Pulmonary EdemaNCT03117686
Lung Ultrasound in High Altitude Lung Edema
An observational study of Pulmonary Edema, run by Medical University of Vienna at 1 site in Austria.
Trial summary
High altitude pulmonary edema is a life-threatening condition that remains a concern for climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at altitudes exceeding 3000m in non-acclimatised individuals. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- lung ultrasound
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jun 2017to 30 Nov 2017
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 patients > 2 years after lung transplantation and 10 healthy volunteers during expedition to Mount Kilimanjaro
Who may be able to join
- Expedition to Mount Kilimanjaro
Who cannot join
- Refusal to participate in the study
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical university of vienna, General hospital of Vienna
Vienna, 1090
About this study
Official title: Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: A Pilot Study
High altitude pulmonary edema is a life-threatening condition that remains a concern for climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at altitudes exceeding 3000m in non-acclimatised individuals. Recently, studies conducted in remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to altitude. the investigators want to assess the occurrence of of comet tails (B lines) as a measure of pulmonary edema among patients after lung transplantation and healthy individuals during an expedition to Mount Kilimanjaro.
Read the detailed description
High altitude pulmonary edema is a life-threatening condition that remains a concern for climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at altitudes exceeding 3000m in non-acclimatised individuals. Within the last decade, studies have shown ultrasonography to be valuable in the accurate diagnosis of a variety of lung pathologies, including cardiogenic pulmonary edema, pleural effusion, pneumothorax, and lung consolidation. Recently, studies conducted in remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to altitude. These studies also demonstrated that small portable ultrasound devices are reliable at high altitude in a cold and hypobaric environment.
So far all studies concerning the detection of comet tails as a measure of pulmonary edema have been done only in a healthy population. There is no study evaluating this topic in patients after lung transplantation.
Study objectives (Hypothesis)
The investigators want to assess the occurrence of of comet tails (B lines) as a measure of pulmonary edema among patients after lung transplantation and healthy individuals during an expedition to Mount Kilimanjaro.
Study design
Prospective observational single-center study.
Study population
10 patients > 2 years after lung transplantation and 10 healthy volunteers
Methods
The investigators will do the ultrasound examinations using the portable V-scan ultrasonography device (GE Healthcare) with a dual probe, including a phased array cardiac probe on one side and a linear probe on the other side.
Examinations will be done at sea level (before and right after the expedition), on the 3rd day at Shira hut at 3840 m and on the 6th day at Barafu camp at 4600m (highest camp site before summiting). Examinations will be done at the camp sites in a tent to assure good examination conditions for the patients.
Lung ultrasound will be performed with the patient in supine position. The phased-array transducer will be used for lung ultrasound, and will be used for the assessment of B-lines, which arise from the pleural line to the bottom of the screen and move with the sliding lung. The investigators will quantify the B- line burden in lung regions using the validated Eight-region method: Each hemithorax is divided into four quadrants, upper and lower anterior and upper and lower lateral divided longitudinally by the anterior axillary line and transversely by the 2nd intercostal space. If 3 or more B-lines (any size and spaced apart by any distance) are present in a particular region, that region is considered positive. Two or more positive regions per side define a "B-line pattern."
Measurement of optic nerve sheath diameter will be performed with a linear transducer placed superior and lateral to the eye, above the upper eyelid. The patient will be positioned supine, with a 30 degree head elevation. After visualization of the entry of the optic nerve into the globe, we will freeze the image. Optic nerve sheath diameter will be measured 3mm behind the globe in a perpendicular axis to the nerve. Two measurements will be taken per eye, and the mean of the 4 values will represent the optic nerve sheath diameter. A nerve sheath diameter of more than 5.8mm is defined as equivalent with an intracranial pressure (ICP) of more than 20mmHg.
- Conditions
- Pulmonary Edema
- Being tested
- lung ultrasound
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDiagnostic test
lung ultrasound with positive "B-line pattern" in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m) at Mountb Kilimanjaro
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | 10 healthy volunteers climbing Mount Kilimanjaro receiving lung ultrasound Receives: Diagnostic Test: lung ultrasound | |
| patients after lung transplantation | 10 patients > 2years after lung transplantation climbing Mount Kilimanjaro receiving lung ultrasound Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound
Positive "B-line pattern" in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m)
Measured: 2 weeks
Secondary outcomes (1)
optic nerve sheath diameter
optic nerve sheath diameter in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start10 Jun 2017
- Primary completion22 Jun 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Weber, Medical University of Vienna
- Investigators
- Ulrike Weber, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117686
- Sponsor's protocol ID
- 1236/2017
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: A Pilot Study
- ClinicalTrials.gov ID
- NCT03117686
- Acronym / sponsor ID
- 1236/2017
- Conditions
- Pulmonary Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 22 Jun 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
High altitude pulmonary edema is a life-threatening condition that remains a concern for climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at altitudes exceeding 3000m in non-acclimatised individuals. Recently, studies conducted in remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to altitude. the investigators want to assess the occurrence of of comet tails (B lines) as a measure of pulmonary edema among patients after lung transplantation and healthy individuals during an expedition to Mount Kilimanjaro.
