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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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