Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
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|ClinicalTrials.gov Identifier: NCT02109003|
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : June 2, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Cuff Overinflation Cuff Underinflation||Device: Pressure easy® device Device: Manual control of Pcuff followed by continuous control.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Continuous control of Pcuff followed by manual control
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.
Device: Pressure easy® device
Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.
Other Name: Pressure easy® device (Smiths medical cuff pressure controller)
Active Comparator: Manual control of Pcuff followed by continuous control.
Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)
Device: Manual control of Pcuff followed by continuous control.
Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.
- Percentage of recording time spent with cuff overinflation or underinflation [ Time Frame: 48 hours ]Continuous recording of cuff pressure will be performed during two 24-h periods (with or without Pressure easy® device)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
- Predicted duration of mechanical ventilation > or = 48h.
- Age > or = 18 years.
- Signed informed consent.
- Anticipated duration of mechanical ventilation<48h after randomization.
- Tracheostomized patients.
- Patients with contraindication for semirecumbent position.
- Patients participating to another trial that might influence this study results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109003
|Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Principal Investigator:||Andrey Rodriguez, MD||Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí|
|Responsible Party:||Antonio Artigas Raventós, Director of Critical Care Unit, Corporacion Parc Tauli|
|Other Study ID Numbers:||
|First Posted:||April 9, 2014 Key Record Dates|
|Last Update Posted:||June 2, 2015|
|Last Verified:||May 2015|