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OpenTrials
Completed

NCT Number: NCT01742416

Ultrasound Assisted Arterial Cannulation in Small Children

Arterial cannulation is a commonly performed invasive procedure in the operation room, the emergency department, and in the intensive care unit. The indications include the need for continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated blood sampling for laboratory evaluation. This procedure can be challenging even in the best of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse may, however be weak or absent in patients with hypotension, edema, obesity or local thrombosis due to previous arterial cannulation in the same location. Furthermore, the catheter may not be passed successfully into the artery, despite apparent good blood return on initial puncture, or hematoma and spasms of the artery may develop after failed attempts, thus making further attempts even more difficult. While ultrasound (US) is being used with increasing frequency for central venous access, fewer clinicians are familiar with US-guided arterial catheterization. The aim of this study is to investigate if ultrasound facilitates arterial cannulation in children ≤24 months compared with the palpation method and to investigate the potential extra costs/savings of introducing the method. This study hypothesizes that the ultrasound method will facilitate arterial cannulation in small children compared with the palpation method.

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Key information

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 24 months or younger
  • Children undergoing elective surgical procedures where arterial cannulation is planned by the attending anaesthetist. These procedures include cardiac surgery, craniotomies, cranial vault surgery, and some abdominal procedures.

Exclusion criteria

  • Refusal of consent from the parents
  • Refusal of participation from the anaesthetist
  • Children with anticipated circulatory instability after anaesthesia induction
  • Pulmonary hypertension defined as an estimated pulmonary arterial pressure which is greater than or equal to 66% of systemic blood pressure
  • Children with severe heart failure (right and/or left)

Treatment and study plan

Ultrasound

Procedure

Arterial cannulation facilitated by ultrasound.

Palpation Method

Procedure

Arterial cannulation by palpation method.

Primary outcomes

  1. Number of Attempts

    Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)

    To measure the number of attempts to cannulate the artery per participant.

Secondary outcomes

  1. Time to Successful Cannulation

    Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)

    To measure the difference between the time when the palpating finger touches the skin (palpation group) or the gel is applied to the skin (US group) at the first intended cannulation site and the time when the arterial cannula is correctly in place.

  2. Rate of Success of First Attempt

    Time frame: Change from baseline to success of first attempt, when artery is successfully cannulated on first attempt (estimated average of 30 minutes)

    The rate of success of first attempt to cannulate the artery of each participant.

  3. Number of Attempted Sites

    Time frame: Change from baseline to successful cannulation (estimated average of 30 minutes)

    To measure the total number of attempted sites.

  4. Learning Curve

    Time frame: At approximately 4 months

    To measure the learning curve for each of the participating anaesthetist.

  5. Cost of Procedure

    Time frame: Duration of the study (6 months)

    To measure the estimated cost of the procedure.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Ultrasound Assisted Arterial Cannulation in Small Children - To See or Not to See?

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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