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

NCT01965821 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

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

DEVICE

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

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Saad NSEIR, MD · University Hospital of Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01965821 on ClinicalTrials.gov