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Altitude Sickness clinical trials

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NCT ID: NCT06450899 Recruiting - Clinical trials for Acute Mountain Sickness

Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

Start date: August 2024
Phase: Phase 2
Study type: Interventional

This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).

NCT ID: NCT06393998 Recruiting - Clinical trials for Acute Mountain Sickness

CO2 Supplement for Treatment of Acute Mountain Sickness

Start date: June 7, 2024
Phase: N/A
Study type: Interventional

It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. It has also been well documented that exercise capacity was impaired at high altitude. Oxygen inhalation is the most effective treatment method, but it is impractical for outdoor activities because of the large volume required. There are some drugs such as acetazolamide, and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use. It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA. There is no available device which can accurately supply constant CO2 and is functionally free of dead space. We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS.

NCT ID: NCT06204731 Recruiting - Hypoxia, Altitude Clinical Trials

The Impact of Physical Training Under Normobaric Hypoxia on Oxidative Stress Level, Inflammatory State, Intestinal Damage, and Mitochondrial Metabolism in Young Males

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

- Cognitive assessment of the influence of a 4-week proprietary training program under normobaric hypoxia conditions on the levels of inflammatory markers, disturbances in prooxidant-antioxidant balance, degree of intestinal damage, and mitochondrial energy production rate in young sedentary males. - Applied objective: Development of practical training guidelines utilizing training in normobaric hypoxia conditions to enhance mechanisms related to oxygen transport, adaptive changes within the immune system, body's antioxidant capacity, gut permeability, substrate utilization efficiency, and mitochondrial function for coaches and athletes.

NCT ID: NCT06159374 Recruiting - Hypoxia, Altitude Clinical Trials

Effects of Physical Training in Altered Environmental Conditions on Exercise Performance

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect of training in high-performance athletes. The study will evaluate the effects of physical training and the simultaneous application of hypoxia and heat/cold on aerobic and anaerobic capacity and the physiological response of the human body. The aim of the study is to find the most favourable environmental conditions for physical training in order to maximise physical performance.

NCT ID: NCT06152744 Recruiting - Clinical trials for Extracorporeal Membrane Oxygenation

Evaluation of Membrane Lung Function in High-altitude Regions

Start date: December 5, 2023
Phase:
Study type: Observational

Over the last 20 years, extracorporeal membrane oxygenation (ECMO) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ECMO circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. The prolonged use of an ECMO circuit increases the risk of membrane lung (ML) dysfunction. The ML is responsible for taking in oxygen and removing carbon dioxide. The non-biologic surface of the ML triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ML dysfunction. Coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. Moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. These three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ML exchanges. Worsening oxygenation during ECMO should prompt quantification of oxygen transfer. ML exchange is indicated when the ML can no longer meet the patient's oxygen demand. The partial pressure of Post-ML arterial oxygen less than 200 mmHg is the most important consideration in this decision. In some high-altitude regions of China, ECMO treatment is also routinely conducted. The experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. This study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.

NCT ID: NCT06039475 Recruiting - Clinical trials for Acute Mountain Sickness

RISK FACTORS ASSOCIATED WITH HIGH ALTITUDE SICKNESS: A CASE-CONTROL STUDY

Start date: July 1, 2023
Phase:
Study type: Observational

Research Title: RISK FACTORS ASSOCIATED WITH HIGH ALTITUDE SICKNESS: A CASE-CONTROL STUDY Rationale: The Study will help us to identify risk factors of high altitude sickness among Nepalese and International patients. Aims and Objectives: - To identify risk factors for high altitude sickness, including AMS, HACE, and HAPE. - To compare the prevalence of high altitude sickness between individuals who ascended rapidly versus those who ascended slowly. - To examine the association between high altitude sickness and various demographic and environmental factors, such as age, sex, altitude, and temperature. - To evaluate the effectiveness of preventative measures, such as gradual ascent and medication, in reducing the risk of high altitude sickness Research Hypothesis (if relevant): N/A 1. Material & Methods: 1. Whether study involves Human/animals or both : Human 2. Population/ participants: Patients presenting in Emergency Ward of District Hospital, Mustang with AMS (Acute Mountain Sickness), HAPE (High altitude Pulmonary Oedema) or HACE (High altitude Cerebral Oedema) as CASES Healthy volunteers who didn't develop any symptoms of AMS/HAPE/HACE after their trip to high altitude as CONTROLS 3. Type of study design: : Case Control Study 4. Human study : Inclusion Criteria: Cases: Individuals age 18 years or older who have been diagnosed with AMS based on a LLS score of ≥3 or HAPE or HACE. Controls: Individuals age 18 years or older who did not develop AMS during their trip to high altitude as the cases, and who are matched to cases on age and sex. Exclusion Criteria: - Those who deny consent for participation. - Age<18 years - Pregnant Women 5. Expected sample size : Sample size calculation: Mentioned in methodology 6. Control groups : N/A 7. Probable duration of study: 180 days 8. Setting: Emergency Ward 9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, sex, address, nationality. Dependent Variables: i. Symptoms of Presentation ii. Ascent Rate iii. Co-morbidities iv. Past History including previous history of altitude sickness v. Personal History such as smoking, alcohol intake, recreational drugs vi. Awareness on High Altitude Sickness vii. Intake of Prophylactic medicine (Acetazolamide) viii. Past history of Covid-19 , TB Outcome measures: Primary (main outcome): All dependent variables (i) Rational for statistical methods to be employed : Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis . Descriptive statistics will be used to summarize the characteristics of cases and controls. Univariate and multivariate logistic regression analyses will be performed to assess the association between risk factors and high altitude sickness. The results will be reported as odds ratios with corresponding 95% confidence intervals. A p-value of less than 0.05 will be considered statistically significant. (ii) Ethical clearance : Ethical clearance will be obtained from National Health Research Council of Nepal (iii) Permission to use copyright questionnaire/Pro forma: Not applicable (j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes 1. Other resources needed: No 2. For Intervention trial: Not applicable

NCT ID: NCT05769140 Recruiting - Clinical trials for High Altitude Effects

Measurement of Cardiopulmonary Variables After Acute Exposure to High Altitude

Start date: March 25, 2020
Phase:
Study type: Observational

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).

NCT ID: NCT05733338 Recruiting - Clinical trials for Acute Mountain Sickness

The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This study intends to further reveal the effectiveness of intermittent hypoxia in preventing acute hypoxic injury.

NCT ID: NCT05474287 Recruiting - Hypoxia Clinical Trials

SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes

Start date: October 14, 2022
Phase: N/A
Study type: Interventional

This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.

NCT ID: NCT05304923 Recruiting - Hypoxia Clinical Trials

Supraglottic Jet Oxygenation and Ventilation for Gastrointestinal Endoscopy at High-altitude

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

This study aims to determine whether the use of SOJV could reduce the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients sedated at high altitude comparing to the supplemental oxygen administration via nasal cannula.