Clinical trial NCT03491137: Wireless Assessment of Respiratory and Circulatory Distress
Official title: Wireless Assessment of Respiratory and Circulatory Distress in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Keywords: Wireless monitoring, postoperative complications
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Technical University of Denmark
name: Danish Cancer Society
First posted: 2018-04-09
Enrollment: 505
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Any serious adverse event
timeFrame: within 30 days after inclusion
Secondary outcomes:
measure: Mortality
timeFrame: 6 months postoperative
measure: Readmission
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Abdominal surgical department, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Surgical department, Bispebjerg Hospital
Study officials:
affiliation: Surgical department, Bispebjerg Hospital
name: Camilla Haahr-Raunkjær, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abdominal surgical department, Rigshospitalet
name: Eske K Aasvang, Dr.med.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.