- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05769140
Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude
Measurement of Cardiopulmonary Variables in a Large Group of Healthy Subjects With Acute Exposure to High Altitude
As altitude increases, the availability of oxygen in the air decreases, and just to compensate for this lack, the body increases cardiac and respiratory work and changes blood pressure. But that is not all: at altitude the body's ability to use oxygen is also limited. Thus, there is on one hand less oxygen available, and on the other a lower capacity to use it. All this generates significant alterations at the cardiovascular level, to the point of running possible risks of heart attack, stroke and acute pulmonary edema, particularly for individuals already suffering from cardiovascular disease.
The availability of modern cable cars allows an increasingly large number of individuals, including sedentary people, elderly subjects, and cardiorespiratory patients, to easily and rapidly reach high-altitude locations. Data on what happens on the cardiovascular system at high altitude are relatively scarce, and most experiments in the literature are limited by low sample sizes.
The primary purpose of this study is to assess the characteristics of a large population that acutely reached high altitude at Punta Helbronner (3,466 m above sea level), a location on Mont Blanc that is readily accessible by a 20-minute cableway ride from Courmayeur (Entreves station, 1,300 m, Skyway Monte Bianco). We aim to create a unique database and study correlations between altitude and cardiorespiratory parameters (heart rate, blood pressure, and Hb saturation) by collecting medical history data and biometric measurements in a very large population and to identify subjects most at risk of developing hypoxia at altitude. In a subset of subjects, differences in biometric variables after acute exposure at high altitude (in the transition between the downstream and the upstream measuring station) will be evaluated.
Two biometric multiparametric recording systems (Keito K9; Keito, Barcelona, Spain) were installed at Entreves station as well as at Punta Helbronner. Keito K9 is an automatic multiparametric recoding system for measuring peripheral oxygen saturation SpO2, heart rate HR (pulse oximeter), blood pressure (BP; wrist pressure cuff, automatic), height (laser height meter), weight (scale platform), and body mass index (BMI). Once initiated by the subject with the completion of a cardiology history questionnaire (self-reported), the automated Keito K9 system provides a sequence of vocal and animated directions to guide subjects through the measurements (the subject may elect to abstain from some of the measurements). Upon completion, the system prints a summary receipt for the subject, and the measurements are transmitted through a Wi-Fi network and collected in an Excel sheet.
It should be noted that all data collected will be anonymized or not traceable to the subject, through the use of a disposable identification card (for subjects who will perform both downstream and upstream measurement).
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Piergiuseppe Agostoni, Prof
- Phone Number: +39 0258002772
- Email: piergiuseppe.agostoni@ccfm.it
Study Locations
-
-
Aosta
-
Courmayeur, Aosta, Italy, 11013
- Recruiting
- Skyway Monte Bianco
-
Contact:
- Carlo Vignati, MD
- Phone Number: +39 0258002834
- Email: carlo.vignati@ccfm.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
Exclusion Criteria:
- Age < 18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relationship between oxygen saturation after acute exposure to high altitude and age
Time Frame: immediately after the evaluation
|
determine if there is a relationship between oxygen saturation as % (pulse oximeter included in the biometric station) and age (self-reported in automated questionnaire included in the biometric station software and created ad hoc by research team) following acute exposure to high altitude
|
immediately after the evaluation
|
relationship between oxygen saturation after acute exposure to high altitude and sex
Time Frame: immediately after the evaluation
|
determine if there is a relationship between oxygen saturationas % (pulse oximeter included in the biometric station) and sex (self-reported in automated questionnaire included in the biometric station software and created ad hoc by research team) following acute exposure to high altitude
|
immediately after the evaluation
|
relationship between oxygen saturation after acute exposure to high altitude and heart rate
Time Frame: immediately after the evaluation
|
determine if there is a relationship between oxygen saturation % (pulse oximeter included in the biometric station) and heart rate (pulse oximeter included in the biometric station) following acute exposure to high altitude
|
immediately after the evaluation
|
relationship between oxygen saturation after acute exposure to high altitude and blood pressure
Time Frame: immediately after the evaluation
|
determine if there is a relationship between oxygen saturation (pulse oximeter included in the biometric station) and blood pressure (automatic wrist pressure cuff included in the biometric station) following acute exposure to high altitude
|
immediately after the evaluation
|
relationship between oxygen saturation after acute exposure to high altitude and BMI
Time Frame: immediately after the evaluation
|
determine if there is a relationship between oxygen saturation (pulse oximeter included in the biometric station) and body mass index (calculated from height (laser height meter) and weight (scale platform)) following acute exposure to high altitude
|
immediately after the evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
study the delta of oxygen saturation introduced by acute exposure to high altitude
Time Frame: immediately after the evaluation
|
study the delta of oxygen saturation (pulse oximeter) introduced by acute exposure to high altitude (differences in this variable in the transition between the downstream and the upstream measuring station)
|
immediately after the evaluation
|
study the delta of heart rate introduced by acute exposure to high altitude
Time Frame: immediately after the evaluation
|
study the delta of heart rate (pulse oximeter) introduced by acute exposure to high altitude (differences in this variable in the transition between the downstream and the upstream measuring station)
|
immediately after the evaluation
|
study the delta of blood pressure introduced by acute exposure to high altitude
Time Frame: immediately after the evaluation
|
study the delta of blood pressure (automatic wrist pressure cuff) introduced by acute exposure to high altitude (differences in this variable in the transition between the downstream and the upstream measuring station)
|
immediately after the evaluation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Piergiuseppe Agostoni, Prof, Centro Cardiologico Monzino
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- CCM 1229
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.
Clinical Trials on High Altitude Effects
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...Completed
-
United States Army Research Institute of Environmental...Eastern Michigan UniversityCompletedWeight Loss | Other Effects of High AltitudeUnited States
-
University of WaterlooWilderness Medical SocietyCompletedHigh Altitude EffectsCanada
-
United States Army Research Institute of Environmental...TerminatedHypoxia | Inadequate or Impaired Breathing Pattern or Ventilation | Effects of High Altitude | Abnormal Blood Oxygen PressureUnited States
-
Société Française de CardiologieCompletedAltitude Intolerance | High-Altitude IllnessFrance
-
Giresun UniversityNot yet recruitingPregnant | High Altitude
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityCompletedHigh Altitude RetinopathyChina
-
Third Military Medical UniversityRecruiting
-
IU University of Applied SciencesUniversity of Bologna; DLR German Aerospace Center; University of Lorraine; European... and other collaboratorsEnrolling by invitationHealthy Adults | Isolation, Social | High AltitudeGermany
-
Capital Medical UniversityNot yet recruiting