Hospital Acquired Infections Clinical Trial
— BIPETTOfficial title:
Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
Verified date | July 2014 |
Source | Bactiguard AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult men and women >=18 years of age - are, in opinion of the investigator able to communicate with and understand the trial personnel and comply with the requirements of the trial (e.g. fill in questionnaire) - requiring endotracheal intubation >=3 h for elective surgery of upper gastrointestinal tract with a tube size of 7 or 8 - has signed informed consent Exclusion Criteria: - known transmissive blood disease - known multiresistant bacterial colonization - current and continuous treatment by immunomodulating therapies - e.g. systemic (or inhalation) use of cortisone or NSAIDS - ongoing respiratory infection |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Huddinge | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Bactiguard AB |
Sweden,
Björling G, Johansson D, Bergström L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface | Microbial testing up to 1 day after surgery | No | |
Primary | Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos. | Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours | No | |
Secondary | Overall assessment of safety (device related adverse events and any problems in post postoperative course) | Participants will be followed on the surgery day and the day after surgery | Yes | |
Secondary | Overall assessment of device performance | Recording of any device related problems experienced by the physician/health care personnel | The performance will be followed during surgery of an expected average duration of 5 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00976638 -
Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares
|
N/A | |
Completed |
NCT03795090 -
A Multi-level Antimicrobial Surface Coating for a Healthier Environment
|
Phase 2/Phase 3 |