NCT04736212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 29, 2021

Last Update Submit

January 3, 2023

Conditions

Postoperative Respiratory ComplicationRespiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Postoperative pulmonary complications

    First 3 postoperative days

  • Major adverse Cardiovascular events

    First 7 postoperative days

  • Hospital length of stay

    30 days after surgery

  • Adverse discharge disposition

    30 days after surgery

Interventions

Bed sensor monitoring systemDEVICE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (9)

  • 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.

    PMID: 18582931RESULT

  • 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.

    PMID: 29121283RESULT

  • 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.

    PMID: 27255952RESULT

  • 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.

    PMID: 29936327RESULT

  • 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.

    PMID: 29367198RESULT

  • 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.

    PMID: 30763161RESULT

  • 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.

    PMID: 30920886RESULT

  • 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.

    PMID: 29661384RESULT

  • 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.

    PMID: 31185781RESULT

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

March 24, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)