Assessment of Breathing Using an Under-bed Weighing Scale

NCT ID: NCT04736212

Last Updated: 2023-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-24

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Respiratory Complication Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiba University

OTHER

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maximilian S Schaefer

Assistant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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. Epub 2008 Jun 24.

Reference Type RESULT
PMID: 18582931 (View on PubMed)

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 comparing intravenous and inhalational anaesthesia. Br J Anaesth. 2017 Oct 1;119(4):655-663. doi: 10.1093/bja/aex230.

Reference Type RESULT
PMID: 29121283 (View on PubMed)

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 associated with in-hospital mortality. Resuscitation. 2016 Aug;105:123-9. doi: 10.1016/j.resuscitation.2016.05.014. Epub 2016 May 30.

Reference Type RESULT
PMID: 27255952 (View on PubMed)

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.

Reference Type RESULT
PMID: 29936327 (View on PubMed)

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 controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.

Reference Type RESULT
PMID: 29367198 (View on PubMed)

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 pneumotachography. J Appl Physiol (1985). 2019 May 1;126(5):1432-1441. doi: 10.1152/japplphysiol.00730.2018. Epub 2019 Feb 14.

Reference Type RESULT
PMID: 30763161 (View on PubMed)

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/japplphysiol.00198.2019. Epub 2019 Mar 28. No abstract available.

Reference Type RESULT
PMID: 30920886 (View on PubMed)

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 perioperative medicine: pulmonary complications. Br J Anaesth. 2018 May;120(5):1066-1079. doi: 10.1016/j.bja.2018.02.007. Epub 2018 Mar 27.

Reference Type RESULT
PMID: 29661384 (View on PubMed)

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: 10.1161/JAHA.118.010541. Epub 2019 Jun 12.

Reference Type RESULT
PMID: 31185781 (View on PubMed)

Other Identifiers

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2020P001209

Identifier Type: -

Identifier Source: org_study_id

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