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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03438578
Other study ID # 2017/1903
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2018
Est. completion date March 1, 2019

Study information

Verified date September 2020
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date March 1, 2019
Est. primary completion date October 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Efficacy Safety Score monitoring
According to data gathered from ESS and monitoring, the patients will receive needed care.

Locations

Country Name City State
Norway St Olav University Hospital Orkdal

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & 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. d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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. 24 hours
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