Clinical trial NCT03647293: Less Pain in Neonates During Central Lines Insertion
Official title: Ultrasound Guided Central Line Insertion in Neonates: Pain Score Results From a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheter
Neonates
Pain
Keywords: Central Catheter
Central Line
Internal Jugular Vein
Neonate
Peripherally Inserted Central Line
Ultrasound Guided
Pain Score
Lead sponsor: Saint George Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 61
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain score difference
timeFrame: Through study completion, around 7 months
Secondary outcomes:
measure: The number of first successful attempts
timeFrame: Through study completion, around 7 months
measure: Number of total attempts
timeFrame: Through study completion, around 7 months
measure: Procedure duration
timeFrame: Through study completion, around 7 months
Other outcomes:
Locations:
Study officials:
affiliation: Saint Georges Hospital University Medical Center
name: Dany Al Hamod, MD
role: PRINCIPAL_INVESTIGATOR
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