| CTRI Number |
CTRI/2022/05/042404 [Registered on: 06/05/2022] Trial Registered Prospectively |
| Last Modified On: |
14/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
effectiveness of Oxygen therapies |
|
Scientific Title of Study
|
An experimental study to assess the effectiveness of oxygen therapy using split oxygen versus face mask on oxygen saturation among post operative cardiac patients bangalore |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod |
| Designation |
Nurse Practitioner |
| Affiliation |
Narayana Hrudayalaya college of Nursing |
| Address |
Narayana Hrudayalaya college of nursing,258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
kitthaganahalli Bengaluru Karnataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
7051300539 |
| Fax |
|
| Email |
sam.sandhuchitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puvaneswari k |
| Designation |
Professor |
| Affiliation |
Narayana Hrudayalaya college of Nursing |
| Address |
Narayana Hrudayalaya college of nursing,258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9448126938 |
| Fax |
|
| Email |
puvaneswari.k.k@hrudayalayafoundation.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puvaneswari k |
| Designation |
Professor |
| Affiliation |
Narayana Hrudayalaya college of Nursing |
| Address |
Narayana Hrudayalaya college of nursing,258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9448126938 |
| Fax |
|
| Email |
puvaneswari.k.k@hrudayalayafoundation.org |
|
|
Source of Monetary or Material Support
|
| Narayana Institute Of Cardiac Science Bommasandra Industrial Area Hosur Road, bangalore |
|
|
Primary Sponsor
|
| Name |
Pramod |
| Address |
Narayana Hrudayalaya college of nursing,258/A, Hosur Rd, Bommasandra Industrial Area, Bengaluru, Karnataka 560099 |
| 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 |
| Pramod |
Narayana Institute Of Cardiac Science Bommasandra Industrial Area Hosur Road Bangalore |
AITU Department Narayana Institute Of Cardiac Science Bommasandra Industrial Area Hosur Road, bangalore
Bangalore
KARNATAKA |
7051300539
sam.sandhuchitra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana health academic ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
split oxygen therapy |
an experimental study for 1 hour with split oxygen 8L on post extubation patients |
| Comparator Agent |
face mask oxygen therapy |
an experimental study for 1 hour with face mask 8L On post extubation patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate
Subjects age above 20 years |
|
| ExclusionCriteria |
| Details |
Subjects who receive sedations
subjects who had complaints of dyspnea |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine effectiveness of split oxygen therapy on oxygen saturation compared with the face mask oxygen therapy among postcardiac surgery patients. |
0 to 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To associate the oxygen saturation with the demographic and clinical variables. |
0 to 3 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/04/2022 |
| 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="3"
Days="15" |
|
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 - NO
|
|
Brief Summary
|
An experimental study to assess the effectiveness of oxygen therapy using split oxygen versus face mask on oxygen saturation among post operative cardiac patients bangalore. In this study the researcher will assess the effectiveness of split oxygen therapy and the researcher believes that split oxygen improves oxygen saturation among patients. |