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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bactiguard AB
ClinicalTrials.gov Identifier:
NCT01682486
First received: August 30, 2012
Last updated: July 1, 2014
Last verified: July 2014
  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 ]

Enrollment: 30
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682486

Locations
Sweden
Karolinska University Hospital
Huddinge, Stockholm, Sweden, SE-141 86
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: July 1, 2014
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 August 28, 2014