BIP ETT Clinical Tolerability, Safety and Performance Study

Not Applicable

Completed

• Conditions: Hospital Acquired Infections; Endotracheal Intubation During Surgery
• Interventions: Device: BIP ETT (Bactiguard); Procedure: Standard ETT

• Registration Number: NCT01682486
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-11
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2014-07
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIP ETT, Bactigaurd coated endotracheal tube	BIP ETT (Bactiguard)	-
Standard ETT, un-coated endotracheal tube	Standard ETT	-

Primary Outcome Measures

Name	Time	Method
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.	Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours

Secondary Outcome Measures

Name	Time	Method
Overall assessment of safety (device related adverse events and any problems in post postoperative course)	Participants will be followed on the surgery day and the day after surgery
Overall assessment of device performance	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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Huddinge, Stockholm, Sweden