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CTRI Number  CTRI/2024/02/063121 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of a new technique performed with the help of ultrasound versus older conventional technique for putting a cannula in the artery of the foot. 
Scientific Title of Study   Comparison Of Ultrasound guided Short Axis- Dynamic Needle Tip Positioning Versus Palpatory technique for dorsalis pedis artery cannulation in adults-A Randomized controlled 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  Sravani P 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Anesthesiology, Pain Medicine and Critical Care, Room 5011, 5th Floor, Teaching Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  08919506740  
Fax    
Email  sravanineta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dalim Kumar Baidya 
Designation  Professor 
Affiliation  AIIMS New Delhi 
Address  Department of Anesthesiology, pain Medicine and Critical Care, Room 5011, 5th Floor, Teaching Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9871568534  
Fax    
Email  dalimkumar.ab8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sravani P 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Department of Anesthesiology, Pain Medicine and Critical Care, Room 5011, 5th Floor, Teaching Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  08919506740  
Fax    
Email  sravanineta@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Room 5011, 5th Floor, Teaching Block, AIIMS New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Sravani P  AIIMS New Delhi  Department of Anesthesiology, Pain Medicine and Critical Care, Main OT Complex, OT 1-12, 8th Floor, Ward Block, AIIMS New Delhi
South
DELHI 
8919506740

sravanineta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, New Delhi  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 
Comparator Agent  Conventional palpatory technique  After aseptic precautions, dorsalis pedis artery will be cannulated by classic conventional palpatory method. Navicular bone will be used as landmark. 
Intervention  Ultrasound guided dynamic needle tip positioning (DNTP) technique   In DNTP group, a Sonosite M Turbo ultrasound machine with a linear USG probe of 8-13 MHz with small footprint will be used (Sonosite Inc, Bothell, WA, USA). After identifying the artery in a short axis out of plane approach a 20G BD arterial cannula will be inserted keeping the artery in the centre of the screen. The needle will be advanced in the midline till a hyperechoic dot will be visible in the centre of the screen. Now the probe will be moved proximally without moving the needle till the hyperechoic dot disappears. The needle will then be advanced towards the DPA with the probe held in place. Once the needle punctures the DPA and is visible as hyperechoic dot, the probe will be moved proximally again till the dot disappears. The needle again will be advanced till the needle tip is visible in the centre of the artery as hyperechoic dot. The same will be repeated and after confirmation that the needle tip remains in the DPA, the outer catheter will be pushed to the end, and the stylet will be removed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   ASA I/II/III
 18 to 60 Years of age
 Surgeries requiring arterial cannulation
 
 
ExclusionCriteria 
Details   Patient refusal
 Peripheral vascular disease
 BMI>30kg/cm2
 Patients with coagulopathy
 Local infection at site of cannulation
 Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate of dorsalis pedis artery cannulation  Approximately 15 minutes after the induction of anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1. Overall success rate
2. Total number of attempts
3. Time required for successful cannulation
4. Incidence of posterior wall puncture
5. Incidence of hematoma formation
 
Approximately 15 minutes after the induction of anesthesia 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   04/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

Arterial cannulation is one of the frequently performed procedures in patients with anticipated massive blood loss, significant hemodynamic changes or requirement of frequent blood gas sampling in perioperative period. Various arteries can be used for cannulation like radial, ulnar, femoral, dorsalis pedis and posterior tibial artery. Radial artery is most commonly chosen for arterial cannulation. However, Dorsalis pedis artery (DPA) is selected as an alternative to radial artery cannulation when there is no access or unsuccessful cannulation of radial artery. DPA has good collateral flow, presents minimal patient inconvenience and has low incidence of complication.

When compared to radial artery cannulation, DPA has a 12.7% lower success rate (1). Traditionally DPA is cannulated by palpatory method using navicular bone as landmark.

Ultrasound (US) is used as an aid for arterial cannulation to improve the success rate and lessen complications. Numerous approaches have been used for US guided arterial cannulation. Among them, Short Axis Out-Of-Plane (SA-OOP) and long-axis in-plane (LAIP) approaches are commonly used. In SA-OOP approach, an US image of part of the shaft or the tip of the cannula in cross- section, will appear as a hyperechoic dot; whereas in LAIP approach, the entire  path of needle can be visualized as a hyperechoic line.  The first attempt and overall success rate of DPA cannulation has been found to be similar in the palpatory and ultrasound guided LAIP approach (2). With both palpatory and LAIP approach, first attempt success rate of DPA cannulation have been poor (60% and 76% respectively) (2).

In short axis view the US image from the shaft as well as tip of the cannula will appear as hyperechoic dot. In order to overcome this problem dynamic needle tip (DNTP) approach was introduced. DNTP technique, a modification of SA-OOP approach, has shown to have higher first attempt and overall success rate and shorter cannulation time compared to palpatory method for DPA in infants and small children (3).

To the best of our knowledge, there are no studies that compared the SA-DNTP vs palpatory method for dorsalis pedis artery in adults. Therefore, we planned to conduct a study to compare the US guided SA-DNTP versus palpatory technique in dorsalis pedis artery. We hypothesise SA-DNTP technique has higher first attempt success rate for dorsalis pedis artery cannulation as compared to palpatory technique.


Primary objective:

First attempt success rate of dorsalis pedis artery cannulation.

 

Secondary objectives:

1. Overall success rate

2. Total number of attempts

3. Time required for successful cannulation

4. Incidence of posterior wall puncture

 5. Incidence of hematoma formation


Study Design: A Prospective randomized controlled trial.

Study Setting:

This study will be conducted in the Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi after obtaining approval of institutional ethics committee and CTRI registration.

Study Duration:

The total study duration will be approximately 2 years.

Inclusion criteria

 The study population will include adult patients fullfilling the following criteria - 

ASA I/II/III

18 to 60 Years of age

Surgeries requiring arterial cannulation

 Exclusion Criteria

Patient refusal

Peripheral vascular disease

BMI>30kg/cm2

Patients with coagulopathy

Local infection at site of cannulation

Pregnancy



Sample size calculation:

Anand et al reported first attempt success rate of DPA cannulation as 60% by palpatory method and 76% by USG guided LAIP approach. In infants and small children Takeshita et al reported first attempt success rate as 85% for DPA

cannulation with DNTP approach. We considered first attempt success rate of DNTP approach in adults  would be at least similar or higher to that in infants. Therefore, assuming 85% success rate with DNTP method and 60% with palpatory method with a power of 80% and a significance level of 0.05, n=98 patients will be required. Considering 10% dropout rate, we will enrol n=108

patients.


Randomization:

 Patients will be randomized using Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique. Random number tables will be generated with the

help of computer software (ww.randomizer.org). The sealed envelopes will be sequentially labelled  from 1 to 108. Each envelope will contain a folded slip which may have GROUP D (DNTP) or GROUP P (PALPATORY)

 

Blinding:

 Due to nature of study blinding will not be possible. However, the patients and the data outcome assessor will be blinded to the group allocation.


Definitions

Successful arterial cannulation will be confirmed by presence of arterial waveform on the monitor.

Attempt - one new skin penetration by cannula is one attempt

First attempt success rate – number (%) of patients successfully cannulated in first attempt

Overall success rate - number (%) of patients successfully cannulated within three attempts.

Time for cannulation - defined as time interval between skin penetration by cannula and confirmation of arterial waveform on monitor. 

Hematoma will be defined by localised swelling on the puncture site.

Posterior wall puncture will be identified by appearance of localized hematoma beneath the artery in ultrasound scan.


 
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