| CTRI Number |
CTRI/2023/03/050539 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two technique of insertion of invasive blood pressure monitoring with or without waveform assistance: A prospective, randomized controlled trial |
|
Scientific Title of Study
|
Evaluation of radial artery cannulation by palpation method with or without direct waveform assistance (DiWA): A prospective, randomized controlled trial |
| Trial Acronym |
DiWA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narender Kaloria |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, 4th Floor, Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Narender Kaloria |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, 4th Floor, Nehru Hospital, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Narender Kaloria |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Anaesthesia and Intensive Care, 4th Floor, Nehru Hospital, PGIMER, Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872495145 |
| Fax |
|
| Email |
naren.keli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
PGIMER, Sector 12, Chandigarh |
| Type of Sponsor |
Research institution |
|
|
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 Narender Kaloria |
OPERATION THEATRES |
Operation Theatres, Nehru Hospital, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
8872495145
naren.keli@gmail.com |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct waveform analysis |
A pressure transducer will be connected to arterial cannula with pressure monitoring line. Radial artery will be identified with palpation method and radial artery cannulation done with direct appearance of arterial waveform on the monitoring |
| Comparator Agent |
Plapation |
Here, arterial cannulation will be done by palpation of radial artery, no other aids will be used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients who require arterial cannulation under general anaesthesia for elective surgery |
|
| ExclusionCriteria |
| Details |
Refusal to participate
1. Haemodynamic instable patient
2. Body mass index >35
3. Positive modified Allen’s test for availability of collateral artery
4. History of peripheral vascular disease
5. Non-availability of radial artery such as trauma to upper limb, post CABG etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of first attempt success rate among both technique |
At the time of arterial puncture |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to successful cannulation
2. Number of re-directives
3. Number of attempts to achieve cannulation
4. Overall success/failure rate
5. Complications such as hematoma, vasospasm etc. |
At the time of arterial puncture |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
15/03/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [naren.keli@gmail.com].
- For how long will this data be available start date provided 15-03-2024 and end date provided 14-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Arterial cannulation is required in various surgeries and intensive care units for the beat to beat arterial pressure monitoring and arterial blood gas analysis. The arterial cannulation is routinely done using the palpation method where the artery is palpated and the arterial cannula is inserted. However, this method has some limitations such as less first-pass success rate, requiring a longer clinical experience and puncture site hematoma due to a lack of real-time guidance. Direct Waveform Assistance (DiWA) is a newer technique where arterial cannulation is done under direct arterial waveform guidance. Hence, this is planned to compare arterial cannulation palpation method with or without Direct Waveform Assistance (DiWA) in patient who required radial artery cannulation under general anaesthesia. The study will enroll 206 patients who will require arterial cannulation under general anaesthesia and required surgical procedure. |