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Assessment of Breathing Using an Under-bed Weighing Scale

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ClinicalTrials.gov Identifier: NCT04736212
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Chiba University
Information provided by (Responsible Party):
Maximilian S Schaefer, Beth Israel Deaconess Medical Center

Study Description
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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
Postoperative Respiratory Complication Respiratory Failure Device: Bed sensor monitoring system

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Major adverse Cardiovascular events [ Time Frame: First 7 postoperative days ]
    death, myocardial infarction, coronary revascularization, stroke, and heart failure.

  3. Hospital length of stay [ Time Frame: 30 days after surgery ]
    Duration from surgery to hospital discharge

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736212


Contacts
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Contact: Maximilian Schaefer, M.D. 617-667-3112 msschaef@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Maximilian S Schaefer, MD    617-632-0728    msschaef@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Chiba University
More Information
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Publications of Results:

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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: February 3, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases