BIP ETT Clinical Tolerability, Safety and Performance Study (BIPETT)

This study is currently recruiting participants.
Verified September 2012 by Bactiguard AB
Sponsor:
Information provided by (Responsible Party):
Bactiguard AB
ClinicalTrials.gov Identifier:
NCT01682486
First received: August 30, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Endotracheal Intubation During Surgery
Hospital Acquired Infections
Device: BIP ETT (Bactiguard)
Procedure: Standard ETT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating

Further study details as provided by Bactiguard AB:

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. [ Time Frame: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Overall assessment of device performance [ Time Frame: The performance will be followed during surgery of an expected average duration of 5 hours ] [ Designated as safety issue: No ]
    Recording of any device related problems experienced by the physician/health care personnel


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIP ETT, Bactigaurd coated endotracheal tube Device: BIP ETT (Bactiguard)
Ventilation of surgery patients during anesthesia using BIP ETT
Other Names:
  • BIP Endotracheal tube
  • Bactiguard coated ETT
  • Bactiguard coated Endotracheal tube
Placebo Comparator: Standard ETT, un-coated endotracheal tube Procedure: Standard ETT
Ventilation of surgery patients during anesthesia using standard ETT
Other Names:
  • ETT
  • Endotracheal tube
  • Standard Endotracheal tube
  • Uncoated ETT
  • Uncoated Endotracheal tube

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682486

Contacts
Contact: Sigridur Kalman, MD PhD Prof +46703927101 sigridur.kalman@karolinska.se
Contact: Dorota Johansson, PhD dorota.johansson@bactiguard.se

Locations
Sweden
Karolinska University Hospital Recruiting
Huddinge, Stockholm, Sweden, SE-141 86
Contact: Sigridur Kalman, MD PhD Prof    +46703927101    sigridur.kalman@karolinska.se   
Principal Investigator: Sigridur Kalman, MD PhD Prof         
Sponsors and Collaborators
Bactiguard AB
Investigators
Principal Investigator: Sigridur Kalman, MD PhD Prof Karolinska University Hospital, Huddinge, Sweden
  More Information

No publications provided

Responsible Party: Bactiguard AB
ClinicalTrials.gov Identifier: NCT01682486     History of Changes
Other Study ID Numbers: 1842-2026-CDOC
Study First Received: August 30, 2012
Last Updated: September 10, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Bactiguard AB:
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

Additional relevant MeSH terms:
Cross Infection
Infection

ClinicalTrials.gov processed this record on April 15, 2014