Wireless Assessment of Respiratory and Circulatory Distress

NCT03491137 | Completed DMC

• 1 other identifier: H-17033535
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Postoperative Complications

Keywords

Wireless monitoring, postoperative complications

Outcome Measures

Primary Outcomes (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)

  within 30 days after inclusion

Secondary Outcomes (2)

• Mortality

  6 months postoperative

• Readmission

  6 months postoperative

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator
• Technical University of Denmark: collaborator
• Danish Cancer Society: collaborator

Study Sites (2)

Abdominal surgical department, Rigshospitalet

Copenhagen, 2200, Denmark

Location

Surgical department, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (2)

• 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.

  PMID: 35213523 DERIVED

• 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.

  PMID: 35170026 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Camilla Haahr-Raunkjær, MD

  Surgical department, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

• Eske K Aasvang, Dr.med.

  Abdominal surgical department, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, principal investigator

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: April 9, 2018
• Study Start: February 22, 2018
• Primary Completion: August 30, 2020
• Study Completion: January 31, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)