Intensive CareNCT01143961
Bedside Measurement of Ventilation With or Without a One-way Valve During Lung Lavage
A study testing CSC100 - Verso airway access adapter CareFusion in people with Intensive Care, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated patients as these individuals are at high risk of developing pneumonia. Knowledge of the types of bacteria present allows the rapid treatment with the correct antibiotics if a pneumonia develops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care
- What is being tested?
- CSC100 - Verso airway access adapter CareFusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Jan 2011
- 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 aged >18 years
- Patients in whom an NBL is indicated as part of standard treatment
- Patient on mechanical ventilation with PEEP
Who cannot join
- NBL contraindicated
- Age <18 years
- Patient not on mechanical ventilation with PEEP
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Adult Critical Care, University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW
About this study
Official title: Measurement of Changes in Ventilation and Catheter Placement During Non-directed Bronchoalveolar Lavage Using Electrical Impedance Tomography With and Without a One-way Valve
Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated patients as these individuals are at high risk of developing pneumonia. Knowledge of the types of bacteria present allows the rapid treatment with the correct antibiotics if a pneumonia develops. Surveillance is undertaken using a technique called non-directed bronchoalveolar lavage (NBL), which can be performed by the bedside nurse. This involves suctioning some of the lung secretions into a sample pot and sending it to the microbiology laboratory to identify any bacteria present. When this procedure is performed there is some collapse of the lung due to escaping gas. The purpose of this study is:
- To use a non-invasive imaging technique known as electrical impedance tomography (EIT) to measure the amount of lung collapse during an NBL. Half of the patients in the study will have a one-way adapter valve connected to the breathing circuit. This adapter is designed to make the insertion of a suction catheter easier and prevent the loss of gas.
- Look at which region of the lung the sample is being collected from as the suction tube used to take the samples may pass into either the left or right lung.
EIT is a simple non-invasive technique which has been in use for many years. It uses pairs of electrodes around the chest through which imperceptible currents are passed. A computer shows an image of which parts of the lungs have the most or least air in them. This has the advantage over other imaging techniques in critical care that it does not use radiation and gives a real time picture at the bedside of the variations in ventilation throughout the lungs.
Read the detailed description
This study has two objectives. The first is to measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount. This will be done by randomising half of the patients to having the one-way adapter valve attached to the catheter mount. Assignment will be by randomisation.
The second objective of the study is to locate the placement of catheter tips during the performance of NBLs, using electrical impedance tomography.
Equipment: A sixteen-electrode single frequency electrical impedance tomography device with on-line image analysis (CareFusion). One-way adapter valves which attach to the catheter mount (CareFusion).
Study Population: Critically ill adult patients admitted to the intensive care unit at the University Hospital of Wales Cardiff in whom NBLs are performed as part of their routine care.
Recruitment: All patients satisfying inclusion and exclusion criteria, admitted to the adult ICU at the University Hospital of Wales from the start date of the study will be considered eligible for recruitment. Patients identified by the duty consultant will be notified to the research team. Patients will be randomly allocated to have NBLs performed with or without the one-way valve attached to the catheter mount.
Since this is an observational pilot study a minimum of fifty patients will be identified.
Interventions: The second cohort of patients will have NBLs performed with the one-way adapter connected to the catheter mount, otherwise there will be no change will be made to the normal standard of care.
Method: Following cleaning of the skin with alcohol wipes sixteen ECG electrodes will be placed equidistantly from one another midway between sternum and umbilicus. A reference electrode will be placed on the right hand side of the chest. NBLs will be undertaken according to routine standards of care. In brief, this involves pre-oxygenating the patient, and inserting a suction catheter attached to a 20ml saline filled syringe through the catheter mount (25 patients) or adapter with one-way valve connected to the catheter mount (25 patients) until resistance is met. The saline is instilled and then slowly withdrawn to obtain a sample. Since saline is conductive, instillation results in a change in local impedance which is detected by the array of electrodes. The image obtained will identify into which region of the lung the catheter is placed. Any changes in the gas content of lung (due to loss of PEEP) will be manifest as changes in lung impedance and reflects a change in regional ventilation. NBLs are undertaken when clinically indicated and patients may have more than one recoding undertaken up to a maximum of three times.
