Assessment of Breathing Using an Under-bed Weighing Scale

January 3, 2023 updated by: Maximilian S Schaefer, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

We anticipate that our study population will reflect the normal distribution of race and gender of patients presenting for surgeries at BIDMC.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: 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.
First 7 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pulmonary complications
Time Frame: 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.
First 3 postoperative days
Major adverse Cardiovascular events
Time Frame: First 7 postoperative days
death, myocardial infarction, coronary revascularization, stroke, and heart failure.
First 7 postoperative days
Hospital length of stay
Time Frame: 30 days after surgery
Duration from surgery to hospital discharge
30 days after surgery
Adverse discharge disposition
Time Frame: 30 days after surgery
lost of ability to live independently: adverse discharge disposition to a skilled nursing facility or in-hospital mortality
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

Chiba University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020P001209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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