Pain, PostoperativeNCT03438578
Efficacy Safety Score in Postoperative Management
A study testing Efficacy Safety Score monitoring in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- Efficacy Safety Score monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 5 Mar 2018to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- undergoing surgery
- expectedly to be treated and observed in hospital for more than 24 hours postoperatively
Who cannot join
- refusal of participation
- poor communication capabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
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.
- Being tested
- Efficacy Safety Score monitoring
- Keywords
- Patient safety, Postoperative care, Monitoring, physiologic, Safety management
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy Safety Score monitoringDevice
Also called Isansys, Patient Gateway System
According to data gathered from ESS and monitoring, the patients will receive needed care.
| Study group | Role | What they receive |
|---|---|---|
| Efficacy Safety Score monitoring | Experimental | Patients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward Receives: Device: Efficacy Safety Score monitoring |
| Regular | No intervention | Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Mobilization
The measured postoperative time when patient can stand and able to walk one or more steps, with or without support
Measured: 24 hours
Secondary outcomes (2)
Pain Measurement, Verbal Numeric Rating Scale
Reported pain hourly on a 11-digit scale, called Verbal Numeric Rating Scale for pain, 0-10 where 0 is no pain, and 10 is worst thinkable pain. Higher scores mean a worse outcome.
Measured: 24 hours
Patient Satisfaction
Reported patient satisfaction on a 1-5 scale, (Likert scale), where 1 is Very dissatisfied, and 5 is Very satisfied. Higher scores mean a better outcome.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start5 Mar 2018
- Primary completion18 Oct 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Johan Raeder, Prof, Study director, University of OsloErik Solligård, MD PhD, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438578
- Sponsor's protocol ID
- 2017/1903
- Status last verified
- Sep 2020
- First submitted
- 13 Feb 2018
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31608431
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Efficacy Safety Score in Postoperative Management: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03438578
- Acronym / sponsor ID
- 2017/1903
- Keywords
- Patient safety, Postoperative care, Monitoring, physiologic, Safety management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efficacy Safety Score monitoring | Experimental | Device: Efficacy Safety Score monitoringPatients monitored with wireless vital signs and Efficacy Safety Score after discharge from the post-anesthesia care unit to an ordinary ward |
| Regular | No intervention | –Patients receiving standard postoperative care after discharge from the post-anesthesia care unit to an ordinary ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing surgery
- expectedly to be treated and observed in hospital for more than 24 hours postoperatively
Key exclusion criteria (2 listed)
- refusal of participation
- poor communication capabilities
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 |
|---|---|---|
| Efficacy Safety Score monitoringAlso: Isansys, Patient Gateway SystemAccording to data gathered from ESS and monitoring, the patients will receive needed care. | Device | Efficacy Safety Score monitoring |
Primary outcome
Time to Mobilization
Time frame: 24 hours
The measured postoperative time when patient can stand and able to walk one or more steps, with or without support
2 secondary outcomes
Pain Measurement, Verbal Numeric Rating Scale
Time frame: 24 hours
Patient Satisfaction
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31608431Skraastad 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.
- Individual participant dataSharing planned: No
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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.
Johan Raeder, Prof study director
University of Oslo
Erik Solligård, MD PhD study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy Safety Score monitoring in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 2 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 24 Sep 2020. 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 Norway. 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?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Mobilization (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438578, which also lists 1 linked publication.
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 24 Sep 2020.