Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769140
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-03-03
Brief Title:
Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude
Sponsor:
Centro Cardiologico Monzino
Organization:
Centro Cardiologico Monzino
Study Overview
Official Title:
Measurement of Cardiopulmonary Variables in a Large Group of Healthy Subjects with Acute Exposure to High Altitude
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 bodys 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 3466 m above sea level a location on Mont Blanc that is readily accessible by a 20-minute cableway ride from Courmayeur Entreves station 1300 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
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 3466 m above sea level a location on Mont Blanc that is readily accessible by a 20-minute cableway ride from Courmayeur Entreves station 1300 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None