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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Continuous control of Pcuff followed by manual control; Device: Manual control of Pcuff followed by continuous control

• Registration Number: NCT01965821
• Lead Sponsor: University Hospital, Lille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-18
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous control of Pcuff followed by manual control	Continuous control of Pcuff followed by manual control	Patients receive continuous control of cuff pressure with Mallinckrodt electronic device for 24h, followed by discontinuous control (every 8 hours) with a manual manometer for 24h.
Manual control of Pcuff followed by continuous control	Manual control of Pcuff followed by continuous control	Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)

Primary Outcome Measures

Name	Time	Method
percentage of recording time spent with cuff overinflation or underinflation	48 hours	Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)

Secondary Outcome Measures

Name	Time	Method
Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates	48 hours	Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)

Trial Locations

Locations (1)

ICU, Salengro Hospital, University Hospital of Lille; 🇫🇷 Lille, Nord, France