Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor

NCT06744790 | Recruiting FDA Device

• 2 other identifiers: HCR-HP-00104773-1AGREEMENT NO. 7113
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will enroll 320 patients who will undergo non-cardiac surgery, receive supplemental oxygen via face mask, and will be on a continuous pulse oximetry monitor in the Post Anesthesia Care Unit (PACU). The enrollment criteria were adapted from a previous study that showed SpO2 values seriously underestimated the severity of post-operative hypoxemia in patients with and without specific risk factors for hypoxemia. Research personnel will screen and ensure that each subject meets the enrollment criteria, and the informed consent is properly executed. Upon arrival to the PACU, each subject will be fitted with oxygen mask containing the Linshom sensor, which will be connected to a Linshom monitor for data collection. A side stream capnography line will be connected to the same face mask and the capnography data will be collected on the Zoe Medical 740 SELECT™ monitor. Additionally, two pulse oximeters will be applied to the same hand (non- NIBP arm), one of which will be connected to a hospital monitor (SoC) and the other to a Zoe Medical 740 SELECT™ monitor. The Linshom and 740 SELECT™ monitors will collect data once every second. 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.

Conditions

Post Surgical Respiratory Failure; Respiratory Complication

Keywords

Respiratory Decline; Respiratory Complication; Respiratory Depression; Post Surgical Respiratory Failure; Continuous Monitoring; Continuous Respiratory Monitoring; respiratory; monitoring; pulse oximetry; capnography; Linshom

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of Linshom CPRM to pulse oximetry with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.

  The primary analysis will be to assess non-inferiority of Linshom to pulse oximetry with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.This analysis will be performed on patients with RDE. The statistical test to be used will be a paired t-test for non-inferiority of means.

  6-12 Months

Secondary Outcomes (1)

• Superiority of Linshom CPRM to pulse oximetry, capnography and pulse oximetry + capnography with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.

  12-24 Months

Study Arms (1)

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

Device: Linshom Continuous Predictive Respiratory Monitoring

Interventions

Linshom Continuous Predictive Respiratory Monitoring DEVICE

Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.

Also known as: Pulse Oximetry, Capnography

Post surgical (non-cardiac) PACU patients with anticipated overnight stay.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will be conducted at The University of Maryland Medical Center (UMMC) where about 9% of the surgical procedures will go to the ICU or other non-PACU location and 20% will go home same day (within 24 hours). Based on previous trial data from UMMC, investigators expect gender to be \~50% male, 76% white and 23% non-white with an age distribution of 1/3 \< 60 years of age and 2/3 \> 60 years of age. This enrollment criteria makes the study results generalizable; population balanced and supports enrollment.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linshom Medical, Inc.: lead
• Maryland Industrial Partnerships: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (11)

• 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: 27255952 BACKGROUND

• 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.

  PMID: 26362486 BACKGROUND

• 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.

  PMID: 32925318 BACKGROUND

• 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.

  PMID: 17646499 BACKGROUND

• 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.

  PMID: 20098128 BACKGROUND

• 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.

  PMID: 31598389 BACKGROUND

• 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.

  PMID: 26287299 BACKGROUND

• 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.

  PMID: 27106966 BACKGROUND

• 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.

  PMID: 31478940 BACKGROUND

• 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.

  PMID: 15539726 BACKGROUND

• 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.

  PMID: 23293275 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Oximetry; Capnography

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Samuel M Galvagno, DO, PhD, MS, MBA, FCCM

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

• LaToya Stubbs, MS, CCRC

  University of Maryland, Baltimore

  STUDY DIRECTOR

Central Study Contacts

James R Hughen, MBA

CONTACT

443-994-1448; rhughen@linshomforlife.com

Ronen Feldman, BS

CONTACT

410-480-2700; rfeldman@linshomforlife.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: June 21, 2023
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)