| CTRI Number |
CTRI/2015/02/005552 [Registered on: 18/02/2015] Trial Registered Prospectively |
| Last Modified On: |
27/12/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two techniques for putting cannula for measurement of blood pressure by ultrasound |
|
Scientific Title of Study
|
A comparison of two techniques for ultrasound guided cannulation of radial artery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sameer Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh |
| Address |
Department of Anaesthesia,4th Floor,
Nehru Hospital,Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
sameersethi29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh |
| Address |
Department of Anaesthesia,4th Floor,
Nehru Hospital,Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
sameersethi29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Sethi |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh |
| Address |
Department of Anaesthesia,4th Floor,
Nehru Hospital,Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
sameersethi29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia, 4th Floor, Nehru Hospital, PGIMER, Chandigarh |
| 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 |
| Dr Sameer Sethi |
Department of Anaesthesia |
4th Floor, Nehru Hospital, PGIMER,Sector 12
Chandigarh
CHANDIGARH |
9317851002
sameersethi29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,PGIMER,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I to III otherwise healthy patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Long axis in plane(LAIP) technique
of radial artery cannulation |
Long axis in plane(LAIP) technique
of radial artery cannulation |
| Comparator Agent |
SAOP VS LAIP Technique |
SAOP VS LAIP Technique |
| Intervention |
Short axis out of plane (SAOP) Technique of radial artery cannulation |
Short axis out of plane (SAOP) Technique of radial artery cannulation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included in the study:
Age group of 18-70 years
ASA physical status I-III
Weight between 40-90 Kgs
Those scheduled for elective major gastrointestinal surgical procedures needing tracheal intubation. |
|
| ExclusionCriteria |
| Details |
The patients with a negative Allen test, ulnar artery occlusion, prevalent atherosclerosis, hemorrhagic shock, morbid obesity, Raynaud disease, peripheral vascular disease and coagulation disorders will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective of this study is to compare the success rate on the first attempt of radial artery cannulation in the SA-OOP technique with the LA-IP technique. |
After induction and before start of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is to compare the ultrasonic location time, cannulation time, and the complications that will occur during arterial cannulation between the 2 techniques.
|
After induction and before start of surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2015 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The recent use of ultrasound guidance for radial artery cannulation has been shown to increase the rate of cannula insertion success at the first attempt and has consequently become widely used in radial artery examinations and cannulations.1,4–6 There are 2 basic approaches in needling techniques: short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques.7–9 In the SA-OOP approach, the transducer is oriented transversely to the vessel, and the vessel appears as a circular anechoic structure. In the LA-IP approach, a longitudinal view of the artery is obtained, and the artery appears as a tubular anechoic structure.10
The study by Berk et al showed that rate of cannula insertion success at the first attempt as 51% and 76% with the use of SA-OOP or LA-IP, respectively while Quan et al showed that the cannula insertion success rate on the first attempt was significantly higher in the modified SA-OOP group compared with the LA-IP group (proportion difference 15.7%)
Therefore the primary objective of this study is to compare the success rate on the first attempt of radial artery cannulation in the SA-OOP technique with the LA-IP technique. The secondary objective is to compare the ultrasonic location time, cannulation time, and the complications that will occur during arterial cannulation between the 2 techniques. |