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

Bactiguard

Status: Completed

Conditions: Endotracheal Intubation During Surgery; Hospital Acquired Infections

Treatments: Device: BIP ETT (Bactiguard); Procedure: Standard ETT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682486

1842-2026-CDOC

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

BIP ETT, Bactigaurd coated endotracheal tube

Experimental group

Treatment:

Device: BIP ETT (Bactiguard)

Standard ETT, un-coated endotracheal tube

Placebo Comparator group

Treatment:

Procedure: Standard ETT