BIP ETT Clinical Tolerability, Safety and Performance Study

Hospital Acquired Infections Clinical Trial

— BIPETT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682486
• Other study ID #: 1842-2026-CDOC
• Status: Completed
• Phase: N/A
• First received: August 30, 2012
• Last updated: June 17, 2016
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: July 2014
• Source: Bactiguard AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cross Infection
• Endotracheal Intubation During Surgery
• Hospital Acquired Infections

Intervention

Device:
• BIP ETT (Bactiguard)
Ventilation of surgery patients during anesthesia using BIP ETT

Procedure:
• Standard ETT
Ventilation of surgery patients during anesthesia using standard ETT

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Huddinge	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Bactiguard AB

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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

Outcome

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