Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
NCT Number: NCT06848010
Randomized clinical trial in mechanically ventilate critically ill patients. The study will evaluated the efficacy of a continous endotracheal tube (ETT) cuff pressure controller (TRACH FLUSH group) compared to manual monitoring and inflation (STANDARD group).
Patients intubated, from at least 24 hours and with a predicted duration of invasive mechanical ventilation longer than 72 hours, will be randomized to the use of TRACH FLUSH versus nurse operated analogic cuff pressure controller q8.
Hypotesis of the study is the superiority of the continuous cuff pressure controller in maintaining cuff pressure within the target value, thus decreasing the incidence of microaspiration events.
Aim of the study are 1) to compare the incidence of cuff pressure value detection outside the target range between the TRACH FLUSH and the STANDARD group, and 2) to compare the incidence of sputum samples positive for (amylase and/or pepsin), a surrogate for tracheal micro-aspiration event.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Milan, 20122, Italy
Endotracheal intubation is an effective method of providing rapid and safe airway patency and respiratory support in the intensive care unit (ICU). Endotracheal intubation effectively isolates the trachea by inflating the endotracheal tube (ETT) cuff just below the vocal cords: this ensures airway patency and positive pressure ventilation. The pressure of the endotracheal tube cuff (Pcuff) should be between 20-30 cmH2O to ensure airway isolation. The literature reports that overinflation of the endotracheal cuff (>30 cmH2O) causes hoarseness, sore throat, inadequate swallowing of secretions, tracheal stenosis, tracheal wall damage, and ischemia due to decreased mucosal capillary blood flow: these changes can occur even if a high Pcuff is maintained for a short period of time. In contrast, inadequate inflation (less than 20 cmH2O) results in ventilation-associated pneumonia (VAP) due to ineffective ventilation and microaspiration of gastric and/or oropharyngeal secretions into the lungs. Risk factors for microaspiration include patient-related factors, factors related to endotracheal tube type, performance of invasive procedures such as enteral nutrition through a nasogastric or orogastric tube, and mechanical ventilation. Patient-related factors include supine position, sedation, coma, tracheal diameter, and viscosity of secretions, while among those related to tube type we find impossible vocal cord closure, longitudinal folds of low-pressure and high-volume polyvinyl chloride (PVC) tracheal tubes. The American Association of Critical-Care Nurses (AACN) states that in order to achieve adequate pressure and prevent mucosal damage, the amount of pressure and volume of air needed, the size, shape of the tube, mode of mechanical ventilation, and the patient's blood pressure must be taken into account.
The methods found in ICUs to control Pcuff and keep it within safe ranges are about a dozen and range from manual external palpation of the inflation balloon, to assessment of inspiratory/expiratory volume loss to continuous monitoring with appropriate instrumentation.
Despite the known Pcuff-related complications of ETT, there is a paucity of national or international guidelines on the optimal pressure value, frequency of pressure measurement, and measurement methods: however, some studies performed show that the use of an automated device that continuously monitors Pcuff significantly decreases gastric microaspirations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The automated endotracheal tube cuff pressure controller will continously assess and maintain the endotracheal tube cuff pressure at pre-specifed pressure level of 25 cmH20.
Time frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Incidence of measurements with a endotracheal cuff pressure outside the prespecified target value: 25 cmH2O
Time frame: From enrollment to either the 5th day of invasive mechanical ventilation, or discontinuation of invasive mechanical ventilation
Incidence of detection of detectable levels of Pepsin A and Amylase in the tracheal secretions samples. Daily sampling of tracheal secretions will be performed at 8:00AM.
Contact information is provided by the study sponsor or research team.
Policlinico Hospital
Other
Acronym: TRAC-PRES
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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