Assessment of Breathing Using an Under-bed Weighing Scale

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04736212
• Collaborator: Chiba University (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 18.3
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Respiratory Complication; Respiratory Failure	Device: Bed sensor monitoring system

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Breathing Using an Under-bed Weighing Scale
• Actual Study Start Date: Mar 24, 2021
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Major adverse Cardiovascular events [First 7 postoperative days]

   death, myocardial infarction, coronary revascularization, stroke, and heart failure.

3. Hospital length of stay [30 days after surgery]

   Duration from surgery to hospital discharge

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• Chiba University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maximilian S Schaefer, Assistant Professor of Anesthesia, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04736212
• Other Study ID Numbers: 2020P001209
• First Posted: Feb 3, 2021
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Sep 24, 2021