MedDataX Logo

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

NCT ID: NCT01965821

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

tracheal cuff pressure continuous control microaspiration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Continuous control of Pcuff followed by manual control

Intervention Type 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

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

Group Type OTHER

Manual control of Pcuff followed by continuous control

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Saad NSEIR, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Rouze A, De Jonckheere J, Zerimech F, Labreuche J, Parmentier-Decrucq E, Voisin B, Jaillette E, Maboudou P, Balduyck M, Nseir S. Efficiency of an electronic device in controlling tracheal cuff pressure in critically ill patients: a randomized controlled crossover study. Ann Intensive Care. 2016 Dec;6(1):93. doi: 10.1186/s13613-016-0200-2. Epub 2016 Oct 4.

Reference Type RESULT
PMID: 27704488 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013 A00225 40

Identifier Type: OTHER

Identifier Source: secondary_id

2012_41

Identifier Type: -

Identifier Source: org_study_id