Respiratory InsufficiencyNCT02284438
Biofilm Formation on Different Endotracheal Tube Materials
A study testing Endotracheal tube in people with Respiratory Insufficiency and Ventilator-associated Pneumonia, run by Region Skane at 1 site in Sweden.
Trial summary
Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs. Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Ventilator-associated Pneumonia
- What is being tested?
- Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2014to Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients needing invasive mechanical ventilation through an endotracheal tube
Who cannot join
- Anticipated need for mechanical ventilation less than 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innovation Against Infection - Device Related Infections - Part ETT
Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.
Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.
Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.
Read the detailed description
Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.
It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.
In this study the investigators will compare microbiology and EM images in that same manner.
Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.
Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.
ICU patients needing mechanical ventilation will be intubated with the three different devices with different surfaces characteristics.
The tubes are: A - standard Poly vinyl chloride (PVC) tube; B - PVC with a silicon coating; C - PVC with a special metal film coating
- Being tested
- Endotracheal tube
- Keywords
- ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia
- Medical subject headings
- Respiratory Insufficiency, Pneumonia, Ventilator-Associated, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tubeDevice
Three endotracheal tubes with different surfaces will be used
| Study group | Role | What they receive |
|---|---|---|
| Biofilm formation on ETT | Other | Three different endotracheal tubes uses on intubated mechanical ventilated patients will after extubation be examined regarding biofilm, structure and presence of microbes on the ETTs The different tubes will be used during consecutive time periods The study does not include any interventions concerning the treatment of these critically ill patients Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
Pieces of the tubes examined with electron microscopy and assessed for microbes
Measured: After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Secondary outcomes (4)
White Blood Cell count
Blood samples taken daily
Measured: From admission to extubation. Expected average 5 days
C reactive protein
Blood samples taken daily
Measured: From admission to extubation. Expected average 5 days
Length of stay, ICU and Hospital
Length of stay in Hospital and for the ICU stay
Measured: Three months from study inclusion
Survival
For participating patients the status of survival or non survival at days 28 and 90 (three months)
Measured: Three months from study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2017
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Vinnova, Bactiguard AB
- Responsible party
- Principal investigator, Bengt Klarin, Region Skane
- Investigators
- Bengt Klarin, MD, PhD, Principal investigator, Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284438
- Sponsor's protocol ID
- IMI-ETT
- Status last verified
- Dec 2018
- First submitted
- 21 Oct 2014
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will be published as an article in a scientific journal
Publications
Gil-Perotin S, Ramirez P, Marti V, Sahuquillo JM, Gonzalez E, Calleja I, Menendez R, Bonastre J. Implications of endotracheal tube biofilm in ventilator-associated pneumonia response: a state of concept. Crit Care. 2012 May 23;16(3):R93. doi: 10.1186/cc11357.
PubMed 22621676Thorarinsdottir HR, Kander T, Holmberg A, Petronis S, Klarin B. Biofilm formation on three different endotracheal tubes: a prospective clinical trial. Crit Care. 2020 Jun 29;24(1):382. doi: 10.1186/s13054-020-03092-1.
PubMed 32600373
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation Against Infection - Device Related Infections - Part ETT
- ClinicalTrials.gov ID
- NCT02284438
- Acronym / sponsor ID
- IMI-ETT
- Keywords
- ETT, Biofilm, Mechanical ventilation, Critical illness, Ventilator-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Vinnova, Bactiguard AB
- Study start
- Apr 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three endotracheal tubes (ETTs) with different surfaces properties will be studied regarding formation and structure of the biofilm formed on those ETTs.
Cultures from oropharynx and tracheal secretions as well as pieces of the ETT will be examined.
Findings from electron microscopy (EM) and microbiology will be analyzed and compared in respect to the three materials.
Detailed description
Ventilator associated pneumonia (VAP) is a frequent and costly complication to mechanical ventilation in critically ill patients. Aspiration of oropharyngeal secretions and fragments of biofilm from the endotracheal tube are the main causes of VAP.
It is well known that biofilm is formed on medical devices and several initiatives to reduce the development of such biofilms have been taken. However it is still a large clinical problem and colleagues have performed studies to find out the structure of the biofilms formed on the ETT and to what extent microbiological findings correlate to images from EM.
In this study the investigators will compare microbiology and EM images in that same manner.
Three different ETTs will be examined. The investigators will be using each of the three ETTs for a period of time sufficient to retrieve samples from at least 20 ETTs of each kind.
Only one kind of ETT will be used during the specified time period, no randomization. The test will be performed in the order mentioned below A - B - C All of the three tubes are CE-marked (Conformité Européenne) and are available on the market.
ICU patients needing mechanical ventilation will be intubated with the three different devices with different surfaces characteristics.
The tubes are: A - standard Poly vinyl chloride (PVC) tube; B - PVC with a silicon coating; C - PVC with a special metal film coating
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biofilm formation on ETT | Other | Device: Endotracheal tubeThree different endotracheal tubes uses on intubated mechanical ventilated patients will after extubation be examined regarding biofilm, structure and presence of microbes on the ETTs The different tubes will be used during consecutive time periods The study does not include any interventions concerning the treatment of these critically ill patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients needing invasive mechanical ventilation through an endotracheal tube
Key exclusion criteria (1 listed)
- Anticipated need for mechanical ventilation less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal tubeThree endotracheal tubes with different surfaces will be used | Device | Biofilm formation on ETT |
Primary outcome
Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube
Time frame: After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days
Pieces of the tubes examined with electron microscopy and assessed for microbes
4 secondary outcomes
White Blood Cell count
Time frame: From admission to extubation. Expected average 5 days
C reactive protein
Time frame: From admission to extubation. Expected average 5 days
Length of stay, ICU and Hospital
Time frame: Three months from study inclusion
Survival
Time frame: Three months from study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Background: PubMed 22621676Gil-Perotin S, Ramirez P, Marti V, Sahuquillo JM, Gonzalez E, Calleja I, Menendez R, Bonastre J. Implications of endotracheal tube biofilm in ventilator-associated pneumonia response: a state of concept. Crit Care. 2012 May 23;16(3):R93. doi: 10.1186/cc11357.
- Derived from this study: PubMed 32600373Thorarinsdottir HR, Kander T, Holmberg A, Petronis S, Klarin B. Biofilm formation on three different endotracheal tubes: a prospective clinical trial. Crit Care. 2020 Jun 29;24(1):382. doi: 10.1186/s13054-020-03092-1.
- Sweden's innovation agencyLink provided by the sponsor.
- (Statens Provningsanstalt) SP Technical Research Institute of Sweden,Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Results will be published as an article in a scientific journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengt Klarin, MD, PhD principal investigator
Dept Anaesthesiology and Intensive care, Skåne University Hospital, Lund Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube in people with Respiratory Insufficiency and Ventilator-associated Pneumonia, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure, thickness, and presence of microbes of biofilm developed on endotracheal tube (time frame: After finished mechanical ventilation and extubation; expected average time on mechanical ventilation 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.