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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efficacy Safety Score monitoring | Experimental | Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward |
|
| Regular | No Intervention | Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efficacy Safety Score monitoring | Device | According to data gathered from ESS and monitoring, the patients will receive needed care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Mobilization | The measured postoperative time when patient can stand and able to walk one or more steps, with or without support | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan Raeder, Prof | University of Oslo | Study Director |
| Erik Solligård, MD PhD | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olav University Hospital | Orkdal | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31608431 | Result | Skraastad EJ, Borchgrevink PC, Nilsen TIL, Raeder J. Postoperative quality and safety using Efficacy Safety Score (ESS) and a wireless patient monitoring system at the ward: A randomised controlled study. Acta Anaesthesiol Scand. 2020 Mar;64(3):301-308. doi: 10.1111/aas.13492. Epub 2019 Nov 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Regular | Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients > 18 years of age undergoing acute or elective surgery expected to be hospitalised > 24 hours postoperatively. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Mobilization | The measured postoperative time when patient can stand and able to walk one or more steps, with or without support | Posted | Mean | 95% Confidence Interval | hours | 24 hours |
|
24 hour after surgery
Low blood pressure Arrythmia Need for extra treatment Neurological events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erlend Johan Skraastad | St Olavs Hospital | 0047 79829184 | Erlend.Johan.Skraastad@stolav.no |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2018 | Sep 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
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. |
| 24 hours |
| Regular |
Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 24 hours |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 24 hours |
|
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 5 |
| 96 |
| EG001 | Regular | Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward | 0 | 99 | 2 | 99 | 0 | 99 |
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Pain treatment, nerve blocks | Nervous system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |