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Completed

NCT Number: NCT01965821

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, 59035, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous control of Pcuff followed by manual control

Device

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

Device

24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device

Primary outcomes

  1. percentage of recording time spent with cuff overinflation or underinflation

    Time frame: 48 hours

    Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)

Secondary outcomes

  1. Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates

    Time frame: 48 hours

    Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: RCPBALSTAT

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2013
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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