Complication of Surgical ProcedureWARD-VASCNCT04628858
Wireless Assessment of Respiratory and Circulatory Distress in Vascular Surgical Patients - An Observational Study
An observational study of Complication of Surgical Procedure and Complication of Anesthesia, run by Eske Kvanner Aasvang at 1 site in Denmark.
Trial summary
Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities. After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Surgical Procedure, Complication of Anesthesia, Respiratory Complication
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2020to 23 Jul 2021
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 patients admitted for elective or subacute vascular surgical intervention, as noted in the inclusion criteria, will be included on the day before their surgical procedure.
Who may be able to join
- Patients admitted to Copenhagen University Hospital
- Patients with Peripheral Arteriel Disease(PAD)
- Patients undergoing open infraligamentary revascularization
- Emergency or subacute surgery
- Admission the day before surgery, and expected length of stay more than 2 days.
Who cannot join
- Patient expected not to cooperate
- Patients with dementia or not able to give informed consent
- Patient allergic to plaster, plastic or silicone
- Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
- Patients in isolation
- Active therapy withdrawn
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- Patients previously included in the other study branches
- Patients with >20 mmHg in difference in systolic blood pressure between the two arms.
- Expected discharge within less than 24 hours from possible inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study
Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.
After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.
Read more
Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.
Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'
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 |
|---|---|---|
| Primary group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic abnormal vital signs - Cumulative duration
Cumulative duration of physiologic vital signs within certain thresholds outside normalcy
Measured: From inclusion until 4 days or discharge
Secondary outcomes (1)
Physiologic abnormal vital signs - Episodes of sustained duration
Episodes of sustained duration of physiologic vital signs within certain thresholds outside normalcy, with different minimum durations
Measured: From inclusion until 4 days or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start17 Aug 2020
- Primary completion23 Jan 2021
- Study completion23 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Eske Kvanner Aasvang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske K Aasvang, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628858
- Sponsor's protocol ID
- H-19086583
- Acronym
- WARD-VASC
- Status last verified
- Apr 2022
- First submitted
- 9 Nov 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Physiological Parameters for Early Detection of Complications in Postoperative Vascular Surgical Patients - An Observational Study
- ClinicalTrials.gov ID
- NCT04628858
- Acronym / sponsor ID
- WARD-VASC / H-19086583
- Conditions
- Complication of Surgical Procedure, Complication of Anesthesia, Respiratory Complication, Circulatory; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eske Kvanner AasvangUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 23 Jan 2021 (actual)
- Study completion
- 23 Jul 2021 (actual)
- First posted
- 16 Nov 2020 (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.
Vascular postsurgical patients have a high risk of morbidity and mortality. On top of that, patients undergoing vascular surgery usually have a high burden of comorbidities.
After a short stay in the post-operative ward, patients are usually transferred to a standard surgical ward.
Monitoring of physiological parameters by intermittent manual recordings 8-12 hours apart, is today's standard of care in hospitals. However, no effect on length of hospital stay, morbidity or mortality has been proven. This may be due to the up to 12 hours of unobserved time that can occur, where physiological deviations can progress resulting in clinical adverse outcomes such as myocardial infarction or stroke.
Vital sign micro events are occurrences when patient physiological parameters deviates significantly from what can be understood as normal physiology. Since adverse outcomes in patients rarely happens without deviating physiological parameters, it is to be investigated if micro events can be used to predict clinical adverse outcomes to patients. We acknowledge that during the observation period, the number of false alarms should be kept to a minimum to avoid the risk of 'alarm fatigue'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients admitted for elective or subacute vascular surgical intervention, as noted in the inclusion criteria, will be included on the day before their surgical procedure.
Key inclusion criteria (5 listed)
- Patients admitted to Copenhagen University Hospital
- Patients with Peripheral Arteriel Disease(PAD)
- Patients undergoing open infraligamentary revascularization
- Emergency or subacute surgery
- Admission the day before surgery, and expected length of stay more than 2 days.
Key exclusion criteria (9 listed)
- Patient expected not to cooperate
- Patients with dementia or not able to give informed consent
- Patient allergic to plaster, plastic or silicone
- Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
- Patients in isolation
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
Physiologic abnormal vital signs - Cumulative duration
Time frame: From inclusion until 4 days or discharge
Cumulative duration of physiologic vital signs within certain thresholds outside normalcy
1 secondary outcome
Physiologic abnormal vital signs - Episodes of sustained duration
Time frame: From inclusion until 4 days or discharge
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 27 Apr 2022.
- 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.
Eske K Aasvang study director
Copenhagen University Hospital, Rigshospitalet
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 Complication of Surgical Procedure and Complication of Anesthesia, run by Eske Kvanner Aasvang at 1 site in Denmark.
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 5 inclusion and 9 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 27 Apr 2022. 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 Denmark. 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?
Physiologic abnormal vital signs - Cumulative duration (time frame: From inclusion until 4 days or discharge). 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 27 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.