Back to resultsBIP ETT Clinical Tolerability, Safety and Performance Study (BIPETT)
Primary Purpose
Endotracheal Intubation During Surgery, Hospital Acquired Infections
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
BIP ETT (Bactiguard)
Standard ETT
Sponsored by
About this trial
This is an interventional supportive care trial for Endotracheal Intubation During Surgery focused on measuring 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
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
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BIP ETT, Bactigaurd coated endotracheal tube
Standard ETT, un-coated endotracheal tube
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall assessment of safety (device related adverse events and any problems in post postoperative course)
Overall assessment of device performance
Recording of any device related problems experienced by the physician/health care personnel
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01682486
Brief Title
BIP ETT Clinical Tolerability, Safety and Performance Study
Acronym
BIPETT
Official Title
Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bactiguard AB
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotracheal Intubation During Surgery, Hospital Acquired Infections
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIP ETT, Bactigaurd coated endotracheal tube
Arm Type
Experimental
Arm Title
Standard ETT, un-coated endotracheal tube
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
BIP ETT (Bactiguard)
Other Intervention Name(s)
BIP Endotracheal tube, Bactiguard coated ETT, Bactiguard coated Endotracheal tube
Intervention Description
Ventilation of surgery patients during anesthesia using BIP ETT
Intervention Type
Procedure
Intervention Name(s)
Standard ETT
Other Intervention Name(s)
ETT, Endotracheal tube, Standard Endotracheal tube, Uncoated ETT, Uncoated Endotracheal tube
Intervention Description
Ventilation of surgery patients during anesthesia using standard ETT
Primary Outcome Measure Information:
Title
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.
Time Frame
Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
Secondary Outcome Measure Information:
Title
Overall assessment of safety (device related adverse events and any problems in post postoperative course)
Time Frame
Participants will be followed on the surgery day and the day after surgery
Title
Overall assessment of device performance
Description
Recording of any device related problems experienced by the physician/health care personnel
Time Frame
The performance will be followed during surgery of an expected average duration of 5 hours
Other Pre-specified Outcome Measures:
Title
Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface
Time Frame
Microbial testing up to 1 day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigridur Kalman, MD PhD Prof
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26625869
Citation
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.
Results Reference
result
Learn more about this trial
BIP ETT Clinical Tolerability, Safety and Performance Study
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