Assessment of Breathing Using an Under-bed Weighing Scale

Completed

• Conditions: Postoperative Respiratory Complication; Respiratory Failure

• Registration Number: NCT04736212
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-03-24
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hospital length of stay	30 days after surgery	Duration from surgery to hospital discharge
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.
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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States