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

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ClinicalTrials.gov Identifier: NCT01682486
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

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
Primary Completion Date : January 2013
Study Completion Date : January 2013
Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): 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
More Information

Publications:
Responsible Party: Bactiguard AB
ClinicalTrials.gov 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
Tolerability
Safety
Performance
Bacterial colonization on ETT surface
Hospital Acquired Infections, HAI
Ventilator Associated Pneumonia, VAP

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