Respiratory FailureNCT01949402
A New Way of Looking at Your Lungs
An observational study of Respiratory Failure and Acute Dyspnoea, run by University of Oxford at 1 site in United Kingdom.
Trial summary
There is increasing interest in how thoracic (chest) ultrasound might enhance the management of patients with respiratory failure and breathlessness, particularly in the emergency admissions or intensive care setting. Thoracic ultrasound is already used in a number of clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Acute Dyspnoea
- What is being tested?
- Computed Tomography, Thoracic ultrasound and Spirometry
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to 31 Jul 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be screened from normal clinical care in the outpatient haemodialysis unit and specialist respiratory clinics (COPD and ILD) at the Churchill Hospital, Oxford. Age-matched volunteers will also be sought for the control arm of the study.
Who may be able to join
- Haemodialysis (n=50) - patients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis.
- Chronic Obstructive Pulmonary Disease (COPD) (n=25) - patients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio <70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging).
- Interstitial Lung Disease (ILD) (n=25) - patients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging).
- Control (n=25) - age-matched healthy volunteers with no history of cardiac, respiratory or renal disease.
Who cannot join
- Age < 18 years
- Inability to provide informed consent to participate in the study
- Pregnant or breastfeeding
- Known diagnosis of heart failure or chronic renal failure in participants recruited to the COPD or ILD arms of the study.
- Known diagnosis of COPD or ILD in participants recruited to the haemodialysis arm of the study.
- Known history of cardiac, respiratory or renal disease in participants recruited to the control arm of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Ultrasonography in the Assessment of Extravascular Lung Water & Respiratory Failure
There is increasing interest in how thoracic (chest) ultrasound might enhance the management of patients with respiratory failure and breathlessness, particularly in the emergency admissions or intensive care setting. Thoracic ultrasound is already used in a number of clinical settings. It is recognised that a number of lung abnormalities can be identified using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive diagnostic tool that provides immediate feedback and results.
Patients with breathlessness and respiratory failure represent a significant proportion of emergency admissions to hospital and commonly require urgent treatment with limited information available to guide the clinician. The range of diseases that present with breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and difficult to differentiate in patients who often have multiple medical problems. This leads to non-specific treatment in the face of diagnostic uncertainty with the associated risks of treatment complications, increased morbidity and mortality, and distress for patients and relatives. It is in the assessment of these patients with acute respiratory failure where thoracic ultrasound might be of greatest benefit and which this research is designed to address.
This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over an eight month period. The study will test the reliability of a thoracic ultrasound protocol at identifying lung abnormalities in a stable outpatient population with respiratory disease (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study will inform further research in acutely unwell patients with respiratory failure and breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic decisions.
Read the detailed description
This is a prospective cohort study and forms part of educational research intended to ultimately contribute towards a higher degree (MD or DPhil). The study is being co-ordinated through the Oxford Respiratory Trials Unit, Churchill Hospital, Oxford and has been developed by the study co-ordinator (Dr Corcoran) and Chief Investigator (Dr Rahman) with support from Professor Gleeson.
This study will assess the efficacy of TUS in identifying extravascular lung water (EVLW) through the presence or absence of B-lines (also known as "comet tails") on ultrasound; whilst also determining whether TUS can distinguish between other pulmonary pathologies that may cause both a similar ultrasonographic appearance and respiratory compromise. A TUS protocol will be tested and validated in a stable patient population, concurrently assessing patient and operator satisfaction with the tool. It is intended that the results of this study will inform a larger second-phase study of a modified TUS protocol in the acute clinical setting (medical admissions unit +/- emergency department).
Potential participants in this study will be screened from normal clinical care in the relevant departments at the Churchill Hospital, Oxford - i.e. specialist COPD and ILD clinics in the respiratory department; outpatient haemodialysis units in the renal department. Healthy volunteers will also be sought using advertisements placed on noticeboards in the Oxford University Hospitals NHS Trust and selected Oxford University departments.
All participants enrolled in the study will undergo CT and thoracic ultrasound scanning as per the study protocol. These are low-risk interventions with no harm expected as a direct consequence of participation in the study.
Participants will also undergo baseline spirometry (if not done in the last month) and blood tests for the purposes of the study; these are also considered low-risk interventions with no harm expected as a direct consequence of participation in the study.
