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Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure (RCPBALSTAT)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Continuous control of Pcuff followed by manual control
Manual control of Pcuff followed by continuous control
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring tracheal cuff pressure, continuous control, microaspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ICU, Salengro Hospital, University Hospital of Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Continuous control of Pcuff followed by manual control

Manual control of Pcuff followed by continuous control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
October 16, 2013
Last Updated
March 23, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01965821
Brief Title
Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
Acronym
RCPBALSTAT
Official Title
Impact of Mallinckrodt Electronic Device on Continuous Control of Tracheal Cuff Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
tracheal cuff pressure, continuous control, microaspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous control of Pcuff followed by manual control
Arm Type
Other
Arm Description
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.
Arm Title
Manual control of Pcuff followed by continuous control
Arm Type
Other
Arm Description
Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)
Intervention Type
Device
Intervention Name(s)
Continuous control of Pcuff followed by manual control
Intervention Description
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
Intervention Name(s)
Manual control of Pcuff followed by continuous control
Intervention Description
24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device
Primary Outcome Measure Information:
Title
percentage of recording time spent with cuff overinflation or underinflation
Description
Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without Mallinckrodt device)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Impact of Mallinckrodt electronic device on microaspiration of gastric contents, documented by pepsin levels in tracheal aspirates
Description
Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without Mallinckrodt device)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad NSEIR, MD
Organizational Affiliation
University Hospital of Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU, Salengro Hospital, University Hospital of Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59035
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27704488
Citation
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.
Results Reference
derived

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

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