NCT01682486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 20, 2016

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

August 30, 2012

Last Update Submit

June 17, 2016

Conditions

Endotracheal Intubation During SurgeryHospital Acquired Infections

Keywords

Medical deviceEndotracheal Tube(s), ETTBactiguard Coated ETTTolerabilitySafetyPerformanceBacterial colonization on ETT surfaceHospital Acquired Infections, HAIVentilator Associated Pneumonia, VAP

Outcome Measures

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.

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

Secondary Outcomes (2)

  • 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

Other Outcomes (1)

  • Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface

    Microbial testing up to 1 day after surgery

Study Arms (2)

BIP ETT, Bactigaurd coated endotracheal tube

EXPERIMENTAL
Device: BIP ETT (Bactiguard)

Standard ETT, un-coated endotracheal tube

PLACEBO COMPARATOR
Procedure: Standard ETT

Interventions

BIP ETT (Bactiguard)DEVICE

Ventilation of surgery patients during anesthesia using BIP ETT

Also known as: BIP Endotracheal tube, Bactiguard coated ETT, Bactiguard coated Endotracheal tube
BIP ETT, Bactigaurd coated endotracheal tube
Standard ETTPROCEDURE

Ventilation of surgery patients during anesthesia using standard ETT

Also known as: ETT, Endotracheal tube, Standard Endotracheal tube, Uncoated ETT, Uncoated Endotracheal tube
Standard ETT, un-coated endotracheal tube

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Huddinge, Stockholm County, SE-141 86, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 26625869RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sigridur Kalman, MD PhD Prof

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2012

First Posted

September 11, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 20, 2016

Record last verified: 2014-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)