Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude

NCT05769140 | Recruiting

• 1 other identifier: CCM 1229
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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 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).

Conditions

High Altitude Effects

Outcome Measures

Primary Outcomes (5)

• relationship between oxygen saturation after acute exposure to high altitude and age

  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

  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

  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

  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

  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 Outcomes (3)

• study the delta of oxygen saturation introduced by acute exposure to high altitude

  immediately after the evaluation

• study the delta of heart rate introduced by acute exposure to high altitude

  immediately after the evaluation

• study the delta of blood pressure introduced by acute exposure to high altitude

  immediately after the evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive volunteer subjects accessing the Skyway Monte Bianco cableway and stopping to take measurements at the two biometric multiparametric recording systems Keito K9

You may qualify if:

• Age ≥ 18 years

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Skyway Monte Bianco: collaborator

Study Sites (1)

Skyway Monte Bianco

Courmayeur, Aosta, 11013, Italy

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Piergiuseppe Agostoni, Prof

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piergiuseppe Agostoni, Prof

CONTACT

+39 0258002772; piergiuseppe.agostoni@ccfm.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: March 25, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)