Children and Adolescents on the PICU suffering from distress, agitation and delir
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients admitted to the PICU written informed consent by guardians or patients’ consent/assent where applicable
Exclusion criteria
Exclusion criteria: missing written informed consent/assent end-stage palliative care Children with visual or hearing impairments, or with severe developmental delays that would severely limit the participation in this study according to parental report.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Comfort-B scales during the study period; measured at the beginning of the study and after 1,2,4 and 6 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the SOS-PD scale, dosage/use of sedatives and antipsychotics, changes in vital signs (heart rate and respiratory rate in min, blood pressure in mmHg, SpO2 saturation in %), changes in ventilator settings (PIP and PEEP in cmH2O, FiO2, respiratory rate per minute), salivary cortisol levels in µg/l | — |
Countries
Germany
Contacts
Evangelisches Klinikum Bethel, Universitätskinderklinik OWL der Universität Bielefeld, Campus Bielefeld-Bethel