BIP ETT Clinical Tolerability, Safety and Performance Study

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating

Conditions
-----------------
Endotracheal Intubation During Surgery, Hospital Acquired Infections

Intervention / Treatment
-----------------
* Device: BIP ETT (Bactiguard)
* Procedure: Standard ETT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIP ETT, Bactigaurd coated endotracheal tube<br> | Device: BIP ETT (Bactiguard)<br>* Ventilation of surgery patients during anesthesia using BIP ETT<br>* Other names: Bactiguard coated Endotracheal tube;|
| Placebo Comparator: Standard ETT, un-coated endotracheal tube<br> | Procedure: Standard ETT<br>* Ventilation of surgery patients during anesthesia using standard ETT<br>* Other names: Uncoated Endotracheal tube;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The performance will be followed during surgery of an expected average duration of 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical device, Endotracheal Tube(s), ETT, Bactiguard Coated ETT, Tolerability, Safety, Performance, Bacterial colonization on ETT surface, Hospital Acquired Infections, HAI, Ventilator Associated Pneumonia, VAP