Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

Critical Illness Clinical Trial

— RCPBALSTAT  

Official title:

Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965821
• Other study ID #: 2012_41
• Secondary ID: 2013 A00225 40
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: March 23, 2017
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2017
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflations and overinflations 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 Mallinckrodt electronic device (Mallinckrodt electronic cuff pressure controller, VBM Medizintechnik GmbH, Sulz aN) in continuous control of tracheal cuff pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: :

• Patients intubated in the ICU with a high volume / low pressure PVC-cuffed tracheal tube

• Predicted duration of mechanical ventilation > or = 48h

• Age > or = 18 years

• signed informed consent

Exclusion Criteria:

• Contraindication for semirecumbent position

• Contraindication for enteral nutrition

• Pregnancy

• refuse to participate to the study

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Continuous control of Pcuff followed by manual control
continuous control of tracheal cuff pressure using an electronic device for 24 h followed by manual control of cuff pressure using a manometer
• Manual control of Pcuff followed by continuous control
24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device

Locations

Country	Name	City	State
France	ICU, Salengro Hospital, University Hospital of Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of recording time spent with cuff overinflation or underinflation	Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)	48 hours
Secondary	Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates	Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)	48 hours