The study involves only a single visit and therefore it should impose a minimal burden on participants, and for the majority of participants their study visit will be arranged to coincide with a pre-arranged trip to the hospital for normal clinical care (e.g. a regular haemodialysis or outpatient clinic visit).
- Conditions
- Respiratory Failure, Acute Dyspnoea
- Being tested
- Computed Tomography, Thoracic ultrasound, Spirometry, Blood tests
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyOther
The CT scan will be performed on a 16 slice GE Discovery 670 SPECT CT scanner. A slice thickness of 0.625mm will be used. Images are acquired during an inspiratory breath hold of up to 20 seconds to minimise movement artefact. The patient will be lying supine and the scan will be a non-contrast study. Using a low dose CT chest protocol (1.7 mSv) will minimise the exposure to ionising radiation of study participants.
Participants in the haemodialysis arm of the study will have a CT done before and after haemodialysis. Participants in all other arms will have a single CT scan done during their study "visit".
Thoracic ultrasoundOther
The ultrasound will be performed by a single operator. The patient's position will ideally be with the patient sitting up at 45°. Ultrasound images and clips will be recorded at 10 points over each hemithorax - the 2nd, 4th and 6th intercostal spaces (ICS) in the mid-clavicular line; the 2nd, 4th and 6th ICS in the mid-axillary line; and the 2nd, 5th, 7th and 9th ICS posteriorly. Ultrasound estimation of the height of the right internal jugular vein will be undertaken. Central venous pressure will be calculated by adding 5cm. Inferior vena cava diameter will also be measured at end-inspiration and expiration. The time taken to perform each ultrasound will be recorded. Control, COPD and ILD groups will be scanned on a single occasion. Haemodialysis group will have 4 scans.
SpirometryOther
All participants in the study will undergo basic spirometry as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.
Blood testsOther
All participants in the study will undergo blood tests as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Haemodialysis | Patients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis. Receives: Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests | |
| Chronic Obstructive Pulmonary Disease | Patients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio <70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging). Receives: Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests | |
| Interstitial Lung Disease | Patients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging). Receives: Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests | |
| Control | Age-matched healthy volunteers with no history of cardiac, respiratory or renal disease. Receives: Other: Computed Tomography; Other: Thoracic ultrasound; Other: Spirometry; Other: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total lung ultrasound B-line score.
The total lung ultrasound B-line score (representing the presence of extravascular lung water) and changes in overall fluid status during haemodialysis.
Measured: At enrollment (1 single visit only)
Secondary outcomes (4)
Lung ultrasound identification of B-lines and differentiation between extravascular lung water
Lung ultrasound identification of B-lines and differentiation between extravascular lung water (EVLW) and other causes of this ultrasonographic appearance.
Measured: At enrollment (1 single visit only)
The lung ultrasound B-line score at differing anatomical locations around the thoracic cage
The lung ultrasound B-line score (representing the presence of EVLW) at differing anatomical locations around the thoracic cage and changes in overall fluid status during haemodialysis.
Measured: at enrollment (1 single visit only)
The total lung ultrasound B-line score
The total lung ultrasound B-line score (representing the presence of EVLW) and changes in patient breathlessness as measured by a visual analogue scale during haemodialysis.
Measured: At enrollment (1 single visit only)
Patient satisfaction with the thoracic ultrasound protocol
Patient satisfaction with the thoracic ultrasound protocol as measured using a Likert-type scale.
Measured: At enrollment (1 single visit only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completion31 Jul 2016
- Study completion31 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Najib Rahman, DPhil, Study chair, University of OxfordJohn Corcoran, BM BCh, Principal investigator, University of OxfordFergus Gleeson, Prof, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949402
- Sponsor's protocol ID
- TUS-EVLW1
- Status last verified
- May 2017
- First submitted
- 19 Sep 2013
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Ultrasonography in the Assessment of Extravascular Lung Water & Respiratory Failure
- ClinicalTrials.gov ID
- NCT01949402
- Acronym / sponsor ID
- TUS-EVLW1
- Conditions
- Respiratory Failure, Acute Dyspnoea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 31 Jul 2016 (actual)
- Study completion
- 31 Jul 2016 (actual)
- First posted
- 24 Sep 2013 (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.
