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Tracheobronchial Secretion Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932776
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 3, 2009
Sponsor:
Information provided by:
University of Milano Bicocca

Tracking Information
First Submitted Date  ICMJE July 2, 2009
First Posted Date  ICMJE July 3, 2009
Last Update Posted Date July 3, 2009
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tracheobronchial Secretion Removal
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE
  • Respiration, Artificial
  • Respiratory Insufficiency
Intervention  ICMJE
  • Device: TBA care device
    Tracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first.
  • Device: Control
    In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.
Study Arms  ICMJE
  • Experimental: TBA
    Intervention: Device: TBA care device
  • Active Comparator: Control
    Intervention: Device: Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00932776
Other Study ID Numbers  ICMJE AR HSG 268
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Milano Bicocca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Milano Bicocca
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP