Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure (RCPBALSTAT)

University Hospital, Lille

Status: Completed

Conditions: Critical Illness

Treatments: Device: Manual control of Pcuff followed by continuous control; Device: Continuous control of Pcuff followed by manual control

Study type: Interventional

Funder types: Other

Identifiers

NCT01965821

2012_41

2013 A00225 40 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Continuous control of Pcuff followed by manual control

Other group

Description:

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.

Treatment:

Device: Continuous control of Pcuff followed by manual control

Manual control of Pcuff followed by continuous control

Other group

Description:

Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)

Treatment:

Device: Manual control of Pcuff followed by continuous control