| CTRI Number |
CTRI/2021/01/030422 [Registered on: 13/01/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to understand the effects of high altitude regions on the heart and lungs of healthy individuals. |
|
Scientific Title of Study
|
Observational study to assess the effect of extreme high altitude on cardiopulmonary reserves of individuals staying more than 6 weeks from Anaesthesiologist’s perspective. |
| Trial Acronym |
CRHAA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lt Col Gunjan Singh |
| Designation |
Paediatric Anaesthesiologist |
| Affiliation |
Command Hospital (Western Command), Chandimandir |
| Address |
Department Of Anaesthesiology and Critical Care, Command Hospital (Western Command), Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Gunjan Singh |
| Designation |
Paediatric Anaesthesiologist |
| Affiliation |
Command Hospital (Western Command), Chandimandir |
| Address |
Department Of Anaesthesiology and Critical Care, Command Hospital (Western Command), Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lt Col Gunjan Singh |
| Designation |
Paediatric Anaesthesiologist |
| Affiliation |
Command Hospital (Western Command), Chandimandir |
| Address |
Department Of Anaesthesiology and Critical Care, Command Hospital (Western Command), Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital (Western Command)
Chandimandir, Panchkula |
|
|
Primary Sponsor
|
| Name |
Command Hospital WC Chandimandir Panchkula |
| Address |
Department Of Anaesthesiology and Critical Care, Command Hospital (Western Command), Chandimandir, Panchkula, Haryana, Pin-134107. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Lt Col Vipin Sukumaran |
Department Of Anaesthesiology and Critical Care, Command Hospital (Westen Command), Chandimandir, Panchkula, Haryana, Pin-134107. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Lt Col Gunjan singh |
Command Hospital (WC), Chandimandir, Panchkula |
Department of Anaesthesiology and critical care,Near operation theatre, Panchkula, Haryana, pin-134107
Panchkula
HARYANA |
09612112136
gunjanafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital (Western Command), Chandimandir |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1. Individuals between 17 yrs and 55 yrs of age
2.ASA I individuals |
|
| ExclusionCriteria |
| Details |
1. Any patients below ASA I
2. History of bronchial asthma, or any respiratory disease.
3. History of smoking
4. Stay at moderate and extreme high altitudes less than 6 weeks
5. History of Diabetes Mellitus, Hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of variability of SPO2, Heart rate and Breath holding time after 6 minute walk test. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Categorization of healthy volunteers in to Mild, moderate & severe groups on the basis of SPO2, Heart rate and Breath holding time. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study to find out the effect of extreme high altitude on cardiopulmonary reserves of individuals staying more than 6 weeks in high altitudes. Patients will be observed depending on oxygen saturation by SPO2 monitoring, Changes in heart rate by 6 min walk test and Breath holding time. This will help to assess the number of individuals who can tolerate high altitude without serious health issues. It will also help us to assess the effect of high altitude in the anaesthetic management of individuals. |