Collection of other data: Baseline demographics of patients will be recorded, including age, sex, APACHE II score, co-morbidities, diagnosis, days from hospital admission. Ventilator settings - mode, inspired oxygen fraction, tidal and minute ventilation, compliance, PEEP and mean airway pressure will be recorded.
- Conditions
- Intensive Care
- Being tested
- CSC100 - Verso airway access adapter CareFusion
- Keywords
- Positive pressure ventilation, Electrical impedance tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSC100 - Verso airway access adapter CareFusionDevice
Also called One-way adapter valve
Following randomisation patients will have a one-way valve inserted into the ventilator circuit (CSC100 - Verso airway access adapter CareFusion) prior to a non-directed bronchoalveolar lavage (NBL) being performed. Changes in regional ventilation will be recorded by electrical impedance tomography during the NBL. Recordings of ventilation will take place for upto four hours. One-way valve will stay in place until ventilator circuit is changed.
| Study group | Role | What they receive |
|---|---|---|
| NBL with one-way valve | Experimental | NBL performed with one-way valve in ventilator circuit during procedure Receives: Device: CSC100 - Verso airway access adapter CareFusion |
| Standard NBL | No intervention | Performance of standard NBL with recording of changes in regional ventilation by electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount.
Measured: Up to 4 hours
Secondary outcomes (1)
Locate the placement of catheter tips during the performance of NBLs, using electrical impedance tomography
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Matt P Wise, DPhil, Principal investigator, University Hospital of Wales Cardiff & Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143961
- Sponsor's protocol ID
- 09/MRE09/54
- Status last verified
- Feb 2010
- First submitted
- 14 Jun 2010
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Changes in Ventilation and Catheter Placement During Non-directed Bronchoalveolar Lavage Using Electrical Impedance Tomography With and Without a One-way Valve
- ClinicalTrials.gov ID
- NCT01143961
- Acronym / sponsor ID
- 09/MRE09/54
- Conditions
- Intensive Care
- Keywords
- Positive pressure ventilation, Electrical impedance tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- Jun 2010 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Jun 2010 (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.
Surveillance of the lungs for bacteria is routinely undertaken in artificially ventilated patients as these individuals are at high risk of developing pneumonia. Knowledge of the types of bacteria present allows the rapid treatment with the correct antibiotics if a pneumonia develops. Surveillance is undertaken using a technique called non-directed bronchoalveolar lavage (NBL), which can be performed by the bedside nurse. This involves suctioning some of the lung secretions into a sample pot and sending it to the microbiology laboratory to identify any bacteria present. When this procedure is performed there is some collapse of the lung due to escaping gas. The purpose of this study is:
- To use a non-invasive imaging technique known as electrical impedance tomography (EIT) to measure the amount of lung collapse during an NBL. Half of the patients in the study will have a one-way adapter valve connected to the breathing circuit. This adapter is designed to make the insertion of a suction catheter easier and prevent the loss of gas.
- Look at which region of the lung the sample is being collected from as the suction tube used to take the samples may pass into either the left or right lung.
EIT is a simple non-invasive technique which has been in use for many years. It uses pairs of electrodes around the chest through which imperceptible currents are passed. A computer shows an image of which parts of the lungs have the most or least air in them. This has the advantage over other imaging techniques in critical care that it does not use radiation and gives a real time picture at the bedside of the variations in ventilation throughout the lungs.
Detailed description
This study has two objectives. The first is to measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount. This will be done by randomising half of the patients to having the one-way adapter valve attached to the catheter mount. Assignment will be by randomisation.
