| CTRI Number |
CTRI/2019/12/022349 [Registered on: 12/12/2019] Trial Registered Prospectively |
| Last Modified On: |
07/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of two ultrasound guided central line insertion techniques |
|
Scientific Title of Study
|
Comparison of conventional technique and pen holding technique for real time ultrasound guided internal jugular venous cannulation – A prospective randomized controlled trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRINIVASAN R |
| Designation |
ASST PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE HOSPITAL |
| Address |
SECOND FLOOR
DEPARTMENT OF ANESTHESIOLOGY
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE
KALITHEERTHALKUPAM
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9940394386 |
| Fax |
|
| Email |
drsrini16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SRINIVASAN R |
| Designation |
ASST PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE HOSPITAL |
| Address |
SECOND FLOOR
DEPARTMENT OF ANESTHESIOLOGY
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE
KALITHEERTHALKUPAM
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9940394386 |
| Fax |
|
| Email |
drsrini16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRINIVASAN R |
| Designation |
ASST PROFESSOR |
| Affiliation |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE HOSPITAL |
| Address |
SECOND FLOOR
DEPARTMENT OF ANESTHESIOLOGY
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE
KALITHEERTHALKUPAM
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9940394386 |
| Fax |
|
| Email |
drsrini16@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE RESEARCH FUND
SMVMCH
KALITHEERTHALKUPPAM
MADAGADIPET
PONDICHERRY
|
|
|
Primary Sponsor
|
| Name |
SMVMCH RESEARCH FUND |
| Address |
SMVMCH
KALITHEERTHALKUPPAM
MADAGADIPET
PONDICHERRY |
| 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 |
| SRINIVASAN |
SRI MANAKULA VINAYAGAR MEDICAL COLLEGE HOSPITAL HOSPITAL |
SECOND FLOOR
CLINICAL DEPARTMENT HOSPITAL BLOCK
SRI MANAKULA VINAYAGAR MEDICAL HOSPITAL
Kalitheerthalkuppam, Madagadipet, Puducherry, 605107
Pondicherry
PONDICHERRY |
9940394386
drsrini16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional ultrasound guided internal jugular venous cannulation technique |
group will be cannulated by convention real time ultrasound guided technique. |
| Comparator Agent |
pen holding method of ultrasound guided internal jugular venous cannulation technique |
group will be cannulated by pen holding method of real time ultrasound guided technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Adult patients of either gender between 18 and 70 years of age
b) Belonging to the American Society of Anesthesiologists Physical Status I–III
c) Undergoing general anesthesia and requiring USG guided IJV cannulation
|
|
| ExclusionCriteria |
| Details |
a) Patients with untreated coagulopathy, known vascular abnormalities,
b) Skeletal abnormalities (e.g., cervical spine disorders),
c) Previous surgery over neck area, existing thyroid or neck swelling, localized neck infection
d) Any history of neck surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of posterior vessel wall puncture and the successful IJV cannulation in first attempt |
Time taken for successful cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of complication such as arterial puncture, andperformer’s ease of the procedurein both the techniques |
during the procedure |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/12/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
ultrasound guided central venous cannulation is the standard of care. the incidence of posterior vessel wall puncture in convention ultrasound guided technique is 21% and arterial puncture is 5%. the incidence of posterior vessel wall puncture is reported to be less in penholding method, hence the chance of arterial puncture. the study is designed to compare these two techniques.
Patients will be divided into 2 groups, group C (conventional ultrasound guided technique group) and group P (penholding method group). Inside operation room, after induction of anesthesia ultrasound guided internal jugular venous cannulation will be done using one of these techniques. Incidence of posterior vessel wall puncture, successful cannulation in first attempt, and time taken for successful cannulation will be done by an independent observer not involved in the study. Also complications in both the groups and performers ease will be assessed. |