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NCT00932776 Clinical Trial

Tracheobronchial Secretion Removal

Respiratory Insufficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00932776
Other study ID # AR HSG 268
Secondary ID
Status Completed
Phase N/A
First received July 2, 2009
Last updated July 2, 2009

Study information
Verified date July 2009
Source University of Milano Bicocca
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

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.
• Control
In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.

Locations
Country Name City State
Italy A.O. San Gerardo Monza MB

Sponsors (1)
Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

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