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Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

Primary Purpose

Cuff Overinflation, Cuff Underinflation

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pressure easy® device
Manual control of Pcuff followed by continuous control.
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cuff Overinflation focused on measuring tracheal cuff, cuff overinflation, cuff underinflation

Eligibility Criteria

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

Inclusion Criteria:

  • Patients intubated in the ICU with a polyvinyl chloride (PVC) cuffed tracheal tube.
  • Predicted duration of mechanical ventilation > or = 48h.
  • Age > or = 18 years.
  • Signed informed consent.

Exclusion Criteria:

  • Anticipated duration of mechanical ventilation<48h after randomization.
  • Tracheostomized patients.
  • Patients with contraindication for semirecumbent position.
  • Patients participating to another trial that might influence this study results.

Sites / Locations

  • Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

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 Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h.

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 two 24-h periods (with or without Pressure easy® device)

Secondary Outcome Measures

Full Information

First Posted
April 7, 2014
Last Updated
May 30, 2015
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT02109003
Brief Title
Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Official Title
Efficiency of PressureEasy in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite intermittent control of tracheal cuff pressure using a manual manometer, cuff underinflation and overinflation frequently occur in critically ill patients, resulting in increased risk for microaspiration and tracheal ischemic lesions.
Detailed Description
The aim of this study is to determine the efficiency of Pressure easy® device (Smiths medical cuff pressure controller) 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
Cuff Overinflation, Cuff Underinflation
Keywords
tracheal cuff, cuff overinflation, cuff underinflation

7. Study Design

Primary Purpose
Prevention
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
Experimental
Arm Description
Patients receive continuous control of cuff pressure with Pressure easy® device for 24h, followed by discontinuous control (every 4 hours) with a manual manometer for 24 h.
Arm Title
Manual control of Pcuff followed by continuous control.
Arm Type
Active Comparator
Arm Description
Patients receive the reverse sequence (manual control followed by continuous control of Pcuff)
Intervention Type
Device
Intervention Name(s)
Pressure easy® device
Other Intervention Name(s)
Pressure easy® device (Smiths medical cuff pressure controller)
Intervention Description
Continuous control of tracheal cuff pressure using a mechanical device for 24h 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
Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical 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 two 24-h periods (with or without Pressure easy® 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 polyvinyl chloride (PVC) cuffed tracheal tube. Predicted duration of mechanical ventilation > or = 48h. Age > or = 18 years. Signed informed consent. Exclusion Criteria: Anticipated duration of mechanical ventilation<48h after randomization. Tracheostomized patients. Patients with contraindication for semirecumbent position. Patients participating to another trial that might influence this study results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey Rodriguez, MD
Organizational Affiliation
Critical Care Unit. Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Area de Críticos, Hospital de Sabadell, Corporación Sanitaria y Universitaria Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26059205
Citation
Nseir S, Rodriguez A, Saludes P, De Jonckheere J, Valles J, Artigas A, Martin-Loeches I. Efficiency of a mechanical device in controlling tracheal cuff pressure in intubated critically ill patients: a randomized controlled study. Ann Intensive Care. 2015 Dec;5(1):54. doi: 10.1186/s13613-015-0054-z. Epub 2015 Jun 2.
Results Reference
derived

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Efficiency of a Mechanical Device in Controlling Tracheal Cuff Pressure in Intubated Critically Ill Patients

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