Postoperative Respiratory Complication, Respiratory Failure
Conditions
Brief summary
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.
Interventions
DEVICEBed 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.
Sponsors
Chiba University
Beth Israel Deaconess Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older 2. Undergoing non-cardiac surgery under general anesthesia. 3. Score ≥ 25 in the risk prediction score (Table1)
Exclusion criteria
1. Ambulatory (outpatient) surgery 2. Transfer directly to the ICU 3. Remain intubated/ planned to remain intubated after surgery 4. Pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC. 5. Patients enrolled in other interventional studies which could confound the primary endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications | First 7 postoperative days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complications | First 3 postoperative days | 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. |
| Major adverse Cardiovascular events | First 7 postoperative days | death, myocardial infarction, coronary revascularization, stroke, and heart failure. |
| Hospital length of stay | 30 days after surgery | Duration from surgery to hospital discharge |
| Adverse discharge disposition | 30 days after surgery | lost of ability to live independently: adverse discharge disposition to a skilled nursing facility or in-hospital mortality |
Countries
United States
Outcome results
None listed