Efficacy Safety Score in Postoperative Management
Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
September 24, 2020
CompletedSeptember 24, 2020
September 1, 2020
8 months
February 13, 2018
August 14, 2020
September 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Pain Measurement, Verbal Numeric Rating Scale
24 hours
Patient Satisfaction
24 hours
Study Arms (2)
Efficacy Safety Score monitoring
EXPERIMENTALPatients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward
Regular
NO INTERVENTIONPatients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward
Interventions
According to data gathered from ESS and monitoring, the patients will receive needed care.
Eligibility Criteria
You may qualify if:
- undergoing surgery
- expectedly to be treated and observed in hospital for more than 24 hours postoperatively
You may not qualify if:
- refusal of participation
- poor communication capabilities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
Study Sites (1)
St Olav University Hospital
Orkdal, Norway
Related Publications (1)
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.
PMID: 31608431RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erlend Johan Skraastad
- Organization
- St Olavs Hospital
Study Officials
- STUDY DIRECTOR
Johan Raeder, Prof
University of Oslo
- STUDY DIRECTOR
Erik Solligård, MD PhD
St. Olavs Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2018
First Posted
February 19, 2018
Study Start
March 5, 2018
Primary Completion
October 18, 2018
Study Completion
March 1, 2019
Last Updated
September 24, 2020
Results First Posted
September 24, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share