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Efficacy Safety Score in Postoperative Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438578
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : October 18, 2019
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

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Study Type : Interventional  (Clinical Trial)
Actual 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 : March 5, 2018
Actual Primary Completion Date : October 18, 2018
Actual Study Completion Date : March 1, 2019

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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Norway
St Olav University Hospital
Orkdal, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Johan Raeder, Prof University of Oslo
Study Director: Erik Solligård, MD PhD St. Olavs Hospital
Publications of Results:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03438578    
Other Study ID Numbers: 2017/1903
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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