CTRI Number |
CTRI/2018/01/011390 [Registered on: 18/01/2018] Trial Registered Retrospectively |
Last Modified On: |
16/01/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A clinical trial to compare two different arm positions on success of inserting venous catheter in to major vein seen below collar bone namely subclavian vein with ultrasound guidance in patients with artificial ventilation |
Scientific Title of Study
|
A Randomised comparison of Ultrasound guided Subclavian Vein cannulation in two
different arm positions |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
PG DISSERTATION/2015/10/20 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Indu K |
Designation |
Post Graduate |
Affiliation |
MGMCRI |
Address |
Department of Anaesthesiology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry PONDICHERRY 607402 India |
Phone |
8056900322 |
Fax |
04132615457 |
Email |
indukula@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sivashanmugam T |
Designation |
HOD |
Affiliation |
MGMCRI |
Address |
Department of Anaesthesiology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry PONDICHERRY 607402 India |
Phone |
9442505567 |
Fax |
04132615457 |
Email |
drsiva95@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Jaya V |
Designation |
Assistant Professor |
Affiliation |
MGMCRI |
Address |
Department of Anaesthesiology,
Mahatma Gandhi Medical College and Research Institute
Pondicherry PONDICHERRY 607402 India |
Phone |
9843804054 |
Fax |
04132615457 |
Email |
jayav@mgmcri.ac.in |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology, Mahatma Gandhi Medical College and Research
Institute, Pillayarkuppam, Pondicherry |
|
Primary Sponsor
|
Name |
Department of Anesthesiology |
Address |
Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam, Pondicherry - 607 403, |
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 |
Dr Indu K |
Mahatma Gandhi Medical College and Research Institute |
OT No.4-10, Operation Theatre Complex, Second floor, Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute
Pillaiyarkuppam, Pondicherry - 607 403, Pondicherry PONDICHERRY |
8056900322 04132615457 indukula@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
patients undergoing major surgeries under general anaesthesia with mechanical ventilation and requiring central venous cannulation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Group A |
Phase 1- Size, Depth and distance to Pleura/rib of SCV in point A (medial most point of ultrasonic visualisation of SCV near clavicular acoustic shadow in adducted arm position), Point A1 (Point A with abducted arm position) and Point B (medial most point of ultrasonic visualised SCV near clavicular acoustic shadow).
Phase 2- ultrasound guided Subclavian vein cannulation in adducted arm position in Point A
|
Intervention |
Group B |
Phase 1- Size, Depth and distance to Pleura/rib of SCV in point A (medial most point of ultrasonic visualisation of SCV near clavicular acoustic shadow in adducted arm position), Point A1 (Point A with abducted arm position) and Point B (medial most point of ultrasonic visualised SCV near clavicular acoustic shadow).
Phase 2 -Ultrasound guided subclavian Vein cannulation in abducted arm position in point B position |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA 1- 3 patients undergoing major surgeries under general anaesthesia with mechanical Ventilation requiring central venous cannulation |
|
ExclusionCriteria |
Details |
Depth of subclavian vein from skin is above 4 cm and patients with fracture clavicle, bleeding disorders. coagulopathy, infection at the site of cannulation and underlying lung pathologies like haemothorax,
pneumothorax. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Phase 1 -Depth of SCV
Phase 2 -First Pass Success Rate |
Phase 1- During precannulation Sonographic measurement
Phase 2- During Cannulation |
|
Secondary Outcome
|
Outcome |
TimePoints |
Phase 1-Size of the vein |
During precannulation Sonographic Measurements |
Phase 1- Distance to pleura/rib |
During precannulation Sonographic measurements |
Phase 1- Distance of Clavicle movement |
During precannulation Sonographic measurements |
Phase 1- Point A-B |
During Precannulation Sonographic measurements |
Phase 2- Failure rate |
During cannulation of SCV |
Phase 2 - No.of attempts |
During cannulation of SCV |
Phase 2-Guidewire malposition |
During Cannulation Of SCV |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
Date of First Enrollment (India)
|
01/01/2016 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Not yet published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a prospective randomized controlled trial to compare the influence of arm position on ultrasound guided subclavian vein cannulation in mechanically ventilated patients. Clavicular acoustic shadow prevents ultrasonic visualisation of Subclavian vein medially and prevent us to use ultrasound guided cannulation. Recently studies have shown in volunteers that abduction of arm moves the clavicle cephalad and may allow us to scan and puncture more medial part of subclavian vein than adducted arm position. Hence we decided to compare the dynamics and ease of of subclavian vein cannulation under ultrasound guidance in two different arm positions namely arm by the side of the body(adducted arm) and abduction of arm by 90° at shoulder joint and flexion at elbow. After standard induction, intubation and initiation of mechanical ventilation, patients were positioned in supine with arm adducted position and head turned to contralateral side. High frequency linear array transducer (HFL 50) and Sonosite Xporte machine was used. USG probe was aligned in sagittal plane to obtain the short axis view of the SCV in the lateral part of right chest just below the clavicle.Then the subclavian vein was scanned medially till the subclavian artery(SCA) disappear under the clavicular acoustic shadow and the vein was just close to that shadow. This point was marked as Point A in the skin and the sonographic image was saved.Then the arm was positioned in 900 abductions at shoulder and flexion at elbow joint and the probe was placed longitudinally at the previous Point A marked on the skin and the sonographic image was saved here as Point A1. Distance from clavicular acoustic shadow to SCV for cephalic movement at Point A1. Then the probe was moved medially until the disappearance of subclavian artery and the subclavian vein seen as close as to the clavicular acoustic shadow. This point was marked as Point B and the image was saved. The distance between Point A to Point B on the skin was measured using scale. From the saved images, Distance from skin to anterior wall of the Vein, Distance from posterior wall to pleura or rib and Size of SCV (Maximum vertical diameter, Maximum transverse diameter, Area, Circumference) all were measured by activating the software in the USG machine.After obtaining sonographic measurements, According to the Randomized allocated group, the subclavian cannulation was done using Seldinger’s technique. While inserting the guidewire, IJV was scanned to know the malposition of guidewire to IJV, it was noted and cannulated after redirecting into right atrium. First pass success was defined as the blood aspirate and successful guide wire placement in first attempt. Attempt was defined as change of needle puncture on the skin and maximum of three attempts were allowed in that allocated arm position. .Failure was defined as more than three number of attempts in that allocated group.If venous puncture was unsuccessful for three attempts, the position of arm was changed to other position and if cannulation was still unsuccessful in both the arm positions, Internal Jugular vein was cannulated under USG guidance for central venous access. Complications like arterial puncture, pneumothorax were noted and Chest X-ray was taken postoperatively to confirm the catheter tip position and if any complications, appropriate measures were taken. |