NCT01965821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 22, 2025

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

October 16, 2013

Last Update Submit

December 15, 2025

Conditions

Critical Illness

Keywords

tracheal cuff pressurecontinuous controlmicroaspiration

Outcome Measures

Primary Outcomes (1)

  • 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)

    48 hours

Secondary Outcomes (1)

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

    48 hours

Study Arms (2)

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.

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)

Device: Manual control of Pcuff followed by continuous control

Interventions

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

Continuous control of Pcuff followed by manual control
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

Manual control of Pcuff followed by continuous control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication for semirecumbent position
  • Contraindication for enteral nutrition
  • Pregnancy
  • refuse to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Salengro Hospital, University Hospital of Lille

Lille, Nord, 59035, France

Location

Related Publications (1)

  • 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.

    PMID: 27704488RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saad NSEIR, MD

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 22, 2025

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)