Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.
The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) in continuous control of tracheal cuff pressure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous control of Pcuff followed by manual control | Experimental | Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h. |
|
| Manual control of Pcuff followed by continuous control. | Active Comparator | Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure easy® device | Device | Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of recording time spent with cuff overinflation or underinflation | Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device) | 48 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrey Rodriguez, MD | Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26059205 | Derived | Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Manual control of Pcuff followed by continuous control. | Device | Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device. |
|