BIP ETT Clinical Tolerability, Safety and Performance Study

Bactiguard AB30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Endotracheal Intubation During Surgery Hospital Acquired Infections

Interventions

BIP ETT (Bactiguard)DEVICE

Ventilation of surgery patients during anesthesia using BIP ETT

Standard ETTPROCEDURE

Ventilation of surgery patients during anesthesia using standard ETT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska University Hospital

Huddinge, Stockholm County, Sweden

Outcomes

Primary Outcomes

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

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

Overall assessment of device performance

Recording of any device related problems experienced by the physician/health care personnel

Time frame: The performance will be followed during surgery of an expected average duration of 5 hours

Data from ClinicalTrials.gov

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