Pain, Postoperative, Postoperative Nausea and Vomiting
Conditions
Keywords
Patient safety, Postoperative care, Monitoring, physiologic, Safety management
Brief summary
The primary aim of this project is to determine whether postoperative patients may benefit from the Efficacy Safety Score (ESS) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.
Interventions
DEVICEEfficacy Safety Score monitoring
According to data gathered from ESS and monitoring, the patients will receive needed care.
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing surgery * expectedly to be treated and observed in hospital for more than 24 hours postoperatively
Exclusion criteria
* refusal of participation * poor communication capabilities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Mobilization | 24 hours | The measured postoperative time when patient can stand and able to walk one or more steps, with or without support |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measurement, Verbal Numeric Rating Scale | 24 hours | Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome. |
| Patient Satisfaction | 24 hours | Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Efficacy Safety Score Monitoring Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward
Efficacy Safety Score monitoring: According to data gathered from ESS and monitoring, the patients will receive needed care. | 96 |
| Regular Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward | 99 |
| Total | 195 |
Baseline characteristics
| Characteristic | Regular | Total | Efficacy Safety Score Monitoring |
|---|---|---|---|
| Age, Continuous | 62 Years STANDARD_DEVIATION 13.3 | 62 Years STANDARD_DEVIATION 12.9 | 61 Years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Norway | 99 Participants | 195 Participants | 96 Participants |
| Sex: Female, Male Female | 37 Participants | 73 Participants | 36 Participants |
| Sex: Female, Male Male | 62 Participants | 122 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 99 |
| other Total, other adverse events | 5 / 96 | 0 / 99 |
| serious Total, serious adverse events | 0 / 96 | 2 / 99 |
Outcome results
Primary
Time to Mobilization
The measured postoperative time when patient can stand and able to walk one or more steps, with or without support
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Efficacy Safety Score Monitoring | Time to Mobilization | 10.1 hours |
| Regular | Time to Mobilization | 14.2 hours |
Secondary
Pain Measurement, Verbal Numeric Rating Scale
Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Efficacy Safety Score Monitoring | Pain Measurement, Verbal Numeric Rating Scale | 2.1 score on a scale |
| Regular | Pain Measurement, Verbal Numeric Rating Scale | 3.3 score on a scale |
Secondary
Patient Satisfaction
Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Efficacy Safety Score Monitoring | Patient Satisfaction | 4.9 score on a scale |
| Regular | Patient Satisfaction | 4.3 score on a scale |