| CTRI Number |
CTRI/2020/12/029978 [Registered on: 22/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational study |
| Study Design |
Other |
|
Public Title of Study
|
To observe and compare effects of different heights of high altitude on different group of individuals staying there for more than 6 weeks |
|
Scientific Title of Study
|
Observational study to compare the effect of altitude on cardiopulmonary reserves of different individuals staying more than 06 weeks at 10,000 ft and 15,000ft respectively |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
CH-69/3 Command Hospital Offficers Residential Accomodation
Department of Anaesthesiology and Critical Care,
2nd Floor, Command Hospital Chandimandir - Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
9612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
CH-69/3 Command Hospital Officers Residential Accomodation
Command Hospital
Chandimandir
Departmet of Anaesthesiology and Critical Care
Chandimandir - Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Singh |
| Designation |
Assistant Professor |
| Affiliation |
Command Hospital Chandimandir |
| Address |
CH-69/3 Command Hospital Oddicers Residential Accomodation
Command Hospital Chandimandir
Department of Anaesthesiology and Critical Care,
2nd Floor
Command Hospital Chandimandir, Panchkula
Panchkula
HARYANA
134107
India |
| Phone |
09612112136 |
| Fax |
|
| Email |
gunjanafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nil being observational study and government hospital. Command Hospital Chandimandir, Dist Panchkuka, State Haryana |
|
|
Primary Sponsor
|
| Name |
GUNJAN SINGH |
| Address |
COMMAND HOSPITAL |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| GUNJAN SINGH |
COMMAND HOSPITAL |
Department of Anaesthesiology and Critical Care , Second Floor
Panchkula
HARYANA |
9612112136
gunjanafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Command Hospital Western Command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
males who are free from any disease |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
Patients who are ASA I as per American Socitey of Anaesthesiology |
|
| ExclusionCriteria |
| Details |
1) Any patient below ASA I
2) History of Bronchial Asthma or any resp disease
3) History of smoking
4) Stay at these altitude of less than 6 weeks
5) History of Diabetes Mellitu and Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the opening SpO2 and then SpO2, HR before and after 6 minute walk test |
Compare the Breath Holding Time after adequate rest |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of the above mentioned parameters and divide the individuals for pulse oximetry into less than 88, 88 to 92 and more than 92percent. As far as breath holding is concerned, will divide the individual on the basis of increase in heart rate as increase more than 15 percent, between 10-15 percent and less than 10 percent
For breath holding time , group will be divided as less than 25 sec, 15-25 sec and less than 10 sec |
On the basis of breath holding time, increase in Heart Rate percentage in 6 min walk test and changes in the SpO2, categorisation into different groups will be done |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
28/12/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gunjanafmc@gmail.com].
- For how long will this data be available start date provided 12-02-2021 and end date provided 12-02-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Individuals posted at high altitudes are in continous state of hypoxemia. Newly inducted individuals,despite getting acclimatized and working at these altitudes for more than 6 weeks, continue to have fatigue and breathlessness on exertion while doing daily routine chores . With sudden surge in the population at high altitude and with sudden surge of illness, accidents and effects of war like situations it is necessary to determine the effect in change in altitude with the help of surrogate markers like SpO2, 6 minute walk test limited to Heart Rate only and Breath holding Time. This will be of great hep to assess, analyse and plan future course of action for operating the patient under such low oxygen concentration present in the atmosphere. This will also be of great help to assess that upto what extent, moderate and extreme high altitudes have any role in the anaesthestic management of acclimatized individuals |