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Completed

NCT Number: NCT01682486

BIP ETT Clinical Tolerability, Safety and Performance Study

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.

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Key information

Conditions

Endotracheal Intubation During Surgery Cross Infection Disease Attributes Healthcare-Associated Pneumonia Hospital Acquired Infections Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Huddinge, Stockholm County, SE-141 86, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIP ETT (Bactiguard)

Device

Ventilation of surgery patients during anesthesia using BIP ETT

Other names: BIP Endotracheal tube, Bactiguard coated ETT, Bactiguard coated Endotracheal tube

Standard ETT

Procedure

Ventilation of surgery patients during anesthesia using standard ETT

Other names: ETT, Endotracheal tube, Standard Endotracheal tube, Uncoated ETT, Uncoated Endotracheal tube

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bactiguard AB

Industry

Registry information

Official study title

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

Acronym: BIPETT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2012
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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