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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIP ETT, Bactigaurd coated endotracheal tube | Experimental |
| |
| Standard ETT, un-coated endotracheal tube | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIP ETT (Bactiguard) | Device | Ventilation of surgery patients during anesthesia using BIP ETT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Overall assessment of device performance | Recording of any device related problems experienced by the physician/health care personnel |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sigridur Kalman, MD PhD Prof | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Huddinge | Stockholm County | SE-141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26625869 | Result | Bjorling G, Johansson D, Bergstrom 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/s12871-015-0156-z. |
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
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| Standard ETT | Procedure | Ventilation of surgery patients during anesthesia using standard ETT |
|
|
| The performance will be followed during surgery of an expected average duration of 5 hours |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |