Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
NCT ID: NCT06744790
Last Updated: 2024-12-20
Study Results
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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RECRUITING
320 participants
OBSERVATIONAL
2023-06-21
2025-06-16
Brief Summary
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Research personnel will then initiate the Linshom CPRM baseline mode and begin recording any clinical intervention (e.g., medications, oxygen delivery change, and stimulation upon detection of changes in patient's condition) that is performed by the PACU staff, paying close attention to, and recording of time at which those interventions occurred. Data collection will be performed throughout the subject's entire PACU stay. The CPRM data collection will be performed passively while the patient is monitored via SoC and will not interfere with clinical interventions that may take place during the data collection. Clinical staff in the PACU will be blinded to the Linshom CPRM data as well as pulse oximetry (non-SOC monitor) and capnography data collected.
Detailed Description
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In Phase I, investigators will conduct a clinical study in 145 post-operative patients comparing Linshom's CPRM to current SOC (clinical attention + pulse oximetry) and capnography. We will collect SOC, CPRM and capnography data simultaneously from each patient to demonstrate the ability of Linshom CPRM to identify Respiratory Depression Episodes in advance of SOC and/or capnography.
In Phase II, investigators will conduct a continuation of the phase I clinical study until the enrollment for this phase (175 patients) is reached, which would give an adequate statistical power for development of the Linshom CPRM alarm function.
Specific aims:
Aim 1: Demonstrate that Linshom CPRM is able to identify RDE earlier than pulse oximetry and capnography.
o Outcome: Investigators expect to successfully demonstrate that Linshom CPRM is capable of identifying RDE in advance of pulse oximetry and capnography by performing statistical analyses (non-inferiority and superiority hypothesis tests).
Aim 2: Identify parameters and threshold values for the alarm function of Linshom CPRM for RR, rTV percent change, rMV percent change, I:E ratio and SSLB.
Outcome: Investigators will identify Linshom CPRM parameters and threshold values with high predictive abilities for RDE. These parameters and threshold values will be incorporated into future product to alert for clinicians and allow them to provide timely interventions to patients.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Post surgical (non-cardiac) PACU patients with anticipated overnight stay.
In this study investigators will recruit patients that meet the following criteria:
Inclusion Criteria:
≥18 years old undergoing non-cardiac surgery Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight Receiving supplemental oxygen via face mask in the PACU On continuous SpO2 saturation monitoring Receiving standard postoperative of care
Exclusion Criteria:
Requirement for any form of postoperative invasive ventilatory support Patients receiving only local or topical anesthesia Day/outpatient surgery Unable to cooperate with the application of the study device Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
Linshom Continuous Predictive Respiratory Monitoring
Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.
Interventions
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Linshom Continuous Predictive Respiratory Monitoring
Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Post-operative patients admitted to the PACU and expected to stay in the hospital for at least overnight
* Receiving supplemental oxygen via face mask in the PACU
* On continuous SpO2 saturation monitoring
* Receiving standard postoperative of care
Exclusion Criteria
* Patients receiving only local or topical anesthesia
* Day/outpatient surgery
* Unable to cooperate with the application of the study device
* Surgical/nursing/anesthesia staff suggest no study-related monitoring because of medical situation
18 Years
ALL
No
Sponsors
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Maryland Industrial Partnerships
OTHER
University of Maryland, Baltimore
OTHER
Linshom Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel M Galvagno, DO, PhD, MS, MBA, FCCM
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
LaToya Stubbs, MS, CCRC
Role: STUDY_DIRECTOR
University of Maryland, Baltimore
Locations
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University of Maryland Medical Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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References
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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.
Andersen LW, Kim WY, Chase M, Berg KM, Mortensen SJ, Moskowitz A, Novack V, Cocchi MN, Donnino MW; American Heart Association's Get With the Guidelines((R)) - Resuscitation Investigators. The prevalence and significance of abnormal vital signs prior to in-hospital cardiac arrest. Resuscitation. 2016 Jan;98:112-7. doi: 10.1016/j.resuscitation.2015.08.016. Epub 2015 Sep 9.
Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.
Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.
Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b.
Wadhwa V, Gonzalez AJ, Selema K, Feldman R, Lopez R, Vargo JJ. Novel device for monitoring respiratory rate during endoscopy-A thermodynamic sensor. World J Gastrointest Pharmacol Ther. 2019 Jul 18;10(3):57-66. doi: 10.4292/wjgpt.v10.i3.57.
Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.
Khanna AK, Sessler DI, Sun Z, Naylor AJ, You J, Hesler BD, Kurz A, Devereaux PJ, Saager L. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br J Anaesth. 2016 May;116(5):632-40. doi: 10.1093/bja/aew029.
May AM, Kazakov J, Strohl KP. Predictors of Intraprocedural Respiratory Bronchoscopy Complications. J Bronchology Interv Pulmonol. 2020 Apr;27(2):135-141. doi: 10.1097/LBR.0000000000000619.
Fu ES, Downs JB, Schweiger JW, Miguel RV, Smith RA. Supplemental oxygen impairs detection of hypoventilation by pulse oximetry. Chest. 2004 Nov;126(5):1552-8. doi: 10.1378/chest.126.5.1552.
Niesters M, Mahajan RP, Aarts L, Dahan A. High-inspired oxygen concentration further impairs opioid-induced respiratory depression. Br J Anaesth. 2013 May;110(5):837-41. doi: 10.1093/bja/aes494. Epub 2013 Jan 4.
Other Identifiers
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AGREEMENT NO. 7113
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HCR-HP-00104773-1
Identifier Type: -
Identifier Source: org_study_id