- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117686
Lung Ultrasound in High Altitude Lung Edema
Estimation of Pulmonary Arterial Pressure With Transesophageal Echocardiography: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical university of vienna, General hospital of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Expedition to Mount Kilimanjaro
Exclusion Criteria:
- Refusal to participate in the study
- Age < 18 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
healthy volunteers
10 healthy volunteers climbing Mount Kilimanjaro receiving lung ultrasound
|
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
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patients after lung transplantation
10 patients > 2years after lung transplantation climbing Mount Kilimanjaro receiving lung ultrasound
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
optic nerve sheath diameter
Time Frame: 2 weeks
|
optic nerve sheath diameter in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m)
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1236/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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