| CTRI Number |
CTRI/2024/05/066896 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reason for pain after insertion of fluid giving line line into the blood vessel |
|
Scientific Title of Study
|
Thrombophlebitis following peripheral intravenous cannulation in post-operative patients – A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hari Haran R |
| Designation |
Post Graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT technology, K S Hegde Medical Academy, Nithyananda Nagar, Deralakatte post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7411113249 |
| Fax |
|
| Email |
hariharan4259@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ananda Bangera |
| Designation |
Professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesiology, Justice K S Hegde Charitable Hospital, Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9845278880 |
| Fax |
|
| Email |
ananda@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Hari Haran R |
| Designation |
Post graduate |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT technology, K S Hegde Medical Academy, Nithyananda Nagar, Deralakatte post, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7411113249 |
| Fax |
|
| Email |
hariharan4259@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Nithyananda Nagar, Deralakatte, Mangaluru - 575018 |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Nithyananda Nagar, Deralakatte, Mangaluru - 575018 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Prof Dr Ananda Bangera |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9845278880
ananda@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All electively posted cases for surgery,
Adult patients of age more than or equal to 18 years |
|
| ExclusionCriteria |
| Details |
Unconscious patients, disoriented patients, Patients with simultaneous multiple IV cannula insertions, Patients with pre-existing skin diseases and burns patients, Patients with history of allergy to any medications, Patient with blood coagulopathies, Patients who come to hospital with cannula insitu |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the factors determining the occurrence of thrombophlebitis |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the association of thrombophlebitis on patient’s morbidities and hospital stay. |
3 days |
|
|
Target Sample Size
|
Total Sample Size="366"
Sample Size from India="366"
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)
|
17/05/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multiple factors are responsible for thrombophlebitis in post-surgical patients even with the standard care. The purpose of this study is to observe and identify the various factors determining the occurrence of thrombophlebitis in post operative patients and thus to prevent these complications. |