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Postoperative ComplicationsWARDNCT03491137

Wireless Assessment of Respiratory and Circulatory Distress

An observational study of Postoperative Complications, run by Bispebjerg Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A high percentage of patients undergoing major abdominal surgery will develop a postoperative complication. Our hypothesis is that by observing postoperative patients with continuous wireless monitoring, it is possible to detect the correlation between deviating vital parameters and subsequent postoperative… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Postoperative Complications
How many people
505 participants
Where
2 sitesDenmark
Study dates
22 Feb 2018to 31 Jan 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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients enrolled for elective abdominal cancer surgery at Bispebjerg Hospital or Rigshospitalet will be invited to be a part of this study if they meet the inclusion criteria.

Who may be able to join

  • Patient > 60 years old
  • Elective operation performed at Bispebjerg Hospital or Rigshospitalet.
  • Elective major abdominal cancer surgery.
  • Operation estimated to last more than 2 hours.

Who cannot join

  • Mortality.
  • Non-cooperative patients.
  • Patients with mini mental state examination score < 24.
  • Patients allergic to plaster or silicone.
  • Patients with ICD or pacemaker

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Abdominal surgical department, Rigshospitalet

    Copenhagen, 2200

  • Surgical department, Bispebjerg Hospital

    Copenhagen, 2400

Other trials in Denmark

About this study

Official title: Wireless Assessment of Respiratory and Circulatory Distress in Surgical Patients

A high percentage of patients undergoing major abdominal surgery will develop a postoperative complication. Our hypothesis is that by observing postoperative patients with continuous wireless monitoring, it is possible to detect the correlation between deviating vital parameters and subsequent postoperative complications. A prospective observational study will take place on general surgical wards with the enrolment of 500 patients in two different hospitals. Physiological parameters will be recorded for 96 hours postoperative. Data is collected preoperative, peroperative and postoperative in up to 6 months for data analyzing.

Read the detailed description

An estimated > 230 million cases of major surgery are performed worldwide annually. Surgical interventions come with an inherent risk of complications. 15 - 30 % of all patients undergoing major abdominal surgery will develop a severe complication post-operative. These numbers correspond to the reported high postoperative in-hospital mortality, 8-9% after major upper abdominal surgery, increased in case of co-morbidities. Part of the high morbidity and mortality may be a result of delayed detection of severe complications due to the lower monitoring frequency in the general wards compared to the Post Anaesthesia Care Unit (PACU) and Intensive Care Unit (ICU). Improved observation may result in earlier detection and subsequently the possibility to implement interventions to divert a negative trajectory and ultimately reduce morbidity and mortality.

This study wish to investigate the correlation between deviating physiological parameters and postoperative complications.

In a prospective observational study, 500 patients enrolled for major abdominal cancer surgery at Rigshospitalet or Bispebjerg Hospital will be included after a signed declaration of consent.

Demographic data will be recorded together with preoperative spirometry, timed-up-and-go, Mini Mental State Examination and an electrocardiogram.

Post-operative when leaving the PACU, a wireless continuous monitoring system will be attached to the patients. The monitoring system will be recording the vital parameters 24/7.

In parallel to the wireless monitoring, the patients will receive normal treatment and monitoring (Early Warning Score) from staff on the wards. Patients are monitored for 96 hours or until they are dismissed from hospital.

Furthermore blood samples will be collected once every day for 96 hours and the patients are appointed daily by an investigator.

Exposure variables is deviation of vital parameters from normal range, socalled microevents.

Descriptive statistic will be used in analyzing the data.

Keywords
Wireless monitoring, postoperative complications
Medical subject headings
Postoperative Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any serious adverse event

    e.g cardiac arrest, ICU admission, acute myocardial infarction, sepsis, stroke, acute kidney injury, pneumonia or other serious adverse events (defined in Protocol Appendix A)

    Measured: within 30 days after inclusion

Secondary outcomes (2)

  1. Mortality

    Measured: 6 months postoperative

  2. Readmission

    Acute readmission to hospital.

    Measured: 6 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2018
  2. Study start22 Feb 2018
  3. Primary completion30 Aug 2020
  4. Study completion31 Jan 2021

Resources

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
505 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03491137
Sponsor's protocol ID
H-17033535
Acronym
WARD
Status last verified
Oct 2021
First submitted
30 Jan 2018
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan of sharing IPD to other researchers

Publications

  • Awada HN, Haahr-Raunkjaer C, Molgaard J, Rasmussen SM, Meyhoff CS, Aasvang EK. Postoperative Delirium and the Association to Continuously Monitored Severe Deviations of Vital Signs at the General Ward After Major Abdominal Surgery. Acta Anaesthesiol Scand. 2026 Nov;70(10):e70347. doi: 10.1111/aas.70347.

    PubMed 42838134

  • Jokinen JDV, Carlsson CJ, Rasmussen SM, Nielsen OW, Winkel BG, Jorgensen LN, Achiam MP, Molgaard J, Sorensen HBD, Aasvang EK, Meyhoff CS; WARD Project Group. Wireless Single-Lead ECG Monitoring to Detect New-Onset Postoperative Atrial Fibrillation in Patients After Major Noncardiac Surgery: A Prospective Observational Study. Anesth Analg. 2022 Jul 1;135(1):100-109. doi: 10.1213/ANE.0000000000005960. Epub 2022 Feb 25.

    PubMed 35213523

  • Haahr-Raunkjaer C, Molgaard J, Elvekjaer M, Rasmussen SM, Achiam MP, Jorgensen LN, Sogaard MIV, Gronbaek KK, Oxboll AB, Sorensen HBD, Meyhoff CS, Aasvang EK. Continuous monitoring of vital sign abnormalities; association to clinical complications in 500 postoperative patients. Acta Anaesthesiol Scand. 2022 May;66(5):552-562. doi: 10.1111/aas.14048. Epub 2022 Feb 28.

    PubMed 35170026

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications, run by Bispebjerg Hospital at 2 sites 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 4 inclusion and 5 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Any serious adverse event (time frame: within 30 days after inclusion). 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 NCT03491137, which also lists 3 linked publications.

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 1 Nov 2021.

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