There is increasing interest in how thoracic (chest) ultrasound might enhance the management of patients with respiratory failure and breathlessness, particularly in the emergency admissions or intensive care setting. Thoracic ultrasound is already used in a number of clinical settings. It is recognised that a number of lung abnormalities can be identified using thoracic ultrasound, such as consolidation (in pneumonia) or peripheral soft tissue lesions (in lung cancer). Furthermore, thoracic ultrasound offers clinicians a non-invasive diagnostic tool that provides immediate feedback and results.
Patients with breathlessness and respiratory failure represent a significant proportion of emergency admissions to hospital and commonly require urgent treatment with limited information available to guide the clinician. The range of diseases that present with breathing difficulties is broad (e.g. pneumonia, heart failure, pulmonary embolus) and difficult to differentiate in patients who often have multiple medical problems. This leads to non-specific treatment in the face of diagnostic uncertainty with the associated risks of treatment complications, increased morbidity and mortality, and distress for patients and relatives. It is in the assessment of these patients with acute respiratory failure where thoracic ultrasound might be of greatest benefit and which this research is designed to address.
This is a single centre study (Churchill Hospital, Oxford) recruiting 125 participants over an eight month period. The study will test the reliability of a thoracic ultrasound protocol at identifying lung abnormalities in a stable outpatient population with respiratory disease (chronic obstructive pulmonary disease; interstitial lung disease; patients on haemodialysis to replicate acute pulmonary oedema / heart failure). It is hoped the results of this study will inform further research in acutely unwell patients with respiratory failure and breathlessness to see whether thoracic ultrasound can improve diagnostic and therapeutic decisions.
Detailed description
This is a prospective cohort study and forms part of educational research intended to ultimately contribute towards a higher degree (MD or DPhil). The study is being co-ordinated through the Oxford Respiratory Trials Unit, Churchill Hospital, Oxford and has been developed by the study co-ordinator (Dr Corcoran) and Chief Investigator (Dr Rahman) with support from Professor Gleeson.
This study will assess the efficacy of TUS in identifying extravascular lung water (EVLW) through the presence or absence of B-lines (also known as "comet tails") on ultrasound; whilst also determining whether TUS can distinguish between other pulmonary pathologies that may cause both a similar ultrasonographic appearance and respiratory compromise. A TUS protocol will be tested and validated in a stable patient population, concurrently assessing patient and operator satisfaction with the tool. It is intended that the results of this study will inform a larger second-phase study of a modified TUS protocol in the acute clinical setting (medical admissions unit +/- emergency department).
Potential participants in this study will be screened from normal clinical care in the relevant departments at the Churchill Hospital, Oxford - i.e. specialist COPD and ILD clinics in the respiratory department; outpatient haemodialysis units in the renal department. Healthy volunteers will also be sought using advertisements placed on noticeboards in the Oxford University Hospitals NHS Trust and selected Oxford University departments.
All participants enrolled in the study will undergo CT and thoracic ultrasound scanning as per the study protocol. These are low-risk interventions with no harm expected as a direct consequence of participation in the study.
Participants will also undergo baseline spirometry (if not done in the last month) and blood tests for the purposes of the study; these are also considered low-risk interventions with no harm expected as a direct consequence of participation in the study.
The study involves only a single visit and therefore it should impose a minimal burden on participants, and for the majority of participants their study visit will be arranged to coincide with a pre-arranged trip to the hospital for normal clinical care (e.g. a regular haemodialysis or outpatient clinic visit).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Haemodialysis | – | Other: Computed Tomography, Other: Thoracic ultrasound, Other: Spirometry, Other: Blood testsPatients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis. |
| Chronic Obstructive Pulmonary Disease | – | Other: Computed Tomography, Other: Thoracic ultrasound, Other: Spirometry, Other: Blood testsPatients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio <70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging). |
| Interstitial Lung Disease | – | Other: Computed Tomography, Other: Thoracic ultrasound, Other: Spirometry, Other: Blood testsPatients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging). |
| Control | – | Other: Computed Tomography, Other: Thoracic ultrasound, Other: Spirometry, Other: Blood testsAge-matched healthy volunteers with no history of cardiac, respiratory or renal disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be screened from normal clinical care in the outpatient haemodialysis unit and specialist respiratory clinics (COPD and ILD) at the Churchill Hospital, Oxford. Age-matched volunteers will also be sought for the control arm of the study.
