| CTRI Number |
CTRI/2025/07/091187 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the usefulness of an intravenous access scale to predict difficult venous cannulation in the South - Indian population |
|
Scientific Title of Study
|
Prognostic accuracy of the A- DIVA scale to predict difficult intravenous access in a tertiary care hospital in southern India- 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 |
Dr KARTHIKA BABU |
| Designation |
Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 211, Department of Anaesthesiology, second floor, Hospital block, Mahatma Gandhi medical college and Research Institute PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
07598425969 |
| Fax |
|
| Email |
karthigaalagu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charulatha R |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 211, Department of Anaesthesiology, second floor, Hospital block, Mahatma Gandhi medical college and Research Institute PONDICHERRY, India, 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KARTHIKA BABU |
| Designation |
Postgraduate |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Room no 211, Department of Anaesthesiology, second floor, Hospital block, Mahatma Gandhi medical college and Research Institute PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
07598425969 |
| Fax |
|
| Email |
karthigaalagu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute, Pondicherry Cuddalore Road, ECR, Pillayarkuppam, Puducherry, India, 607402 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Pondicherry Cuddalore road, ECR Puducherry |
| 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 |
| Dr Karthika Babu |
Mahatma Gandhi Medical College and Research Institute |
Room number 211, Department of Anesthesiology, Second floor, Hospital block
Pondicherry
PONDICHERRY |
07598425969
karthigaalagu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, Mahatma Gandhi Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1-4 physical status |
|
| ExclusionCriteria |
| Details |
1. Patient who cannot answer the history of prior difficult intravenous cannulation due to cognitive or communication disabilities.
2.Prior intraveous access has been obtained in the ward. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Failed peripheral intravenous cannulation in the first attempt. |
5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts |
5 minutes |
| Size of the applied catheter |
5 minutes |
| Reason for failed attempts |
15 minutes |
| Reason for second line device |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="765"
Sample Size from India="765"
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)
|
15/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [karthigaalagu@gmail.com].
- For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study titled "Prognostic Accuracy of the A-DIVA Scale to Predict Difficult Intravenous Access in a Tertiary Care Teaching Hospital in Southern India" is a prospective observational study conducted at Mahatma Gandhi Medical College and Research Institute, Puducherry. It aims to evaluate the sensitivity and specificity of the Adult Difficult Intravenous Access (A-DIVA) scale in predicting first-attempt peripheral intravenous cannulation failure in surgical patients. The study includes adult patients undergoing elective or emergency surgeries, using consecutive sampling and informed consent. The A-DIVA scale, comprising five clinical predictors, will be applied in the preoperative setting, and outcomes such as cannulation success, number of attempts, and associated risk factors will be documented. With a calculated sample size of 765, the study intends to validate the A-DIVA scale’s prognostic accuracy in the local population and promote early identification of patients requiring alternative access strategies, such as ultrasound guidance, thereby improving patient safety and procedural efficiency |