BIP ETT Clinical Tolerability, Safety and Performance Study

NCT ID: NCT01682486

Last Updated: 2016-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Endotracheal Intubation During Surgery Hospital Acquired Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BIP ETT, Bactigaurd coated endotracheal tube

Group Type EXPERIMENTAL

BIP ETT (Bactiguard)

Intervention Type DEVICE

Ventilation of surgery patients during anesthesia using BIP ETT

Standard ETT, un-coated endotracheal tube

Group Type PLACEBO_COMPARATOR

Standard ETT

Intervention Type PROCEDURE

Ventilation of surgery patients during anesthesia using standard ETT

Interventions

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BIP ETT (Bactiguard)

Ventilation of surgery patients during anesthesia using BIP ETT

Intervention Type DEVICE

Standard ETT

Ventilation of surgery patients during anesthesia using standard ETT

Intervention Type PROCEDURE

Other Intervention Names

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BIP Endotracheal tube Bactiguard coated ETT Bactiguard coated Endotracheal tube ETT Endotracheal tube Standard Endotracheal tube Uncoated ETT Uncoated Endotracheal tube

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bactiguard AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigridur Kalman, MD PhD Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Huddinge, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.

Reference Type RESULT
PMID: 26625869 (View on PubMed)

Other Identifiers

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1842-2026-CDOC

Identifier Type: -

Identifier Source: org_study_id

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