Assessment of Breathing Using an Under-bed Weighing Scale

Study Overview
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Brief Summary
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The aim of this study is to assess the capability of a modified under bed weighing scale (contact-free unconstrained respiratory monitor, BSS) to predict postoperative pulmonary complications in high-risk surgical patients. The study is designed to test the hypothesis that abnormal breathing measured by a modified under bed weighing scale predicts postoperative pulmonary complications within 7 days after surgery.

Official Title
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Assessment of Breathing Using an Under-bed Weighing Scale

Conditions
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Postoperative Respiratory Complication, Respiratory Failure

Intervention / Treatment
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* Device: Bed sensor monitoring system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Undergoing non-cardiac surgery under general anesthesia. Score ≥ 25 in the risk prediction score (Table1) Exclusion Criteria: Ambulatory (outpatient) surgery Transfer directly to the ICU Remain intubated/ planned to remain intubated after surgery Pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC. Patients enrolled in other interventional studies which could confound the primary endpoint.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bed sensor monitoring system|Respiratory patterns in the post-anesthesia care unit will be assessed using a validated, modified under bed weighing scale placed under the patient's bed in the PACU.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications | atelectasis, pneumonia, acute respiratory distress syndrome, pulmonary aspiration, re-intubation, unprecedented non-invasive ventilation, unplanned ICU admission, or re-admission to the hospital due to respiratory complication. | First 7 postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications | atelectasis, pneumonia, acute respiratory distress syndrome, pulmonary aspiration, re-intubation, unprecedented non-invasive ventilation, unplanned ICU admission, or re-admission to the hospital due to respiratory complication. | First 3 postoperative days | 
| Major adverse Cardiovascular events | death, myocardial infarction, coronary revascularization, stroke, and heart failure. | First 7 postoperative days | 
| Hospital length of stay | Duration from surgery to hospital discharge | 30 days after surgery | 
| Adverse discharge disposition | lost of ability to live independently: adverse discharge disposition to a skilled nursing facility or in-hospital mortality | 30 days after surgery |