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OpenTrials
Completed

NCT Number: NCT03438578

Efficacy Safety Score in Postoperative Management

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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Key information

Conditions

Pain, Postoperative Nausea Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Olav University Hospital

Orkdal, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efficacy Safety Score monitoring

Device

According to data gathered from ESS and monitoring, the patients will receive needed care.

Other names: Isansys, Patient Gateway System

Primary outcomes

  1. Time to Mobilization

    Time frame: 24 hours

    The measured postoperative time when patient can stand and able to walk one or more steps, with or without support

Secondary outcomes

  1. Pain Measurement, Verbal Numeric Rating Scale

    Time frame: 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.

  2. Patient Satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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