NCT04617106

Brief Summary

Radial Artery cannulation using conventional palpation vs USG guided Dynamic needle tip positioning (DNTP) method.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

December 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

October 22, 2020

Last Update Submit

September 18, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • First pass success rate between conventional palpation method with USG-guided DNTP method

    compare the successfully obtaining an arterial waveform with a single skin puncture, irrespective of the number of needle re-directions needed.

    through study completion, an average of 6 months

Secondary Outcomes (4)

  • To compare the number of skin punctures between conventional palpation method with USG-guided DNTP method

    through study completion, an average of 6 months

  • To compare the number of cannulae used for successful radial artery cannulation between conventional palpation method with USG-guided DNTP method

    through study completion, an average of 6 months

  • To compare the time duration for successful cannulation in conventional palpation method with USG-guided DNTP method

    through study completion, an average of 6 months

  • To compare overall five-minute success rate in conventional palpation method with USG-guided DNTP method.

    through study completion, an average of 6 months

Study Arms (2)

Conventional Palpation group

ACTIVE COMPARATOR

In patients undergoing elective surgery who need arterial catheter placement, radial artery cannulation will be done using the conventional palpation method.

Procedure: Radial artery cannulation

DNTP group

ACTIVE COMPARATOR

In patients undergoing elective surgery who need arterial catheter placement, radial artery cannulation will be done using USG-guided dynamic needle tip positioning method.

Procedure: Radial artery cannulation

Interventions

cannulation of Radial artery using standard IV cannula (axillary drug port will be taped using opaque adhesive)

Conventional Palpation groupDNTP group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective surgeries Patients who require arterial cannulation as determined by the consultant anaesthesiologist Age: 18 years or above

You may not qualify if:

  • Type D ulnopalmar arch patency during Barbeau test Patient with a documented history of peripheral vascular disease Infection or other soft tissue lesions at the site of cannulation A surgical procedure involving the cannulation site Patients receiving inotropes or vasopressors.
  • History of radial artery cannulation within the past one month at the planned cannulation site.
  • Patients with an arterial catheter in-situ (any site)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuwan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In patients undergoing elective surgery who need arterial catheter placement, radial artery cannulation will be done using either the conventional palpation method or USG-guided dynamic needle tip positioning method before the induction of anaesthesia. In one group, radial artery cannulation will be done using the conventional palpation method, and in the second group, USG-guided dynamic needle tip positioning method will be employed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, PGY II, Anesthesia and Critical care

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 5, 2020

Study Start

December 3, 2020

Primary Completion

March 27, 2021

Study Completion

March 27, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
data will be available within 2 months of completion of study, around August 2021. It will be available for 2yrs form the time of completion of study.
Access Criteria
anyone interested in similar research can access.

Locations