Wireless Assessment of Respiratory and Circulatory Distress

Postoperative Complications Clinical Trial

— WARD  

Official title:

Wireless Assessment of Respiratory and Circulatory Distress in Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491137
• Other study ID #: H-17033535
• Status: Completed
• Start date: February 22, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: October 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: January 31, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Locations

Country	Name	City	State
Denmark	Abdominal surgical department, Rigshospitalet	Copenhagen
Denmark	Surgical department, Bispebjerg Hospital	Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Danish Cancer Society, Rigshospitalet, Denmark, Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		6 months postoperative
Secondary	Readmission	Acute readmission to hospital.	6 months postoperative