The second objective of the study is to locate the placement of catheter tips during the performance of NBLs, using electrical impedance tomography.
Equipment: A sixteen-electrode single frequency electrical impedance tomography device with on-line image analysis (CareFusion). One-way adapter valves which attach to the catheter mount (CareFusion).
Study Population: Critically ill adult patients admitted to the intensive care unit at the University Hospital of Wales Cardiff in whom NBLs are performed as part of their routine care.
Recruitment: All patients satisfying inclusion and exclusion criteria, admitted to the adult ICU at the University Hospital of Wales from the start date of the study will be considered eligible for recruitment. Patients identified by the duty consultant will be notified to the research team. Patients will be randomly allocated to have NBLs performed with or without the one-way valve attached to the catheter mount.
Since this is an observational pilot study a minimum of fifty patients will be identified.
Interventions: The second cohort of patients will have NBLs performed with the one-way adapter connected to the catheter mount, otherwise there will be no change will be made to the normal standard of care.
Method: Following cleaning of the skin with alcohol wipes sixteen ECG electrodes will be placed equidistantly from one another midway between sternum and umbilicus. A reference electrode will be placed on the right hand side of the chest. NBLs will be undertaken according to routine standards of care. In brief, this involves pre-oxygenating the patient, and inserting a suction catheter attached to a 20ml saline filled syringe through the catheter mount (25 patients) or adapter with one-way valve connected to the catheter mount (25 patients) until resistance is met. The saline is instilled and then slowly withdrawn to obtain a sample. Since saline is conductive, instillation results in a change in local impedance which is detected by the array of electrodes. The image obtained will identify into which region of the lung the catheter is placed. Any changes in the gas content of lung (due to loss of PEEP) will be manifest as changes in lung impedance and reflects a change in regional ventilation. NBLs are undertaken when clinically indicated and patients may have more than one recoding undertaken up to a maximum of three times.
Collection of other data: Baseline demographics of patients will be recorded, including age, sex, APACHE II score, co-morbidities, diagnosis, days from hospital admission. Ventilator settings - mode, inspired oxygen fraction, tidal and minute ventilation, compliance, PEEP and mean airway pressure will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NBL with one-way valve | Experimental | Device: CSC100 - Verso airway access adapter CareFusionNBL performed with one-way valve in ventilator circuit during procedure |
| Standard NBL | No intervention | –Performance of standard NBL with recording of changes in regional ventilation by electrical impedance tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged >18 years
- Patients in whom an NBL is indicated as part of standard treatment
- Patient on mechanical ventilation with PEEP
Key exclusion criteria (3 listed)
- NBL contraindicated
- Age <18 years
- Patient not on mechanical ventilation with PEEP
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 |
|---|---|---|
| CSC100 - Verso airway access adapter CareFusionAlso: One-way adapter valveFollowing randomisation patients will have a one-way valve inserted into the ventilator circuit (CSC100 - Verso airway access adapter CareFusion) prior to a non-directed bronchoalveolar lavage (NBL) being performed. Changes in regional ventilation will be recorded by electrical impedance tomography during the NBL. Recordings of ventilation will take place for upto four hours. One-way valve will stay in place until ventilator circuit is changed. | Device | NBL with one-way valve |
Primary outcome
Measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount.
Time frame: Up to 4 hours
1 secondary outcome
Locate the placement of catheter tips during the performance of NBLs, using electrical impedance tomography
Time frame: Up to 4 hours
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 31 Aug 2023.
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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.
Matt P Wise, DPhil principal investigator
University Hospital of Wales Cardiff & Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSC100 - Verso airway access adapter CareFusion in people with Intensive Care, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 3 inclusion and 3 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 31 Aug 2023. 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 United Kingdom. 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?
Measure changes in lung ventilation using EIT during the performance of an NBL with and without a one-way adapter valve attached to the catheter mount. (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.