Endotracheal Intubation During Surgery, Hospital Acquired Infections
Conditions
Keywords
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
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.
Interventions
DEVICEBIP ETT (Bactiguard)
Ventilation of surgery patients during anesthesia using BIP ETT
PROCEDUREStandard ETT
Ventilation of surgery patients during anesthesia using standard ETT
Sponsors
Bactiguard AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The performance will be followed during surgery of an expected average duration of 5 hours | Recording of any device related problems experienced by the physician/health care personnel |
Other
| Measure | 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 |
Countries
Sweden
Outcome results
None listed