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Evaluation of the Modified Early Warning Scoring System

Primary Purpose

Clinical Deterioration, Postoperative Complications, Nurse's Role

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MEWSS and Nursing Guide Application
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Clinical Deterioration focused on measuring Clinical deterioration, early warning score, nursing assessment, postoperative care, surgical nursing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having operated under general anesthesia
  • transferred to the post-anesthesia care unit (ASBU) and then to the service/ICU followed for 2 hours,
  • between 18-65 years old,
  • who have not had an operation with general anesthesia in the last six months,
  • no serious life-threatening complications developed during surgery,
  • patients willing to participate in the study

Exclusion Criteria:

  • data unavailable,
  • complications during surgery,
  • patients who did not undergo general anesthesia

Sites / Locations

  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

MEWSS and Nursing Guide Application will be used in the study group. MEWSS: The Modified Early Warning Score (MEWS) consists of a simple to use algorithm based on physiological parameters such as heart rate, respiratory rate, systolic blood pressure, temperature and level of consciousness. Nursing Guide Application (NGA): According to the follow-up carried out in this study: If the patient's MEWSS is 4 or below, a ten-minute follow-up was performed. If the MEWSS is five, then five-minute follow-up is passed, and if the score has not changed as a result of the follow-ups, five-minute follow-ups are continued. If the score decreased to four or less, ten-minute follow-up was started, if the score increased, five-minute follow-ups were continued, and the emergency team was informed and the patient was evaluated (the emergency team was informed about the study).

In the control group, the patients followed according to the Modified Early Warning Scoring System received routine care in the clinic.

Outcomes

Primary Outcome Measures

Effects of MEWSS and NGA use on complications and clinical status
Length of stay in ASBU (minutes), complications developed in ASBU, intervention time to complications (minutes), and where it was transferred after ASBU (clinical or intensive care unit)
Effect of MEWSS and NGA use on vital signs and MEWS
Heart rate (beats per minute), respiratory rate (respiratory rate / min.), systolic blood pressure (mmHg), temperature (centigrade degree -°C), level of consciousness (AVPU) and the score obtained from these measurements show MEWS.
Effect of MEWSS and NGA use on nursing interventions
Nursing interventions include practices such as oxygen saturation, blood pressure, pulse, respiration, body temperature, alertness, pain monitoring by nurses, positioning and giving medication.

Secondary Outcome Measures

Full Information

First Posted
October 6, 2022
Last Updated
October 6, 2023
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT05575531
Brief Title
Evaluation of the Modified Early Warning Scoring System
Official Title
The Effect of Modified Early Warning Scoring System and Nursing Guide Practices on Postoperative Patient Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 29, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
January 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

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

5. Study Description

Brief Summary
In this study, it was aimed to determine the effect of HRU and HG on patient outcomes in the care process in surgical patients followed according to MEUSS. The sample of the study, which was conducted as a randomized-controlled clinical trial, consisted of 252 patients who underwent surgical intervention under general anesthesia in a university hospital between 29 July 2022 and 31 October 2022.
Detailed Description
Postoperative patients are at risk of clinical worsening and minimizing this is vital. Nurses play a vital role in the early detection and management of clinical deterioration as they are the group of professionals with the highest patient contact. MEUSS is stated as a simple risk management tool based on physiological parameters that can allow early detection of clinical deterioration and initiation of the relevant intervention, improving the quality of care and patient safety provided to surgical patients. In this study, with a larger sample, patients will be followed up with MEUSS and a nursing guide for 2 hours in the clinic where they are transferred both after and after ASBU. Our study is a research with the highest sample in this field, in which patients are followed for the longest period of time, and it is thought that MEUSS and nursing guide applications can identify risky patients in the postoperative period and reduce postoperative complications with strict follow-up applied to these patients. The aim of this study; To determine the effect of Nursing Guide Practice (HRU) and Nursing Interventions (HG) on patient outcomes in the care process in surgical patients followed according to MEUSS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Deterioration, Postoperative Complications, Nurse's Role
Keywords
Clinical deterioration, early warning score, nursing assessment, postoperative care, surgical nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized-controlled clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
MEWSS and Nursing Guide Application will be used in the study group. MEWSS: The Modified Early Warning Score (MEWS) consists of a simple to use algorithm based on physiological parameters such as heart rate, respiratory rate, systolic blood pressure, temperature and level of consciousness. Nursing Guide Application (NGA): According to the follow-up carried out in this study: If the patient's MEWSS is 4 or below, a ten-minute follow-up was performed. If the MEWSS is five, then five-minute follow-up is passed, and if the score has not changed as a result of the follow-ups, five-minute follow-ups are continued. If the score decreased to four or less, ten-minute follow-up was started, if the score increased, five-minute follow-ups were continued, and the emergency team was informed and the patient was evaluated (the emergency team was informed about the study).
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In the control group, the patients followed according to the Modified Early Warning Scoring System received routine care in the clinic.
Intervention Type
Other
Intervention Name(s)
MEWSS and Nursing Guide Application
Intervention Description
MEWSS and Nursing Guide application will be used for the patients in the experimental group. According to the Nursing Guide application, patients with MEWS above 4 will be monitored every 5 minutes, while those with a score below 4 will be monitored for 10 minutes. will be followed intermittently. Nursing interventions will be made in accordance with the problems experienced by patients with a score above 4.
Primary Outcome Measure Information:
Title
Effects of MEWSS and NGA use on complications and clinical status
Description
Length of stay in ASBU (minutes), complications developed in ASBU, intervention time to complications (minutes), and where it was transferred after ASBU (clinical or intensive care unit)
Time Frame
From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
Title
Effect of MEWSS and NGA use on vital signs and MEWS
Description
Heart rate (beats per minute), respiratory rate (respiratory rate / min.), systolic blood pressure (mmHg), temperature (centigrade degree -°C), level of consciousness (AVPU) and the score obtained from these measurements show MEWS.
Time Frame
From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
Title
Effect of MEWSS and NGA use on nursing interventions
Description
Nursing interventions include practices such as oxygen saturation, blood pressure, pulse, respiration, body temperature, alertness, pain monitoring by nurses, positioning and giving medication.
Time Frame
From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having operated under general anesthesia transferred to the post-anesthesia care unit (ASBU) and then to the service/ICU followed for 2 hours, between 18-65 years old, who have not had an operation with general anesthesia in the last six months, no serious life-threatening complications developed during surgery, patients willing to participate in the study Exclusion Criteria: data unavailable, complications during surgery, patients who did not undergo general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda MERT, Assist.Dr.
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University Hospital
City
Kocaeli
Country
Turkey

12. IPD Sharing Statement

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Evaluation of the Modified Early Warning Scoring System

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