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CTRI Number  CTRI/2024/10/074562 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the number of days and device utility between two intravenous canula in patients undergoing surgery 
Scientific Title of Study   Efficacy of long peripheral catheter (LPC) versus peripheral intravenous cannula (PIVC) for perioperative vascular access in high risk surgical patients - a randomised comparative trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddharth Chandanamuthu 
Designation  Postgraduate 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Room no:211,Department of Anaesthesiology, Second floor, Hospital Block Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9894583209  
Fax    
Email  siddharth_chandan@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sivashanmugam T 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Room no:211,Department of Anaesthesiology, Second floor, Hospital Block Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9442505567  
Fax    
Email  drsiva95@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sivashanmugam T 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Room no:211,Department of Anaesthesiology, Second floor, Hospital Block Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9442505567  
Fax    
Email  drsiva95@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute , Pondicherry cuddalore road , ECR , Puducherry 607402 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute , Pondicherry 
Address  Pondicherry Cuddalore road , ECR , Puducherry 607402 
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 Siddharth Chandanamuthu  Mahatma Gandhi Medical College and Research Institute  Room no :211,Department of Anaesthesiology Second floor, Hospital Block.
Pondicherry
PONDICHERRY 		 9894583209

siddharth_chandan@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LONG PERIPHERAL CATHETER PLACEMENT  Patients allocated to Group LPC will be shifted to the procedure room in the operating theatre complex. The appropriate vein basilic or brachial will be chosen adhering to Rapid Peripheral Vein Assessment Protocol and with a catheter vessel ratio of less than 30 %. An 18 G 9.2 cm Long peripheral catheter will be inserted according to the SIP protocol using the Seldinger technique. Anesthesiologists with at least two years of experience in ultrasound guided vascular access will insert all the catheters 
Comparator Agent  PERIPHERAL INTRAVENOUS CANNULA PLACEMENT  Patients in Group PIVC will receive peripheral intravenous cannula by the primary care provider in the ward. The device used will be 18 G conventional IV cannula with length of 45 mm and flow rate of 80 ml/ min. Aseptic precautions will be taken during cannula placement. Veins on the dorsum of hand and forearm will only be used for vascular access. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age with need for vascular access for more than one week for perioperative indications 
 
ExclusionCriteria 
Details  Patients with difficult venous access , emergency surgeries , immediate requirement of central venous catheter , CKD patients , pregnant patients  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To measure and compare the incidence of primary device failure for 1000 catheter days  catheter patency will be assessed every twenty four hours until device removal 
 
Secondary Outcome  
Outcome  TimePoints 
To measure and compare the incidence of complications for 1000 catheter days- phlebitis/ infiltration/ leak/ and thrombosis.  Catheter will be assessed every twenty four hours for complications until device removal 
To measure and compare the median catheter dwell time (Days)  Day of device removal 
To identify the number of devices utilised per patient (Ratio)  At the time of patient discharge 
To calculate the cost incurred by the patient for the VAD.  At the time of patient discharge 
To measure the patient satisfaction regarding overall performance and comfort of the VAD.  At the time of patient discharge 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   07/10/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  data will be available by contacting the principal investigator siddharth_chandan@yahoo.co.in

  6. For how long will this data be available start date provided 02-01-2026 and end date provided 27-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Venous access devices are an indispensable part of hospital care for surgical patients. Common indications for venous access devices are intravenous fluids, antibiotics, analgesics and supportive therapy. The duration of requirement of venous access device depends commonly on severity of patient’s illness, care plan, place of care and availability of alternate venous access sites. The surgical cohort has unique venous access requirements namely rapid fluid replacement during anesthesia, blood transfusions, short term peripheral administration of vasopressors in the operating room, antibiotic therapy for more than 7 days and prolonged intravenous fluid administration in patients undergoing laparotomies.

Peripheral intravenous cannula is the most frequently employed devices during patient admission but are associated with a failure rate of 40- 60 %.The common indications for PIVC removal are thrombophlebitis and catheter occlusion. Patients suffer from repeated pricks, interruption of therapy and dissatisfaction during hospital stay due to multiple PIVC insertions. The recommended dwell time for PIVC is 72 - 96 hours and thus are not right devices in patients requiring venous access more than 5 days. Long peripheral catheters are similar in design to peripheral intravenous cannula but are longer in length 8 - 10 cm and are inserted in veins above cubital fossa. They end distal to the axilla and have a median dwell time of 14 days. Ultrasound guided insertion success rates are 86 - 100 % for these catheters and have a failure rate of 14 % when compared with 42 % for PIVC.  LPCs have been studied in post cardiac surgery units and have been found to have longer dwell time and lower failure rate than PIVCs but such data regarding general perioperative cohort is lacking. Hence, we designed this trial to compare the efficacy of PIVC and LPC in surgical patients requiring venous access for 7 - 15 days in terms of device failure, average dwell time, costs of VAD, and complications such as phlebitis, occlusion and dislodgement. 
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