| CTRI Number |
CTRI/2016/12/007534 [Registered on: 05/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of two different methods of radial artery cannulation in patients posted for emergency surgery |
|
Scientific Title of Study
|
Comparison of direct and guide-wire assisted techniques of radial artery cannulation in patients posted for emergency surgery- a randomized 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 |
N C Pankaj Kumar |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Anesthesiology and Critical Care, JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
|
| Fax |
|
| Email |
pankaj.chakri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
N C Pankaj Kumar |
| Designation |
Junior Resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Anesthesiology and Critical Care, JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
|
| Fax |
|
| Email |
pankaj.chakri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
A Vasudevan |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Anesthesiology and Critical Care, JIPMER
Pondicherry PONDICHERRY 605006 India |
| Phone |
|
| Fax |
|
| Email |
jipmervasu@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Institute Fund, JIPMER, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER, PONDICHERRY, INDIA - 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| N C PANKAJ KUMAR |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Emergency Operation Theater, 2nd floor, EMS and Trauma center, JIPMER, Pondicherry, INDIA- 605006 Pondicherry PONDICHERRY |
8098030880
pankaj.chakri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, Patients posted for emergency surgery in whom arterial blood pressure monitoring and arterial blood gas analysis is required, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group C |
Radial artery cannulation with arterial cannula. |
| Comparator Agent |
Group G |
Radial artery cannulation with arterial guide-wire catheter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender, presenting with
emergency surgical conditions requiring invasive blood pressure monitoring or frequent arterial blood gas measurements.
|
|
| ExclusionCriteria |
| Details |
1. Patients with inadequate ulnar collateral
circulation identified by performing modified Allen’s test.
2. Patients/patient surrogates who don’t give valid informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare success rate of cannulation on first attempt between the two techniques.
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Number of attempts taken for cannulation between the two techniques. |
18 months |
| 2. Time taken for a successful cannulation between the two techniques. |
18 months |
3. Overall success rate of cannulation with the two techniques.
|
18 months |
|
|
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)
|
05/05/2014 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Invasive arterial pressure
monitoring and frequent blood gas analysis have become essential components for
physiologic optimization and anesthesia management of emergency surgical procedures
in patients presenting with major blood loss or sepsis. Radial artery is used
commonly for cannulation as it is easily accessible and associated with less
incidence of post-cannulation complications (1). Various techniques exist for
arterial cannulation like the direct over-the-needle cannulation(2,3,4),
guide-wire assisted catheterization(2,3,4), liquid stylet technique(5), and
ultrasound-guided catheterization(6).
Previous studies have shown that
radial artery cannulation with guide-wire assistance was more successful
compared to the direct technique in patients undergoing various cardiovascular
and neurosurgical procedures in the elective set-up, done by staff anesthesiologists
(3, 4). In the emergency surgical suite the arterial cannulations are mostly done
by residents with limited experience and the direct cannulation is the most
common technique employed. However the direct cannulation technique may be
difficult in patients with low arterial pressure, requiring multiple attempts
and causing considerable delay. The purpose of this study is to assess whether arterial
cannulation can be achieved faster, with fewer attempts, using the guide-wire
assisted technique. |