| CTRI Number |
CTRI/2025/06/088104 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
using ultrasound for cannulating radial artery for invasive blood preessure monitoring in patients undergoing major surgeries compared to traditional palpatory method |
|
Scientific Title of Study
|
Effectiveness of Ultrasound as a tool for Radial artery cannulation compared to the traditional palpatory technique- A Prospective randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KADAVERU LAHARI |
| Designation |
RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, OLD BLOCK 1ST FLOOR, NIMS, PANJAGUTTA, HYDERABAD, TELANGANA
Hyderabad TELANGANA 500082 India |
| Phone |
9502876214 |
| Fax |
|
| Email |
klahari01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MONU YADAV |
| Designation |
PROFESSOR |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, OLD BLOCK 1ST FLOOR, NIMS, PANJAGUTTA
Hyderabad TELANGANA 500082 India |
| Phone |
9490213460 |
| Fax |
|
| Email |
monubalbir@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
KADAVERU LAHARI |
| Designation |
RESIDENT |
| Affiliation |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, OLD BLOCK 1ST FLOOR, NIMS, PANJAGUTTA
Hyderabad TELANGANA 500082 India |
| Phone |
9502876214 |
| Fax |
|
| Email |
klahari01@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIZAMS INSTITUTE OF MEDICAL SCIENCES, PANJAGUTTTA, HYDERABAD - 500082, TELANGANA |
|
|
Primary Sponsor
|
| Name |
NIZAMS INSTITUE OF MEDICAL SCIENCES |
| Address |
PANJAGUTTA, HYDERABAD, TELANGANA,500082 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| KADAVERU LAHARI |
NIZAMS INSTITUTE OF MEDICAL SCIENCES |
DEPT OF ANESTHESIA, OLD BLOCK, 1ST FLOOR, PANJAGUTTA , HYDERABAD, TELANGANA, 500082 Hyderabad TELANGANA |
09502876214
klahari01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I TO IV PATIENTS UNDERGOING MAJOR ELECTIVE SURGERIES |
|
| ExclusionCriteria |
| Details |
PAEDISTRIC AND PREGNANT POPULATION
PATIENT DENIAL
NEGATIVE ALLENS TEST
INFECTION AT THE SITE OF CANNULATION
EMERGENCY SURGERIES
VASCULAR MALFORMATIONS
PERIPHERAL VASCULAR DISEASE
COAGULOPATHY
PREVIOUSLY ATTEMPTED ARTERIAL CANNULATION IN THE LAST ONE WEEK |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE SUCCESS RATE OF RADIAL ARTERY CANNULATION WITH TRADITIONAL PALPATORY TECHNIQUE AND USG GUIDED TECHNIQUE IN TERMS OF THE NUMBER OF ATTEMPTS/PUNCTURE SITES.TIME TAKEN FOR SUCCEEFUL CANNULATION |
5 SECONDS, 10 SECONDS, 30 SECONDS, 1 MINUTE, 5 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE ASSOCIATED IMMEDIATE COMPLICATIONS LIKE HAEMATOMA FORMATION AND VASOSPASM WITH BOTH THE TECHNIQUES |
5 seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
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)
|
10/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/06/2025 |
| 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 - NO
|
|
Brief Summary
|
BLOOD PRESSURE MONITORING HAS BEEN A FUNDAMENTAL CARDIOVASCULAR VITAL SIGN INCLUDED IN THE STANDARD ASA MONITORING DURING THE PERIOPERATIVE PERIOD AND INTENSIVE CARE UNIT. CONTINUOUS INVASIVE ARTERIAL BLOOD PRESSURE MONITORING SURPASSESS THE NONINVASIE INTERMITTENT BLOOD PRESSURE MONITORING BY ITS ABILITY TO A GIVE A REAL TIME BLOOD PRESSURE MONITORING.ANY ANTICIPATED PHARMACOLOGIC OR MECHANICAL CARDIOVASCULAR MANIPULATION,REQUIREMENT OF FREQUENT BLLOD SAMPLING AND SUPPLEMENT THE DIAGNOSTIC INFROMATION FROM ITS ARTERIAL WAVEFORM. TRADITIONALLY THE CANNULATION HAS BEEN PERFORMED USING ANATOMIC KNOWLEDGE AND PULSE PALPATIONAS A GUIDE TO PLACEMENT.HOWEVER PATIENTS REQUIRING ARTERIAL LINES MAY BE OBESE OR EDEMATOUS OR HAVE FEEBLE PULSESECONDARY TO HYPOTENSION AND ALSO THE CATHETER MAY NOT BE PASSED SUCCESSFULLY INTO THE ARTERY DESPITE APPARENT GOOD BLOOD RETURN AFTER INITIAL PUNCTRE OR THE ARTERY MAY DEVEOP SPASM. AFTER A FAILED ATTEMPT THUS MAKING BLIND PALPATORY TECHNIQUE A DIFFICULT ONE. THIS STUDY IS AN ATTEMPT TO COMPARE THE TRADITIONAL PALPATORY TECHNIQUE WITH THE USG GUIDED TECHNIQUE IN TERMS OF CANNULATION TIME,THE NUMBER OF ATTEMPTS, CHANGE TO OTHER SITE OR ARTERY OR ALTERNATIVE PROVIDER. |