Efficacy Safety Score in Postoperative Management

NCT ID: NCT03438578

Last Updated: 2020-09-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-03-01

Brief Summary

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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

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Conditions

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Pain, Postoperative Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Efficacy Safety Score monitoring

Intervention Type DEVICE

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

Regular

Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Efficacy Safety Score monitoring

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

Intervention Type DEVICE

Other Intervention Names

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Isansys, Patient Gateway System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Raeder, Prof

Role: STUDY_DIRECTOR

University of Oslo

Erik SolligÄrd, MD PhD

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

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St Olav University Hospital

Orkdal, , Norway

Site Status

Countries

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Norway

References

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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. doi: 10.1111/aas.13492. Epub 2019 Nov 12.

Reference Type RESULT
PMID: 31608431 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017/1903

Identifier Type: -

Identifier Source: org_study_id

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