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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01965821

Acronym

RCPBALSTAT

Enrollment

Registered

2013-10-18

Start date

2013-10-31

Completion date

2014-12-31

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

tracheal cuff pressure, continuous control, microaspiration

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.

Interventions

DEVICEContinuous 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

DEVICEManual 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026