Key inclusion criteria (4 listed)
- Haemodialysis (n=50) - patients with end-stage renal failure (ESRF) requiring long-term regular haemodialysis.
- Chronic Obstructive Pulmonary Disease (COPD) (n=25) - patients with a confirmed diagnosis of COPD based on clinical history, obstructive spirometry (FEV1/VC ratio <70%) and radiology (e.g. hyperexpansion on plain chest radiograph; evidence of small airways disease or emphysema on cross-sectional imaging).
- Interstitial Lung Disease (ILD) (n=25) - patients with a confirmed diagnosis of ILD based on clinical history and radiology (evidence of ILD on cross-sectional imaging).
- Control (n=25) - age-matched healthy volunteers with no history of cardiac, respiratory or renal disease.
Key exclusion criteria (6 listed)
- Age < 18 years
- Inability to provide informed consent to participate in the study
- Pregnant or breastfeeding
- Known diagnosis of heart failure or chronic renal failure in participants recruited to the COPD or ILD arms of the study.
- Known diagnosis of COPD or ILD in participants recruited to the haemodialysis arm of the study.
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 |
|---|---|---|
| Computed TomographyThe CT scan will be performed on a 16 slice GE Discovery 670 SPECT CT scanner. A slice thickness of 0.625mm will be used. Images are acquired during an inspiratory breath hold of up to 20 seconds to minimise movement artefact. The patient will be lying supine and the scan will be a non-contrast study. Using a low dose CT chest protocol (1.7 mSv) will minimise the exposure to ionising radiation of study participants. Participants in the haemodialysis arm of the study will have a CT done before and after haemodialysis. Participants in all other arms will have a single CT scan done during their study "visit". | Other | Chronic Obstructive Pulmonary Disease, Control, Haemodialysis, Interstitial Lung Disease |
| Thoracic ultrasoundThe ultrasound will be performed by a single operator. The patient's position will ideally be with the patient sitting up at 45°. Ultrasound images and clips will be recorded at 10 points over each hemithorax - the 2nd, 4th and 6th intercostal spaces (ICS) in the mid-clavicular line; the 2nd, 4th and 6th ICS in the mid-axillary line; and the 2nd, 5th, 7th and 9th ICS posteriorly. Ultrasound estimation of the height of the right internal jugular vein will be undertaken. Central venous pressure will be calculated by adding 5cm. Inferior vena cava diameter will also be measured at end-inspiration and expiration. The time taken to perform each ultrasound will be recorded. Control, COPD and ILD groups will be scanned on a single occasion. Haemodialysis group will have 4 scans. | Other | Chronic Obstructive Pulmonary Disease, Control, Haemodialysis, Interstitial Lung Disease |
| SpirometryAll participants in the study will undergo basic spirometry as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study. | Other | Chronic Obstructive Pulmonary Disease, Control, Haemodialysis, Interstitial Lung Disease |
| Blood testsAll participants in the study will undergo blood tests as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study. | Other | Chronic Obstructive Pulmonary Disease, Control, Haemodialysis, Interstitial Lung Disease |
Primary outcome
The total lung ultrasound B-line score.
Time frame: At enrollment (1 single visit only)
The total lung ultrasound B-line score (representing the presence of extravascular lung water) and changes in overall fluid status during haemodialysis.
4 secondary outcomes
Lung ultrasound identification of B-lines and differentiation between extravascular lung water
Time frame: At enrollment (1 single visit only)
The lung ultrasound B-line score at differing anatomical locations around the thoracic cage
Time frame: at enrollment (1 single visit only)
The total lung ultrasound B-line score
Time frame: At enrollment (1 single visit only)
Patient satisfaction with the thoracic ultrasound protocol
Time frame: At enrollment (1 single visit only)
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 16 May 2017.
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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.
Najib Rahman, DPhil study chair
University of Oxford
John Corcoran, BM BCh principal investigator
University of Oxford
Fergus Gleeson, Prof principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Acute Dyspnoea, run by University of Oxford 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 4 inclusion and 6 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 16 May 2017. 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?
The total lung ultrasound B-line score. (time frame: At enrollment (1 single visit only)). 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 16 May 2017.