Critical IllnessRCPBALSTATNCT01965821
Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
A study of Critical Illness, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
- refuse to participate to the study
Trial locations and contacts
1 site in 1 country.
France1 site
ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, 59035
About this study
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
- Being tested
- Continuous control of Pcuff followed by manual control, Manual control of Pcuff followed by continuous control
- Keywords
- tracheal cuff pressure, continuous control, microaspiration
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous control of Pcuff followed by manual controlDevice
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 controlDevice
24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device
| Study group | Role | What they receive |
|---|---|---|
| Continuous control of Pcuff followed by manual control | Other | 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. Receives: Device: Continuous control of Pcuff followed by manual control |
| Manual control of Pcuff followed by continuous control | Other | Patients receive the reverse sequence (manual control followed by continuous control of Pcuff) Receives: Device: Manual control of Pcuff followed by continuous control |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of recording time spent with cuff overinflation or underinflation
Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)
Measured: 48 hours
Secondary outcomes (1)
Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates
Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad NSEIR, MD, Principal investigator, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965821
- Sponsor's protocol ID
- 2012_41
- Other IDs
- 2013 A00225 40
- Acronym
- RCPBALSTAT
- Status last verified
- Mar 2017
- First submitted
- 16 Oct 2013
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27704488
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
- ClinicalTrials.gov ID
- NCT01965821
- Acronym / sponsor ID
- RCPBALSTAT / 2012_41
- Conditions
- Critical Illness
- Keywords
- tracheal cuff pressure, continuous control, microaspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous control of Pcuff followed by manual control | Other | Device: Continuous control of Pcuff followed by manual controlPatients 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. |
| Manual control of Pcuff followed by continuous control | Other | Device: Manual control of Pcuff followed by continuous controlPatients receive the reverse sequence (manual control followed by continuous control of Pcuff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
- refuse to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous control of Pcuff followed by manual controlcontinuous control of tracheal cuff pressure using an electronic device for 24 h followed by manual control of cuff pressure using a manometer | Device | Continuous control of Pcuff followed by manual control |
| Manual control of Pcuff followed by continuous control24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device | Device | Manual control of Pcuff followed by continuous control |
Primary outcome
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)
1 secondary outcome
Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 27704488Rouze 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad NSEIR, MD principal investigator
University Hospital of Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Critical Illness, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of recording time spent with cuff overinflation or underinflation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01965821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.