P07
Conditions
Interventions
Group 1: Observational study. Video recording of very preterm infants during intravascular catheter placement and synchronized documentation of vital signs and ventilator settings.
Sponsors
LMU Klinikum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronological age =7 days after birth - Clinical decision for an intravenous or intraarterial catheter - Infants cared for at the LMU hospital at the time of intervention
Exclusion criteria
Exclusion criteria: - Arterial or venous malformations - Inability of the parents to understand the study procedures due to cognitive or linguistic reasons - Declined parental consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the oxygen saturation index, i.e. (MAP * FiO2 * 100) / SpO2 at pre-specified timepoints over the duration of the procedure Data will be collected by analyzing the video recording of vital parameters and ventilation parameters at the following timepoints Timepoints of data collection for PVC (peripheral venous catheter): - Baseline: prior to first handling of the infant - 20 seconds after first handling of the infant - 10 seconds before the end of the first handling of the infant - First disinfection of insertion site - Needle insertion - 10 seconds after needle insertion - If successful: Beginning and end of catheter fixation - If successful: 5 minutes after the end of the procedure including subsequent nursing care Timepoints of data collection for PICC-line (peripherally-inserted central catheter), UAC (umbilical arterial catheter) and UVC (umbilical venous catheter) : - Baseline: prior to first handling of the infant - 20 seconds after first handling of the infant - First disinfection of insertion site - Application of sterile drapes - Needle prick (only for PICC line) - Beginning of insertion of catheter (PICC-line/UAC/UVC) - End of insertion (PICC-line/UAC/UVC) - If successful: Beginning and end of catheter fixation | — |
Secondary
| Measure | Time frame |
|---|---|
| - Physiological outcomes at prespecified timepoints: vital signs, i.e. SpO2, HR, RR, pressure levels, tidal volumes, FiO2 - Maximum and minimum values of the respective vital signs, i.e. SpO2, HR, RR, pressure levels, tidal volumes, FiO2 during the entire procedure - Duration of catheter insertion - Effect of potential covariates (e.g. type of access, experience of the operator, site of insertion, use of visualization device, number of attempts) | — |
Countries
Germany
Contacts
Public ContactVincent Gaertner
LMU Klinikum
Outcome results
None listed