aspirates will be performed 72 hours after intubation, and collected in a predefined study center to measure pepsin and salivary amylase

VAP assessment

Diagnostic Test

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

Primary outcomes

  1. Bacterial tracheobronchial colonization (number of events)

    Time frame: 3 days

    The proportion of patients with bacterial tracheobronchial colonization (> 10^3 CFU/mL) on Day 3 after randomization, measured from tracheal aspirate

Other outcomes

  1. Ventilator-associated pneumonia (number of events)

    Time frame: 28 days

    The proportion of patients who develop ventilator-associated pneumonia (presence of radiological and clinical signs consisting of a new and persistent infiltrate on the chest radiograph associated with two of the three following criteria: purulent tracheal aspirates, hyperthermia >38 °C or hypothermia <36 °C and peripheral leucocytosis >10,000/μ l or <1,500/μ. A microbiological confirmation is required using tracheal aspirate ≥ 10^5 CFU/ml or bronchoalveolar lavage ≥ 10^4 CFU/ml)

  2. Microaspiration (number of events)

    Time frame: 2 days

    The prevalence of patients with gastric and oropharyngeal microaspiration or abundant microaspiration (Microaspiration is defined by the presence of alpha-amylase >1685 UI/L in tracheal aspirates. Abundant microaspiration is defined by pepsin level >200 ng/mL in >30 % of tracheal aspirates during the 48 h following inclusion.)

  3. Ventilator-associated events (number of events)

    Time frame: 28 days

    The proportion of patients who develop ventilator-associated events, defined as a sustained increase in ventilator support (minimum PEP increase >2.5 cm H2 O, or minimum FiO2 increase >15 %) after >2 days of stable or decrease settings

  4. Time to ventilator-associated pneumonia (days)

    Time frame: 28 days

    The time until the first diagnosis of ventilator-associated pneumonia is established

  5. Antibiotic-free days (days)

    Time frame: 28 days

    The number of days in which the patient is not treated with any antibiotic drug

  6. Ventilator-free days (days)

    Time frame: 28 days

    The number of days in which patients do not receive mechanical ventilation within 28 days from randomization

  7. Length of intensive care unit stay (days)

    Time frame: 28 days

    The number of days in which the patient is admitted in intensive care unit or in hospital

  8. Length of hospital stay (days)

    Time frame: 28 days

    The number of days in which the patient is admitted in hospital

  9. In-intensive care unit mortality (number of events)

    Time frame: 28 days

    All-cause mortality, assessed at the discharge from the intensive care unit

  10. In-hospital mortality (number of events)

    Time frame: 28 days

    All-cause mortality, assessed at the discharge from the hospital

  11. 28-day mortality (number of events)

    Time frame: 28 days

    All-cause 28-day mortality

  12. 60-day mortality (number of events)

    Time frame: 60 days

    All-cause 60-day mortality

  13. 90-day mortality (number of events)

    Time frame: 90 days

    All-cause 90-day mortality

  14. Tracheobronchial colonization count (number of events)

    Time frame: 3 days

    The proportion of tracheal aspirates with colonization count >10^4, 10^5, 10^6, >= 10^7 CFU/mL

  15. Post-extubation stridor (number of events)

    Time frame: 1 day

    The proportion of patients who experience stridor after extubation

  16. Total subglottic secretion volume

    Time frame: 28 days

    The amount of secretions which has been drained from subglottic space during the enrolment

  17. Daily subglottic secretion volume

    Time frame: 1 day

    Daily amount of secretions which has been drained from subglottic space

  18. Out of range cuff pressure

    Time frame: 28 days

    The proportion of cuff pressure values whose are out of the safety limits

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Official study title

An Innovative Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia. A Multicenter Cluster-Randomized Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2022
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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