Skyway Monte Bianco
Courmayeur, Aosta, 11013, Italy
Location status: Recruiting
NCT Number: NCT05769140
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Courmayeur, Aosta, 11013, Italy
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
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)
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)
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)
Contact information is provided by the study sponsor or research team.
Centro Cardiologico Monzino
Other
Measurement of Cardiopulmonary Variables in a Large Group of Healthy Subjects with Acute Exposure to High Altitude
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