NCT05575531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

October 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

October 6, 2022

Last Update Submit

October 6, 2023

Conditions

Keywords

Clinical deteriorationearly warning scorenursing assessmentpostoperative caresurgical nursing

Outcome Measures

Primary Outcomes (3)

  • 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)

    From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour

  • 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.

    From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour

  • 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.

    From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour

Study Arms (2)

Experimental Group

EXPERIMENTAL

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).

Other: MEWSS and Nursing Guide Application

Control Group

NO INTERVENTION

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

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Clinical DeteriorationPostoperative Complications

Condition Hierarchy (Ancestors)

Disease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Selda MERT, Assist.Dr.

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 12, 2022

Study Start

July 29, 2022

Primary Completion

October 31, 2022

Study Completion

January 12, 2023

Last Updated

October 10, 2023

Record last verified: 2023-03

Locations