Oncologic Complications and EmergenciesMEWSNCT02336828
Validation of Modified Early Warning Score (MEWS) in Predicting Outcomes in Clinical Oncology Ward Adult Patients
An observational study of Oncologic Complications and Emergencies and Cancer, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This study is to validate the use of the modified early warning score (MEWS) in an adult oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will be associated with an increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Complications and Emergencies, Cancer, Emergencies
- How many people
- 171 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Mar 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical oncology ward adult patients
Who may be able to join
- The patients consecutively admitted to clinical oncology ward from 18 January to 7 February 2015 are included in the study.
Who cannot join
- The patients with incomplete MEWS or discharge data are excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong
Hang Ching Au
About this study
This study is to validate the use of the modified early warning score (MEWS) in an adult oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will be associated with an increased risk of death or ICU admission, and should be regarded as a MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and aggressive management of life-threatening complications in oncology patients, results in dramatic improvements in overall survival rates.
This is a prospective, single centre, observational, cohort study. Objective of this study is to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day mortality in adult clinical oncology ward patients.
Read more
The alternate hypothesis of this study is a significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.
The null hypothesis is a no significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.
The primary outcome measure in this study is the number of patients who die within 7 days of a MEWS Alarm (7 day mortality).
The secondary outcome measure in this study is the number of patients admitted to ICU within 7 days of a MEWS Alarm.
Read the detailed description
This study will be conducted in a 26-bedded clinical oncology ward, a university teaching hospital in the Hong Kong Island of Hong Kong.
The patients consecutively admitted to clinical oncology ward from 18 January to 7 February 2015 are included in the study, the patients was counted 7 day mortality or 7 day ICU admission from the on set of reaching the MEWS Alarm. The patients with incomplete MEWS or discharge data are excluded.
A pilot study was conducted from 13 July at the time of 0am to 18 July at the time of 0am, 2014, 41 patients were admitted consecutively to the clinical oncology ward during the study period. 10 of them were excluded because of their incomplete MEWS chart, leaving 31 patients in the pilot study. 18 of them are male and 13 of them are female. 1 patient was transfer to ICU on her second day from admission, as the MEWS score increased by 3 from initial. Six patients had 7 day mortality with MEWS alarm and one patient had 7 day mortality without MEWS alarm in the study period. According to the sample size formulas and the calculators, the estimated sampling is 171 patients from 18 January to 7 February 2015.
MEWS is a standard nursing routine measurement by calculating the sum of five physiological parameters: systolic blood pressure, pulse rate, respiratory rate, body temperature and level of consciousness. The calculated MEWS score is being charted on an observation chart sheet. Nursing staff routinely collect MEWS score on admission and then once every day during hospital stay. The date of admission to ICU, and date of death are also collected .
In detail, blood pressure and pulse rate are measured electronically (Dinamap Pro 200 Critikon Vital Signs Monitor, U.S.A). The respiratory rate is counted over one minute. The tympanic temperature is recorded (ThermoScan, Type 6014, Braun, Germany), and the level of consciousness is based on the AVPU score: A is 'alert', V is 'response to verbal', P is 'response to pain' and U for 'unresponsive').
The MEWS score is counterchecked by doctors after doctors' assessment on admission and at the doctors' round everyday.
An ethical approval will be acquired from the CUHK and Queen Mary Hospital Clinical Research Ethics Committee. All the participants involved in the study will not experience any harm. Potential participants will be given written information regarding the nature of the study and the assurances confidentiality for the data collected. Written Consent will be signed. All report copies collected will be kept confidential. Patient can choose whether or not to be in this study. If they volunteer to be in this study, they may withdraw at any time without consequences of any kind of loss or benefits.
For data analysis, the 7 day mortality with reaching MEWS Alarm will compare with the ones without reaching MEWS Alarm by Chi-Squared Test. The relationship between MEWS and the mortality is statistically significant if the P value is lower than 0.05. Besides, same method of data analysis is used on ICU admission with or without reaching MEWS Alarm.
- Conditions
- Oncologic Complications and Emergencies, Cancer, Emergencies
- Keywords
- MEWS, deteriorate, oncology, ICU, predicting outcomes, MEWS in predicting outcomes in oncology patients
- Medical subject headings
- Emergencies, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MEWS alarm and mortality | Reach MEWS Alarm, Not reach MEWS Alarm, With 7 day mortality, Without 7 day mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who die within 7 days of a MEWS Alarm (7 day mortality).
Measured: The 7 day mortality was counted from the on set of reaching the MEWS Alarm
Secondary outcomes (1)
The number of patients admitted to ICU within 7 days of a MEWS Alarm.
Measured: The 7 day ICU admission was counted from the on set of reaching the MEWS Alarm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic Complications and EmergenciesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Au Hang Ching, Chinese University of Hong Kong
- Investigators
- AU HANG CHING, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336828
- Sponsor's protocol ID
- 1155044283
- Acronym
- MEWS
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Modified Early Warning Score (MEWS) in Predicting Outcomes in Clinical Oncology Ward Adult Patients
- ClinicalTrials.gov ID
- NCT02336828
- Acronym / sponsor ID
- MEWS / 1155044283
- Conditions
- Oncologic Complications and Emergencies, Cancer, Emergencies
- Keywords
- MEWS, deteriorate, oncology, ICU, predicting outcomes, MEWS in predicting outcomes in oncology patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- 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.
