Assessment of Breathing Using an Under-bed Weighing Scale

Respiratory Failure Clinical Trial

Official title:

Assessment of Breathing Using an Under-bed Weighing Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736212
• Other study ID #: 2020P001209
• Status: Completed
• Start date: March 24, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Respiratory Complication
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Chiba University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Abbott TEF, Fowler AJ, Pelosi P, Gama de Abreu M, Moller AM, Canet J, Creagh-Brown B, Mythen M, Gin T, Lalu MM, Futier E, Grocott MP, Schultz MJ, Pearse RM; StEP-COMPAC Group. A systematic review and consensus definitions for standardised end-points in pe — View Citation

Andersen LW, Berg KM, Chase M, Cocchi MN, Massaro J, Donnino MW; American Heart Association's Get With The Guidelines((R))-Resuscitation Investigators. Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors — View Citation

Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised cont — View Citation

Choi BG, Rha SW, Yoon SG, Choi CU, Lee MW, Kim SW. Association of Major Adverse Cardiac Events up to 5 Years in Patients With Chest Pain Without Significant Coronary Artery Disease in the Korean Population. J Am Heart Assoc. 2019 Jun 18;8(12):e010541. doi — View Citation

de la Gala F, Pineiro P, Reyes A, Vara E, Olmedilla L, Cruz P, Garutti I. Postoperative pulmonary complications, pulmonary and systemic inflammatory responses after lung resection surgery with prolonged one-lung ventilation. Randomized controlled trial co — View Citation

Isono S, Nozaki-Taguchi N, Hasegawa M, Kato S, Todoroki S, Masuda S, Iida N, Nishimura T, Noto M, Sato Y. Contact-free unconstraint respiratory measurements with load cells under the bed in awake healthy volunteers: breath-by-breath comparison with pneumo — View Citation

Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18. — View Citation

Schaefer MS, Eikermann M. Contact-free respiratory monitoring using bed wheel sensors: a valid respiratory monitoring technique with significant potential impact on public health. J Appl Physiol (1985). 2019 May 1;126(5):1430-1431. doi: 10.1152/japplphysi — View Citation

Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epu — View Citation

Outcome

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