Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Pain: Wrong-Baker FACES pain rating scale |
The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain. |
Change from before therapy session to immediately after therapy session is completed. |
|
Primary |
Anxiety: Children's Anxiety Meter-State (CAM-S) |
The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. Children are instructed to "Pretend that all of your worried or nervous feelings are in the very bottom down here. If you are a little bit worried or nervous, the feelings might come up just a little bit. If you are very, very worried or nervous, the feelings might go all the way to the top. Put a line showing how much worry or nervousness you feel." |
Change from before therapy session to immediately after therapy session is completed. |
|
Primary |
Intervention Acceptability |
Patient Satisfaction Measure: Investigator-developed Satisfaction Measure contains one item which asks the participants to rank their satisfaction with the intervention from 1-5 (not at all - very much) |
Within 1 week of study completion |
|
Primary |
Hospital Acquired Infections |
Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Rates of Enteroviruses will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Rates Influenza will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Surgical-Site Infections (SSI) will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Hospital Acquired Infections |
Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record. |
Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion. |
|
Primary |
Sedation Exposure |
Sedative and analgesic medications will be will be abstracted from the electronic medical record (EMR) in order to calculate sedation frequency for 4 hours after each PT/OT session in which PARO was used |
4 hours after each individual session |
|
Primary |
Sedation Exposure |
Sedative and analgesic medications will be will be abstracted from the electronic medical record (EMR) in order to calculate sedation intensity for 4 hours after each PT/OT session in which PARO was used |
4 hours after each individual session |
|
Primary |
Microbial Contamination Screening |
The ATP Monitoring with SystemSURE Plus Process uses a process which monitors levels of ATP Bioluminescence We will implement an established cleaning protocols and then measure ATP before the PT/OT session by swabbing PARO on the following areas: head, right flipper, left flipper, bottom [by on/off switch], top left back area, top right back area, stomach [underneath]. |
Completed immediately after each individual session |
|
Primary |
Activity performance form |
The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes), the time to the patient's first out of bed movement, as well as the number and types of range of motion exercises performed (Passive, Active assist, and Active) |
Immediately after each intervention therapy sesison |
|
Primary |
Physiologic variables |
Heart Rate |
]Change from before therapy session to immediately after therapy session is completed. |
|
Primary |
Physiologic variables |
Blood Pressure |
]Change from before therapy session to immediately after therapy session is completed. |
|
Primary |
Physiologic variables |
Respiratory Rate |
]Change from before therapy session to immediately after therapy session is completed. |
|
Primary |
Physiologic variables |
Oxygen Saturation |
]Change from before therapy session to immediately after therapy session is completed. |
|