Critically ill newborns admitted to the Neonatal Intensive Care Unit
Conditions
Interventions
The research participants will be the newborns and infants admitted to the NICU of the research site within the time stipulated by the researchers. Thus, to obtain statistical significance, regarding
2. If the NB/infant is included, the nurse will apply the informed consent form to the legal guardian
3. After signing the informed consent form, the RN/infant will undergo random allocation to one of the groups: intervention or control
4. After randomization, the nurse will submit the RN/infant to the randomized insertion technique. At the time of insertion, to answer the outcome variable "successful insertion", the following will b
Sponsors
Universidade Federal do Paraná
Hospital Infantil Waldemar Monastier
Eligibility
Inclusion criteria
Inclusion criteria: Newborns and infants admitted to the Neonatal Intensive Care Unit; PICC indication based on the Michigan Appropriateness Guide to Intravenous Catheters (MAGIC); signature of the Informed Consent Form by the legal guardians
Exclusion criteria
Exclusion criteria: Newborns and infants with medical diagnosis of vascular malformation; newborns and infants who need a double lumen central venous catheter; thrombocytopenia = 50,000 mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first box will contain the first primary outcome. This will be identified as "Primary outcome 1", which will be: Evaluate successful insertion through progression of the catheter to the cavo-atrial junction, verified on chest x-ray (if the device is inserted in the upper limbs, head or jugulars) or abdominal x-ray (if the device is inserted in the lower limbs). ;The second box will contain the second primary outcome. This will be identified as "Primary Outcome 2", which will be: Assessing the absence of complications through the appearance of complications during catheter insertion and/or maintenance. During insertion, adverse events will be considered hematoma, inadvertent arterial puncture, bleeding of difficult hemostasis. During maintenance, phlebitis, local and systemic infection, obstruction, extravasation, infiltration, thrombosis, and migration will be considered complications. These complications will be evaluated daily through the following actions: (1) Phlebitis: measured through the Maddox Scale (standardized at the institution); (2) Local infection: measured through daily inspection of the insertion site, characterized by the signs/symptoms: heat, flushing, edema, pain, functional limitation of the limb and presence of exudate; (3) Bloodstream infection: Measured by clinical signs of infection (dysthymia, bradycardia, apnea, food intolerance, worsening respiratory distress, glucose intolerance, hemodynamic instability, and hypoactivity) and/or positive peripheral and/or central blood cultures; (4) Obstruction: Measured by the inability to flush the catheter (5) Extravasation: measured by flogging signs around the puncture, mainly edema of higher visibility; (6) Infiltration: measured if flogging signs at the puncture site and adjacent structures, mainly observed by skin tone change (increased hyperemia and even tissue necrosis); - Thrombosis: measured by the visible enlargement of the limb/site where the PICC was inserted, compared to the same contr | — |
Secondary
| Measure | Time frame |
|---|---|
| The third box will contain the first secondary outcome. This will be identified as "Secondary outcome 1", which will be: pain during catheterization, measured by applying the Neonatal Infant Pain Scale (NIPS), being positive for pain from a score greater than or equal to 3.;The fourth box will contain the second secondary outcome. This will be identified as "Secondary Outcome 2", which will be: procedure time, measured in minutes/hours by an external observer, counted from the venipuncture until the complete progression of the catheter inside the blood vessel.;The fifth box will contain the third and last secondary outcome. This will be identified as "Secondary outcome 3", which will be: number of puncture attempts, also measured by an external observer. | — |
Countries
Brazil
Contacts
Public ContactHigor Pereira
Outcome results
None listed