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Completed

NCT Number: NCT04736212

Assessment of Breathing Using an Under-bed Weighing Scale

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.

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Key information

Conditions

Postoperative Respiratory Complication Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Undergoing non-cardiac surgery under general anesthesia.
  • Score ≥ 25 in the risk prediction score (Table1)

Exclusion criteria

  • Ambulatory (outpatient) surgery
  • Transfer directly to the ICU
  • Remain intubated/ planned to remain intubated after surgery
  • Pregnant patients: as detected by patient self-reporting of diagnosed by preoperative pregnancy testing according to institutional policies at BIDMC.
  • Patients enrolled in other interventional studies which could confound the primary endpoint.

Treatment and study plan

Bed sensor monitoring system

Device

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Chiba University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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