Wireless Assessment of Respiratory and Circulatory Distress

NCT ID: NCT03491137

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 505 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Postoperative Complications

Keywords

Wireless monitoring, postoperative complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Technical University of Denmark

OTHER

Sponsor Role: collaborator

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Camilla Haahr-Raunkjær

MD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Camilla Haahr-Raunkjær, MD

Role: PRINCIPAL_INVESTIGATOR

Surgical department, Bispebjerg Hospital

Eske K Aasvang, Dr.med.

Role: STUDY_CHAIR

Abdominal surgical department, Rigshospitalet

Locations

Abdominal surgical department, Rigshospitalet

Copenhagen, , Denmark

Surgical department, Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 35213523 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35170026 (View on PubMed)

Other Identifiers

H-17033535

Identifier Type: -

Identifier Source: org_study_id