Critically Ill Clinical Trial
Official title:
Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.
The purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admission to Medical, Surgical or Neuro ICU - Subjects must be enrolled within 24 hours from intubation - Subjects expected to be intubated for at least 48 hours or longer - Subjects have been intubated with a silver-coated ETT Exclusion Criteria: - Current and past participation in another interventional trial conflicting with the present study - Pregnant women - Prisoner status |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Brigham and Women's Hospital, Rhode Island Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endotracheal tube colonization | Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation | At extubation (an expected average of 7 days) | No |
Secondary | Microbiological colonization of distal airways | Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a sample of tracheal aspirate immediately before extubation. | At extubation (An expected average of 7 days) | No |
Secondary | ETT microscopic imaging | Samples of ETT will be collected and stored for Scanned Electron Microscopy and Confocal Laser Scanning Microscopy with dead/alive staining | At extubation (An expected average of 7 days) | No |
Secondary | In-vivo respiratory mechanics | Data about respiratory mechanics will be obtained in both groups for each enrolled patient three times a day (q8 hours). These measurements are safe non-invasive. They will require the RT to register pressure, volume and flow parameters from the ventilator in use on the patient. | At extubation (An expected average of 7 days) | No |
Secondary | Drug resistance testing | Investigators will test drug resistances found in isolates of distal airways, tracheal aspirate and inner ETT surface | At extubation (An expected average of 7 days) | No |
Secondary | Infective Processes and Clinical Outcomes | Investigators will keep track of patient data regarding ETT-related infections as well as data about ICU clinical outcomes (hours of mechanical ventilation, days of ICU stay, mortality, occurrence of tracheostomy and occurrence of ETT exchange) | At extubation (An expected average of 7 days) | No |
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