Efficacy Safety Score in Postoperative Management

Not Applicable

Completed

• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting
• Interventions: Device: Efficacy Safety Score monitoring

• Registration Number: NCT03438578
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-19
• Study Start: 2018-03-05
• Primary Completion: 2018-10-18
• Study Completion: 2019-03-01
• Results First Submitted: 2020-08-14
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efficacy Safety Score monitoring	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

St Olav University Hospital; 🇳🇴 Orkdal, Norway