NCT03117686

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 10, 2017

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

12 days

First QC Date

April 6, 2017

Last Update Submit

November 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • lung ultrasound

    Positive "B-line pattern" in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m)

    2 weeks

Secondary Outcomes (1)

  • optic nerve sheath diameter

    2 weeks

Study Arms (2)

healthy volunteers

10 healthy volunteers climbing Mount Kilimanjaro receiving lung ultrasound

Diagnostic Test: lung ultrasound

patients after lung transplantation

10 patients \> 2years after lung transplantation climbing Mount Kilimanjaro receiving lung ultrasound

Diagnostic Test: lung ultrasound

Interventions

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

healthy volunteerspatients after lung transplantation

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

10 patients \> 2 years after lung transplantation and 10 healthy volunteers during expedition to Mount Kilimanjaro

You may qualify if:

  • Expedition to Mount Kilimanjaro

You may not qualify if:

  • Refusal to participate in the study
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical university of vienna, General hospital of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Ulrike Weber, M.D.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass.Prof.Dr.

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 18, 2017

Study Start

June 10, 2017

Primary Completion

June 22, 2017

Study Completion

November 30, 2017

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations