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Tracheobronchial Secretion Removal

Primary Purpose

Respiration, Artificial, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TBA care device
Control
Sponsored by
University of Milano Bicocca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Respiration, Artificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

  • age greater than 18 years
  • presence of an endotracheal tube to provide mechanical ventilation
  • expected duration of mechanical ventilation greater than 48 hours.

Exclusion Criteria:

  • age < 18 years, pregnancy
  • presence of active bronchial bleeding

Sites / Locations

  • A.O. San Gerardo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TBA

Control

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2009
Last Updated
July 2, 2009
Sponsor
University of Milano Bicocca
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1. Study Identification

Unique Protocol Identification Number
NCT00932776
Brief Title
Tracheobronchial Secretion Removal
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Milano Bicocca

4. Oversight

5. Study Description

Brief Summary
Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiration, Artificial, Respiratory Insufficiency

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
TBA
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
TBA care device
Intervention Description
Tracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: age greater than 18 years presence of an endotracheal tube to provide mechanical ventilation expected duration of mechanical ventilation greater than 48 hours. Exclusion Criteria: age < 18 years, pregnancy presence of active bronchial bleeding
Facility Information:
Facility Name
A.O. San Gerardo
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21276316
Citation
Lucchini A, Zanella A, Bellani G, Gariboldi R, Foti G, Pesenti A, Fumagalli R. Tracheal secretion management in the mechanically ventilated patient: comparison of standard assessment and an acoustic secretion detector. Respir Care. 2011 May;56(5):596-603. doi: 10.4187/respcare.00909. Epub 2011 Jan 27.
Results Reference
derived

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Tracheobronchial Secretion Removal

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