Risk Factors Associated With High Altitude Sickness: A Case-Control Study

Summary

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

Conditions

• Acute Mountain Sickness
• High Altitude Pulmonary Edema
• High Altitude Cerebral Edema

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-01

Primary Completion

2023-11-30

Completion

2023-11-30

Countries

• Nepal

Study Locations