| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
ï¶ ASA I/II/III
ï¶ 18 to 60 Years of age
ï¶ Surgeries requiring arterial cannulation
|
|
| ExclusionCriteria |
| Details |
ï¶ Patient refusal
ï¶ Peripheral vascular disease
ï¶ BMI>30kg/cm2
ï¶ Patients with coagulopathy
ï¶ Local infection at site of cannulation
ï¶ Pregnancy
|
|
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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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