Clinical DeteriorationNCT05575531
Evaluation of the Modified Early Warning Scoring System
A study testing MEWSS and Nursing Guide Application in people with Clinical Deterioration and Postoperative Complications, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Deterioration, Postoperative Complications, Nurse's Role
- What is being tested?
- MEWSS and Nursing Guide Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2022to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- data unavailable,
- complications during surgery,
- patients who did not undergo general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Modified Early Warning Scoring System and Nursing Guide Practices on Postoperative Patient Outcomes
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.
Read the 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.
- Being tested
- MEWSS and Nursing Guide Application
- Keywords
- Clinical deterioration, early warning score, nursing assessment, postoperative care, surgical nursing
- Medical subject headings
- Clinical Deterioration, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEWSS and Nursing Guide ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start29 Jul 2022
- Primary completion31 Oct 2022
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DeteriorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized-controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELDA MERT, Kocaeli University
- Investigators
- Selda MERT, Assist.Dr., Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575531
- Sponsor's protocol ID
- KAEK/17.bI.02
- Status last verified
- Mar 2023
- First submitted
- 6 Oct 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Modified Early Warning Scoring System and Nursing Guide Practices on Postoperative Patient Outcomes
- ClinicalTrials.gov ID
- NCT05575531
- Acronym / sponsor ID
- KAEK/17.bI.02
- Keywords
- Clinical deterioration, early warning score, nursing assessment, postoperative care, surgical nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: MEWSS and Nursing Guide ApplicationMEWSS 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). |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- data unavailable,
- complications during surgery,
- patients who did not undergo general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEWSS and Nursing Guide ApplicationMEWSS 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. | Other | Experimental Group |
Primary outcome
Effects of MEWSS and NGA use on complications and clinical status
Time frame: From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
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
Time frame: From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
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
Time frame: From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour
Nursing interventions include practices such as oxygen saturation, blood pressure, pulse, respiration, body temperature, alertness, pain monitoring by nurses, positioning and giving medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda MERT, Assist.Dr. principal investigator
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEWSS and Nursing Guide Application in people with Clinical Deterioration and Postoperative Complications, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of MEWSS and NGA use on complications and clinical status (time frame: From the first 5 minutes when the patient comes to the post-anesthesia care unit to the end of the second hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.