This study is to validate the use of the modified early warning score (MEWS) in an adult oncology ward as a predictor of 7 day mortality or intensive care unit (ICU) admission. It is expected that either a MEWS score ≥4 or a change in score of ≥2 from the initial reading will be associated with an increased risk of death or ICU admission, and should be regarded as a MEWS Alarm. If MEWS is proof to be a reliable alternative tool, early diagnosis and aggressive management of life-threatening complications in oncology patients, results in dramatic improvements in overall survival rates.
This is a prospective, single centre, observational, cohort study. Objective of this study is to investigate the ability of the Modified Early Warning Score (MEWS) to predict 7 day mortality in adult clinical oncology ward patients.
The alternate hypothesis of this study is a significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.
The null hypothesis is a no significant difference in 7 day mortality between adult oncology ward patients with a MEWS Alarm and adult oncology ward patients without a MEWS alarm.
The primary outcome measure in this study is the number of patients who die within 7 days of a MEWS Alarm (7 day mortality).
The secondary outcome measure in this study is the number of patients admitted to ICU within 7 days of a MEWS Alarm.
Detailed description
This study will be conducted in a 26-bedded clinical oncology ward, a university teaching hospital in the Hong Kong Island of Hong Kong.
The patients consecutively admitted to clinical oncology ward from 18 January to 7 February 2015 are included in the study, the patients was counted 7 day mortality or 7 day ICU admission from the on set of reaching the MEWS Alarm. The patients with incomplete MEWS or discharge data are excluded.
A pilot study was conducted from 13 July at the time of 0am to 18 July at the time of 0am, 2014, 41 patients were admitted consecutively to the clinical oncology ward during the study period. 10 of them were excluded because of their incomplete MEWS chart, leaving 31 patients in the pilot study. 18 of them are male and 13 of them are female. 1 patient was transfer to ICU on her second day from admission, as the MEWS score increased by 3 from initial. Six patients had 7 day mortality with MEWS alarm and one patient had 7 day mortality without MEWS alarm in the study period. According to the sample size formulas and the calculators, the estimated sampling is 171 patients from 18 January to 7 February 2015.
MEWS is a standard nursing routine measurement by calculating the sum of five physiological parameters: systolic blood pressure, pulse rate, respiratory rate, body temperature and level of consciousness. The calculated MEWS score is being charted on an observation chart sheet. Nursing staff routinely collect MEWS score on admission and then once every day during hospital stay. The date of admission to ICU, and date of death are also collected .
In detail, blood pressure and pulse rate are measured electronically (Dinamap Pro 200 Critikon Vital Signs Monitor, U.S.A). The respiratory rate is counted over one minute. The tympanic temperature is recorded (ThermoScan, Type 6014, Braun, Germany), and the level of consciousness is based on the AVPU score: A is 'alert', V is 'response to verbal', P is 'response to pain' and U for 'unresponsive').
The MEWS score is counterchecked by doctors after doctors' assessment on admission and at the doctors' round everyday.
An ethical approval will be acquired from the CUHK and Queen Mary Hospital Clinical Research Ethics Committee. All the participants involved in the study will not experience any harm. Potential participants will be given written information regarding the nature of the study and the assurances confidentiality for the data collected. Written Consent will be signed. All report copies collected will be kept confidential. Patient can choose whether or not to be in this study. If they volunteer to be in this study, they may withdraw at any time without consequences of any kind of loss or benefits.
For data analysis, the 7 day mortality with reaching MEWS Alarm will compare with the ones without reaching MEWS Alarm by Chi-Squared Test. The relationship between MEWS and the mortality is statistically significant if the P value is lower than 0.05. Besides, same method of data analysis is used on ICU admission with or without reaching MEWS Alarm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEWS alarm and mortality | – | –Reach MEWS Alarm, Not reach MEWS Alarm, With 7 day mortality, Without 7 day mortality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical oncology ward adult patients
Key inclusion criteria (1 listed)
- The patients consecutively admitted to clinical oncology ward from 18 January to 7 February 2015 are included in the study.
Key exclusion criteria (1 listed)
- The patients with incomplete MEWS or discharge data are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients who die within 7 days of a MEWS Alarm (7 day mortality).
Time frame: The 7 day mortality was counted from the on set of reaching the MEWS Alarm
1 secondary outcome
The number of patients admitted to ICU within 7 days of a MEWS Alarm.
Time frame: The 7 day ICU admission was counted from the on set of reaching the MEWS Alarm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
AU HANG CHING principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncologic Complications and Emergencies and Cancer, run by Chinese University of Hong Kong at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2015. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AU HANG CHING ((+852)64060129, au1119@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who die within 7 days of a MEWS Alarm (7 day mortality). (time frame: The 7 day mortality was counted from the on set of reaching the MEWS Alarm). 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 26 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.