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

June 17, 2016 updated by: Bactiguard AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Huddinge, Stockholm, Sweden, SE-141 86
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Participants will be followed on the surgery day and the day after surgery
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
The performance will be followed during surgery of an expected average duration of 5 hours

Other Outcome Measures

Outcome Measure
Time Frame
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
Microbial testing up to 1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bactiguard AB

Investigators

  • Principal Investigator: Sigridur Kalman, MD PhD Prof, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

June 20, 2016

Last Update Submitted That Met QC Criteria

June 17, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1842-2026-CDOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hospital Acquired Infections

Clinical Trials on BIP ETT (Bactiguard)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe