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Less Pain in Neonates During Central Lines Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03647293
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dany Al-Hamod, Saint George Hospital

Brief Summary:

Central venous access is an imperative measure used in neonates whether being a peri-operative measure for children undergoing cardiac procedures for congenital heart diseases or as a mean of nutrition in neonatal enteral malnutrition and drug administration in oncology patients. Central catheters fall into two categories, a peripherally inserted central catheter (PICC) line or centrally inserted central catheters (CICC). Although these two modalities practically have the same aim, identifying the more effective technique is imperative for deciding which procedure should be applied to ameliorate patient outcomes. Many studies have been previously done that delineate the indications for central venous access with practically no absolute contraindications. These indications include central venous pressure (CVP) monitoring, poor venous access, volume resuscitation, and prolonged venous access in critically ill patients, total parenteral nutrition (TPN), cardio-pulmonary resuscitation and medication administration. Centrally inserted catheters have evolved from being blindly inserted catheters using landmarks techniques, is the usual standard of care, to being placed under direct visualization using ultrasound guidance. Since its first use back in the 90's, ultrasound guided insertion of central venous catheters has gained attention and successful attempts have been made to improve this technique. US-guidance initially used acoustic Doppler techniques but is now largely replaced by two-dimensional (2D) imaging and internal jugular vein (IJV) being the preferred site of insertion by US over femoral and subclavian vein. Several studies have compared these two techniques. Small-caliber vessels remain a great challenge in the pediatric population which backup the use of imaging modalities for a successful and safer insertion of CVCs.

This study aims to develop a better understanding of pain during central line insertions, compare pain scores between the two techniques in order to adopt the less painful technique and ultimately provide insight about the use of analgesics during these procedures for a better outcome.


Condition or disease Intervention/treatment Phase
Central Venous Catheter Neonates Pain Procedure: Ultrasound Guided Central Catheter Insertion Procedure: Peripherally Inserted Central Catheter Not Applicable

Detailed Description:

A single-center prospective randomized controlled study of neonates (preterm and term babies) who underwent an elective or emergent central line insertion between November 2016 and May 2017 was conducted at SGHUMC Neonatal Intensive Care Unit. Hospital's Institutional Review Board approved the study and an informed parental consent was signed for study entry. Inclusion criteria included neonates requiring TPN, antibiotic therapy for at least 7 days, and babies with poor or difficult venous access. Exclusion criteria included refusal to sign consent, patients with previously attempted or placed central lines, and patients who were converted from one technique to the other. Patients were randomized into the control and intervention group through a flip of coin each time a patient enrolled in the study The catheter used for all the patients was an epicutaneo-cava-catheter (ECC), silicone tube material kit, 24G, VYGON® (Aachen, Germany). All procedures were performed under sterile precautions such as hand washing, use of sterile gloves and gowns, facemask, hair cover, and protective eyewear.

The control group consisted of neonates who underwent a PICC line placement. The method of insertion performed followed the procedure previously described by Pettit. Patients in the intervention group underwent US-IJV. This procedure was carried out as follows: The patient's skin was sterilized with chlorhexidine gluconate and the area was infiltrated with local anesthetic agent (lidocaine). Vascular cannulation was performed using the ECC's winged needle. The target vessel was located via the US dynamic (real-time) method. At the point of needle insertion, the ECC was placed through the needle without guide wire placement. Once the catheter was inserted, a gentle aspiration was performed to show blood flow through the 3 ml syringe that was connected to the ECC. The catheter was then secured and fixed with simple steri-strips and covered by the transparent dressing. Both techniques were performed by two institutional neonatologists who according to their expertise, one performed all PICC line placements while the other performed all US-IJV.

Transducer selection and the axis of visualization are important to consider in the use of US for ECC, as such a linear 6-13 MHz transducer Sonosite M-turbo was used (manufacturer's recommendations). The transverse view shows the vessel under the transducer and the adjacent structures. The tip of the needle is visualized and inserted at a 45° angle. The longitudinal view helps to track the needle progression toward the IJV. Post procedural chest radiography was done for both groups to confirm placement and evaluate for complications.

The primary outcome measured was the pain score difference between Ultrasound inserted central line and peripherally inserted central line. The pain score was measures using the Neonatal Pain, Agitation and Sedation Scale (N -PASS). The N-PASS is based on several criteria: crying / irritability, behavior / state, facial expression, extremities / tone and vital signs. Patient characteristics such as gestational age, age, gender, admission diagnosis, weight have been taken into account and the scores was recorded by the nurse in charge of the baby before and during the procedure. Pain score difference was calculated by subtracting the score during the procedure from the pain score before the procedure.

The secondary outcome measures included the number of first successful attempts, number of total attempts and procedure duration. Additional patient information collected included gender, TPN administration, gestational age, birth weight and diagnosis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ultrasound Guided Central Line Insertion in Neonates: Pain Score Results From a Prospective Study
Actual Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Control Group
Neonates who underwent a peripherally inserted central catheter
Procedure: Peripherally Inserted Central Catheter
Active Comparator: Intervention Group
Neonates who underwent an Ultrasound Guided Central Catheter Insertion
Procedure: Ultrasound Guided Central Catheter Insertion



Primary Outcome Measures :
  1. Pain score difference [ Time Frame: Through study completion, around 7 months ]
    The patient pain score will be assessed prior to the procedure and during. The difference in pain score will be calculated as a representation of the increased pain inflicted by the procedure itself. This difference in pain scores will be compared across the 2 different interventions


Secondary Outcome Measures :
  1. The number of first successful attempts [ Time Frame: Through study completion, around 7 months ]
    With each procedure the number of attempts will be registered for each procedure, comparing between the 2 different interventions the number of successful attempts from first trial.

  2. Number of total attempts [ Time Frame: Through study completion, around 7 months ]
    With each procedure the number of attempts will be registered for each procedure, the total number of trials will be compared between the 2 different interventions

  3. Procedure duration [ Time Frame: Through study completion, around 7 months ]
    The procedure duration is the time from the start of the procedure till successful insertion of the central catheter. The total procedural duration will be compared between the 2 different interventions



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neonates requiring TPN
  • antibiotic therapy for at least 7 days
  • babies with poor or difficult venous access

Exclusion Criteria:

  • refusal to sign consent
  • patients with previously attempted or placed central lines
  • patients who were converted from one technique to the other

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647293


Sponsors and Collaborators
Saint George Hospital
Investigators
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Principal Investigator: Dany Al Hamod, MD Saint Georges Hospital University Medical Center

Publications:
Bhatt et al. Indications and complications of central venous catheterization in critically ill children in intensive care unit. National Journal of Medical Research 2012;2:1.85-88.
Costa P, Camargo P, Bueno M, Kimura A. Measuring pain in neonates during placement of central line catheter via peripheral insertion. Acta Paul Enferm 2010;23(1):35-40.

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Responsible Party: Dany Al-Hamod, Associate Professor in Pediatrics, Head of the Post-Graduate Medical Education Office, Saint George Hospital
ClinicalTrials.gov Identifier: NCT03647293     History of Changes
Other Study ID Numbers: IRB/O/036-16/1916
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dany Al-Hamod, Saint George Hospital:
Central Catheter
Central Line
Internal Jugular Vein
Neonate
Peripherally Inserted Central Line
Ultrasound Guided
Pain Score