A Study of a Comprehensive, Holistic Approach to Sedation, Pain, Delirium, Early Mobilization, and Family Engagement in the Pediatric Intensive Care Unit
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004000
Sponsor Protocol Number: 16-004000
About this study
The purpose of this study is to evaluate the subjective impressions on workload demands compared to perceived benefits of a new quality improvement plan of patient care in the Pediatric Intensive Care Unit. The frequency and length of education and training sessions will also be recorded, and PICU patient charts (electronic health records) will be reviewed to document the number and frequency of consults and adherence to the patient care plan.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Chronologic age > 2 months regardless of gestational age at birth
- Expected PICU stay > 3 calendar days as predicted by the consultant intensivist
- Need for invasive or non-invasive mechanical ventilation regardless of patient interface
- Oxygen delivered via nasal cannula regardless of heat, humidification, or flow rate will not be considered (i.e. heated, humidified, high flow nasal cannula)
Exclusion Criteria
- Prior enrollment for data collection in this study
- Baseline pediatric cerebral performance or overall performance categories (PCPC or POPC) of 4 (severe disability), 5 (coma or vegetative state), or 6 (brain death).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Grace Arteaga, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available