Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device (Nosten)
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ClinicalTrials.gov Identifier: NCT01351259 |
Recruitment Status
:
Completed
First Posted
: May 10, 2011
Last Update Posted
: September 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mechanical Ventilation Complication Tracheal Intubation Morbidity | Device: Pneumatic device, cylindrical or tapered cuff | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Pneumatic device, tapered cuff
Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff
|
Device: Pneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Other Names:
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Experimental: Pneumatic device, cylindrical cuff
Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes
|
Device: Pneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Other Names:
|
Active Comparator: Routine care, tapered cuff
Routine care of cuff pressure using a manometer, tapered polyurethane cuff
|
Device: Pneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Other Names:
|
Active Comparator: Routine care, cylindrical cuff
Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff
|
Device: Pneumatic device, cylindrical or tapered cuff
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
Other Names:
|
- Percentage of patients with underinflation or overinflation of cuff pressure [ Time Frame: 48 h ]Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)
- Impact of tracheal-cuff shape on variations in cuff pressure [ Time Frame: 48 h ]Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.
- Impact of continuous control of cuff pressure on microaspiration of gastric contents [ Time Frame: 48 h ]Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device)
- Impact of tracheal cuff shape on microaspiration of gastric contents [ Time Frame: 48 h ]Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients requiring intubation in the ICU
- Predicted duration of mechanical ventilation > or = 48h
- Age > or = 18 years
Exclusion Criteria:
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy

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): NCT01351259
France | |
ICU, Calmette Hospital, CHU de Lille | |
Lille, Nord, France, 59037 |
Principal Investigator: | Saad NSEIR, MD | CHU de Lille |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Saad NSEIR, Dr, University Hospital, Lille |
ClinicalTrials.gov Identifier: | NCT01351259 History of Changes |
Other Study ID Numbers: |
2009-A00598-49 2009_20/0925 ( Other Identifier: sponsor ) |
First Posted: | May 10, 2011 Key Record Dates |
Last Update Posted: | September 4, 2013 |
Last Verified: | August 2013 |
Keywords provided by Saad NSEIR, University Hospital, Lille:
Mechanical ventilation Intubation Cuff pressure Microaspiration |