| CTRI Number |
CTRI/2020/08/027199 [Registered on: 18/08/2020] Trial Registered Prospectively |
| Last Modified On: |
18/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Ultrasound versus Palpatory method for posterior tibial artery cannulation |
|
Scientific Title of Study
|
Comparison of Ultrasound guided versus Palpatory method of posterior tibial artery cannulation: A prospective, Randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jhansi Eda |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology, AIIMS, Rishikesh |
| Address |
Department of Anaesthesiology Level 6 Medical College Building
AIIMS Rishikesh PIN 249203
Department of Anaesthesiology Level 6 Medical College Building
AIIMS Rishikesh PIN 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9652717362 |
| Fax |
|
| Email |
jhansiraoeda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRIYANKA GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY, AIIMS, RISHIKESH |
| Address |
Department of Anaesthesiology Level 6 Medical College Building
AIIMS Rishikesh PIN 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRIYANKA GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
DEPARTMENT OF ANESTHESIOLOGY, AIIMS, RISHIKESH |
| Address |
Department of Anaesthesiology Level 6 Medical College Building
AIIMS Rishikesh PIN 249203
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
VEERBHADRA ROAD, 249201 |
| 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 PRIYANKA GUPTA |
AIIMS Rishikesh |
Department of
Anaesthesiology 6th
floor Virbhadra Marg
Pashulok Rishikesh
Dehradun
UTTARANCHAL |
9811894899
drpriyankagupta84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparison of Ultrasound guided versus Palpatory method of posterior tibial artery cannulation |
After induction of general anesthesia, all aseptic precautions will be taken and a 20G arterial cannula will be used to percutaneously puncture the PTA either by the palpation technique in the groove between the medial malleolus and tendon of Achilles or by the USG- guided technique using a linear probe transducer and real time visualization of artery. |
| Comparator Agent |
Palpatory Method |
Catheter over needle technique will be performed in which after making position of lower limb as described above, under strict aseptic precaution the posterior tibial artery will be palpated with nondominant hand finger in groove between medial malleolus and tendon of Achilles. At the point of maximum arterial pulsation, arterial cannula will be inserted at 45 degrees and after confirmation of backflow of arterial flash stylet will be slightly removed, angle of cannula decreases and catheter will be slide over stylet to complete cannulation |
| Comparator Agent |
USG guided Technique |
After making limb position (ankle dorsiflexion up to 90 degrees and eversion of the foot), the ultrasound linear probe (12 MHz of GE-logiq, GE health care) footprint will be covered with conduction gel, covered in sterile cover and placed where arterial pulsations were most prominent near the groove between the medial malleolus and tendo Achilles.
After viewing the artery in cross section, the transducer will be rotated 90°, keeping the image in the center of the ultrasound screen to identify the artery in its long axis. When the artery appeared as a tubular anechoic structure, a 20-G needle will be inserted with bevel-up orientation at about 30 to 45° to the skin and parallel to the transducer directly under the center of the transducer. The needle and artery will both visualized entirely within the plane of ultrasound imaging. After confirming the needle tip within the lumen and the arterial blood flashback in the needle hub, the angle of the needle will be lowered and gently advanced slightly more distally under ultrasound guidance. After arterial blood flashback, the stylet will be slightly removed and the arterial catheter will be advanced further for complete cannulation. Diameter of artery will be measured both pre and post procedure in horizontal section
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I - IV
Patients undergoing major surgeries requiring arterial cannulation |
|
| ExclusionCriteria |
| Details |
1.Patient refusal to consent.
2.Patient with absence of arterial pulsation.
3.Skin erosions near the insertion site.
4.Patient undergoing surgery on lower limbs.
5.Patients with peripheral vascular disease.
|
|
|
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 |
To compare the success rate of ultrasound guided versus conventional Palpatory method of posterior tibial artery cannulation for first time successful cannulation.
|
This is not applicable as single reading will be taken at the time of intra arterial cannulation.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the number of attempts.
2. To compare the assessment time.
3. To compare the cannulation time.
4. To compare Cannulation failure.
5. To compare the complication with multiple attempts like spasm, thrombosis, necrosis.
|
This is not applicable as single time reading will be taken at the time of intra arterial cannulation.
|
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
20/08/2020 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
Intra-arterial
cannulation, a frequently used method for continuous beat to beat blood
pressure monitoring, assessing fluid response, arterial blood gas analysis and
frequent blood sampling in the intraoperative period in major surgeries as well
as in the intensive care unit.Posterior tibial
artery has larger diameter and has extensive collateral circulation. It has
been shown that cannulation of posterior tibial artery is comparable to radial
artery cannulation and even better than the dorsalis pedis artery cannulation.Hypothesis:We hypothesize that ultrasound guided posterior
artery cannulation will be better than conventional Palpatory technique with
respect to first attempt success rates and decreasing the number of attempts.
Aim:Our aim is to compare Palpatory versus ultrasound guided posterior
tibial artery cannulation with respect to first attempt success rates and
decreasing the number of attempts. Objective:To compare the success rate of ultrasound guided versus conventional Palpatory
method of posterior tibial artery cannulation for first time successful
cannulation. Material and Methods: A Prospective,
randomized controlled study Sample size and Statistics: 120 patients in each groups. |