Detailed description
High altitude pulmonary edema is a life-threatening condition that remains a concern for climbers and clinicians alike. It is defined as a non-cardiac pulmonary edema occurring at altitudes exceeding 3000m in non-acclimatised individuals. Within the last decade, studies have shown ultrasonography to be valuable in the accurate diagnosis of a variety of lung pathologies, including cardiogenic pulmonary edema, pleural effusion, pneumothorax, and lung consolidation. Recently, studies conducted in remote areas have demonstrated that ultrasound lung comets (B lines) can be used as a measure of sub-acute pulmonary edema and high altitude pulmonary edema in climbers ascending to altitude. These studies also demonstrated that small portable ultrasound devices are reliable at high altitude in a cold and hypobaric environment.
So far all studies concerning the detection of comet tails as a measure of pulmonary edema have been done only in a healthy population. There is no study evaluating this topic in patients after lung transplantation.
Study objectives (Hypothesis)
The investigators want to assess the occurrence of of comet tails (B lines) as a measure of pulmonary edema among patients after lung transplantation and healthy individuals during an expedition to Mount Kilimanjaro.
Study design
Prospective observational single-center study.
Study population
10 patients > 2 years after lung transplantation and 10 healthy volunteers
Methods
The investigators will do the ultrasound examinations using the portable V-scan ultrasonography device (GE Healthcare) with a dual probe, including a phased array cardiac probe on one side and a linear probe on the other side.
Examinations will be done at sea level (before and right after the expedition), on the 3rd day at Shira hut at 3840 m and on the 6th day at Barafu camp at 4600m (highest camp site before summiting). Examinations will be done at the camp sites in a tent to assure good examination conditions for the patients.
Lung ultrasound will be performed with the patient in supine position. The phased-array transducer will be used for lung ultrasound, and will be used for the assessment of B-lines, which arise from the pleural line to the bottom of the screen and move with the sliding lung. The investigators will quantify the B- line burden in lung regions using the validated Eight-region method: Each hemithorax is divided into four quadrants, upper and lower anterior and upper and lower lateral divided longitudinally by the anterior axillary line and transversely by the 2nd intercostal space. If 3 or more B-lines (any size and spaced apart by any distance) are present in a particular region, that region is considered positive. Two or more positive regions per side define a "B-line pattern."
Measurement of optic nerve sheath diameter will be performed with a linear transducer placed superior and lateral to the eye, above the upper eyelid. The patient will be positioned supine, with a 30 degree head elevation. After visualization of the entry of the optic nerve into the globe, we will freeze the image. Optic nerve sheath diameter will be measured 3mm behind the globe in a perpendicular axis to the nerve. Two measurements will be taken per eye, and the mean of the 4 values will represent the optic nerve sheath diameter. A nerve sheath diameter of more than 5.8mm is defined as equivalent with an intracranial pressure (ICP) of more than 20mmHg.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Diagnostic Test: lung ultrasound10 healthy volunteers climbing Mount Kilimanjaro receiving lung ultrasound |
| patients after lung transplantation | – | Diagnostic Test: lung ultrasound10 patients > 2years after lung transplantation climbing Mount Kilimanjaro receiving lung ultrasound |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients > 2 years after lung transplantation and 10 healthy volunteers during expedition to Mount Kilimanjaro
Key inclusion criteria (1 listed)
- Expedition to Mount Kilimanjaro
Key exclusion criteria (2 listed)
- Refusal to participate in the study
- Age < 18 years
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 |
|---|---|---|
| lung ultrasoundlung ultrasound with positive "B-line pattern" in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m) at Mountb Kilimanjaro | Diagnostic test | healthy volunteers, patients after lung transplantation |
Primary outcome
lung ultrasound
Time frame: 2 weeks
Positive "B-line pattern" in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m)
1 secondary outcome
optic nerve sheath diameter
Time frame: 2 weeks
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 2 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Edema
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Cardiogenic Shock, Pulmonary Edema Cardiac Cause
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High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
High-altitude Pulmonary Edema
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Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Not yet recruitingObservational study
Detecting Early Weaning-induced Pulmonary Oedema Using Lung Impedance Negative Trend During Spontaneous Breathing Trials
Weaning-induced Pulmonary Edema, Mechanical Ventilation Weaning
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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.
Ulrike Weber, M.D. principal investigator
Medical University of Vienna
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 Pulmonary Edema, run by Medical University of Vienna at 1 site in Austria.
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 2 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 2 Dec 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 Austria. 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?
lung ultrasound (time frame: 2 weeks). 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 2 Dec 2017.