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Efficacy Safety Score in Postoperative Management

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ClinicalTrials.gov Identifier: NCT03438578
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Postoperative Nausea and Vomiting Device: Efficacy Safety Score monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: Efficacy Safety Score monitoring
According to data gathered from ESS and monitoring, the patients will receive needed care.
Other Name: Isansys, Patient Gateway System

No Intervention: Regular
Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward



Primary Outcome Measures :
  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 Outcome Measures :
  1. Pain measurement, Verbal Numeric Rating Scale [ Time Frame: 24 hours ]
    Reported pain hourly on a 11-digit scale

  2. Side-effects from postoperative treatment [ Time Frame: 24 hours ]
    Reported side-effects from postoperative medication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438578


Contacts
Contact: Erlend Johan Skraastad, MD +4792695992 ejskraastad@hotmail.com
Contact: Johan Raeder, Prof +4792249669 Johan.Rader@medisin.uio.no

Locations
Norway
St Olav University Hospital Recruiting
Orkdal, Norway
Contact: Erlend Johan Skraastad , MD    +4792695992    ejskraastad@hotmail.com   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
Study Director: Johan Raeder, Prof University of Oslo
Study Director: Erik Solligård, MD PhD St. Olavs Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03438578     History of Changes
Other Study ID Numbers: 2017/1903
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Patient safety
Postoperative care
Monitoring, physiologic
Safety management

Additional relevant MeSH terms:
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Nausea