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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01682486
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : June 20, 2016
Information provided by (Responsible Party):
Bactiguard AB

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.

Condition or disease Intervention/treatment Phase
Endotracheal Intubation During Surgery Hospital Acquired Infections Device: BIP ETT (Bactiguard) Procedure: Standard ETT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Overall assessment of device performance [ Time Frame: 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 Outcome Measures:
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01682486

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Karolinska University Hospital
Huddinge, Stockholm, Sweden, SE-141 86
Sponsors and Collaborators
Bactiguard AB
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Principal Investigator: Sigridur Kalman, MD PhD Prof Karolinska University Hospital

Publications of Results:
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Responsible Party: Bactiguard AB Identifier: NCT01682486     History of Changes
Other Study ID Numbers: 1842-2026-CDOC
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: July 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bactiguard AB:
Medical device
Endotracheal Tube(s), ETT
Bactiguard Coated ETT
Bacterial colonization on ETT surface
Hospital Acquired Infections, HAI
Ventilator Associated Pneumonia, VAP

Additional relevant MeSH terms:
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Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes