Back to resultsEfficacy Safety Score in Postoperative Management
Primary Purpose
Pain, Postoperative, Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Efficacy Safety Score monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring Patient safety, Postoperative care, Monitoring, physiologic, Safety management
Eligibility Criteria
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
Sites / Locations
- St Olav University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Efficacy Safety Score monitoring
Regular
Arm Description
Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward
Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Outcomes
Primary Outcome Measures
Time to Mobilization
The measured postoperative time when patient can stand and able to walk one or more steps, with or without support
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03438578
First Posted
February 13, 2018
Last Updated
September 2, 2020
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT03438578
Brief Title
Efficacy Safety Score in Postoperative Management
Official Title
Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting
Keywords
Patient safety, Postoperative care, Monitoring, physiologic, Safety management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Efficacy Safety Score monitoring
Arm Type
Experimental
Arm Description
Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward
Arm Title
Regular
Arm Type
No Intervention
Arm Description
Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Intervention Type
Device
Intervention Name(s)
Efficacy Safety Score monitoring
Other Intervention Name(s)
Isansys, Patient Gateway System
Intervention Description
According to data gathered from ESS and monitoring, the patients will receive needed care.
Primary Outcome Measure Information:
Title
Time to Mobilization
Description
The measured postoperative time when patient can stand and able to walk one or more steps, with or without support
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Measurement, Verbal Numeric Rating Scale
Description
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
Title
Patient Satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Raeder, Prof
Organizational Affiliation
University of Oslo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erik Solligård, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olav University Hospital
City
Orkdal
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31608431
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy Safety Score in Postoperative Management
We'll reach out to this number within 24 hrs