Cuff Pressure Control and Evacuation of Subglottic Secretions To Prevent Pneumonia

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403320
• Other study ID #: 4739
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: April 9, 2024

Study information

• Verified date: May 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: April 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• 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

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Israel	Shamir Medical Center	Tel Aviv
Italy	Azienda ospedaliera universitaria "Ospedali riuniti di Ancona"	Ancona
Italy	Azienda ospedaliera universitaria "Policlinico di Bari"	Bari
Italy	Humanitas Research Hospital	Milano
Italy	Azienda ospedaliera universitaria di Modena	Modena
Italy	Azienda ospedaliera Federico II	Napoli
Italy	Azienda ospedaliera universitaria "Luigi Vanvitelli"	Napoli
Italy	Policlinico "P. Giaccone"	Palerme
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

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Catholic University of the Sacred Heart

Countries where clinical trial is conducted

Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ventilator-associated pneumonia (number of events)	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)	28 days
Other	Microaspiration (number of events)	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.)	2 days
Other	Ventilator-associated events (number of events)	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	28 days
Other	Time to ventilator-associated pneumonia (days)	The time until the first diagnosis of ventilator-associated pneumonia is established	28 days
Other	Antibiotic-free days (days)	The number of days in which the patient is not treated with any antibiotic drug	28 days
Other	Ventilator-free days (days)	The number of days in which patients do not receive mechanical ventilation within 28 days from randomization	28 days
Other	Length of intensive care unit stay (days)	The number of days in which the patient is admitted in intensive care unit or in hospital	28 days
Other	Length of hospital stay (days)	The number of days in which the patient is admitted in hospital	28 days
Other	In-intensive care unit mortality (number of events)	All-cause mortality, assessed at the discharge from the intensive care unit	28 days
Other	In-hospital mortality (number of events)	All-cause mortality, assessed at the discharge from the hospital	28 days
Other	28-day mortality (number of events)	All-cause 28-day mortality	28 days
Other	60-day mortality (number of events)	All-cause 60-day mortality	60 days
Other	90-day mortality (number of events)	All-cause 90-day mortality	90 days
Other	Tracheobronchial colonization count (number of events)	The proportion of tracheal aspirates with colonization count >10^4, 10^5, 10^6, >= 10^7 CFU/mL	3 days
Other	Post-extubation stridor (number of events)	The proportion of patients who experience stridor after extubation	1 day
Other	Total subglottic secretion volume	The amount of secretions which has been drained from subglottic space during the enrolment	28 days
Other	Daily subglottic secretion volume	Daily amount of secretions which has been drained from subglottic space	1 day
Other	Out of range cuff pressure	The proportion of cuff pressure values whose are out of the safety limits	28 days
Primary	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