Post Surgical Respiratory FailureNCT06744790
Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
An observational study of Post Surgical Respiratory Failure and Respiratory Complication, run by Linshom Medical, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Respiratory Failure, Respiratory Complication
- What is being tested?
- Linshom Continuous Predictive Respiratory Monitoring
- Type of treatment
- Medical device
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2023to 28 Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline
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.
Read the detailed description
Linshom Medical (Linshom) has developed the FDA-cleared Continuous Predictive Respiratory Monitor (CPRM) a small and inexpensive sensor and monitor that provides continuous real-time tracking of these critical indicators of RDE. Linshom technology is based on our novel Linshom thermal sensor which is regulated by a thermoelectric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patient's inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, relative Tidal Volume (rTV), relative Minute Ventilation (rMV), seconds since last breath (SSLB), and inspiratoryexpiratory (I/E) ratio. The CPRM solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, rTV, rMV (calculation of RR x rTV), seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care.
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.
- 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.
- Being tested
- Linshom Continuous Predictive Respiratory Monitoring
- Keywords
- Respiratory Decline, Respiratory Complication, Respiratory Depression, Post Surgical Respiratory Failure, Continuous Monitoring, Continuous Respiratory Monitoring, respiratory, monitoring, pulse oximetry, capnography, Linshom
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linshom Continuous Predictive Respiratory MonitoringDevice
Also called Pulse Oximetry, Capnography
Observational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Linshom Continuous Predictive Respiratory Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of Linshom CPRM + SOC compared to SOC alone (nurse monitoring + pulse oximetry) with respect to 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 + SOC to SOC alone (nurse monitoring + 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.
Measured: 12 Months
Secondary outcomes (1)
Superiority of Linshom CPRM + SOC to SOC alone (nurse monitoring + pulse oximetry) with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.
Under the same assumptions of mean difference and standard deviation of the paired difference as for Phase I above, but with a -1 minute noninferiority margin, then a sample size of 128 subjects with RDE has 80% power to claim noninferiority of Linshom to SOC (i.e., 80% power to reject the above null hypothesis) at a one-sided 0.025 level of significance. Assuming prevalence of RDE in the PACU population is 40%, then 320 subjects will be enrolled in Phase I and II combined to achieve128 subjects with RDE for the Phase I + II combined primary analysis.
Measured: 12-24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start21 Jun 2023
- Primary completion28 Apr 2025
- Study completion28 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Post Surgical Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Linshom Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maryland Industrial Partnerships, University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Samuel M Galvagno, DO, PhD, MS, MBA, FCCM, Principal investigator, University of Maryland, BaltimoreLaToya Stubbs, MS, CCRC, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744790
- Sponsor's protocol ID
- HCR-HP-00104773-1
- Other IDs
- AGREEMENT NO. 7113
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data and specimens will only be shared with individuals who are members of the IRB approved research team or approved for sharing as described in this IRB protocol.
Publications
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.
PubMed 27255952Andersen 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.
PubMed 26362486Khanna 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.
PubMed 32925318Overdyk 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.
PubMed 17646499Taenzer 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.
PubMed 20098128Wadhwa 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.
PubMed 31598389Sun 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.
PubMed 26287299Khanna 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.
PubMed 27106966May 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.
PubMed 31478940Fu 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.
PubMed 15539726Niesters 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.
PubMed 23293275
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linshom Continuous Predictive Respiratory Monitor (CPRM) for Prediction of Patient Respiratory Decline
- ClinicalTrials.gov ID
- NCT06744790
- Acronym / sponsor ID
- HCR-HP-00104773-1
- Keywords
- Respiratory Decline, Respiratory Complication, Respiratory Depression, Post Surgical Respiratory Failure, Continuous Monitoring, Continuous Respiratory Monitoring, respiratory, monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Linshom Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Maryland Industrial Partnerships, University of Maryland, Baltimore
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Jun 2025 (actual)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Linshom Medical (Linshom) has developed the FDA-cleared Continuous Predictive Respiratory Monitor (CPRM) a small and inexpensive sensor and monitor that provides continuous real-time tracking of these critical indicators of RDE. Linshom technology is based on our novel Linshom thermal sensor which is regulated by a thermoelectric cooler utilizing a proprietary control loop process. Respiration state is measured via temperature change throughout a patient's inspiratory/expiratory cycle. This delivers a respiratory signature allowing for continuous measurement of RR, relative Tidal Volume (rTV), relative Minute Ventilation (rMV), seconds since last breath (SSLB), and inspiratoryexpiratory (I/E) ratio. The CPRM solves existing unmet needs mentioned above with a small, portable, and inexpensive sensor and monitor that tracks RR, rTV, rMV (calculation of RR x rTV), seconds since last breath (SSLB), and I:E ratio in real time and continuously. These parameters are crucial in monitoring of patients suffering from both acute and chronic respiratory illness. Linshom offers an OR-quality respiratory profile at the patient bedside, which allows health care providers to promptly diagnose emerging respiratory decline and intervene with appropriate medical care.
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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post surgical (non-cardiac) PACU patients with anticipated overnight stay. | – | Device: Linshom Continuous Predictive Respiratory MonitoringIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linshom Continuous Predictive Respiratory MonitoringAlso: Pulse Oximetry, CapnographyObservational study. Monitoring of Linshom, pulse oximetry and capnography data with comparison to current standard of care. | Device | Post surgical (non-cardiac) PACU patients with anticipated overnight stay. |
Primary outcome
Non-inferiority of Linshom CPRM + SOC compared to SOC alone (nurse monitoring + pulse oximetry) with respect to time (in minutes) prior to RDE that it was predicted that an RDE would occur.
Time frame: 12 Months
The primary analysis will be to assess non-inferiority of Linshom + SOC to SOC alone (nurse monitoring + 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.
1 secondary outcome
Superiority of Linshom CPRM + SOC to SOC alone (nurse monitoring + pulse oximetry) with respect to the time (in minutes) prior to RDE that it was predicted that an RDE would occur.
Time frame: 12-24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Results publication: PubMed 27255952Andersen 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.
- Results publication: PubMed 26362486Andersen 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.
- Results publication: PubMed 32925318Khanna 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.
- Results publication: PubMed 17646499Overdyk 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.
- Results publication: PubMed 20098128Taenzer 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.
- Results publication: PubMed 31598389Wadhwa 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.
- Results publication: PubMed 26287299Sun 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.
- Results publication: PubMed 27106966Khanna 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.
- Results publication: PubMed 31478940May 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.
- Results publication: PubMed 15539726Fu 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.
- Results publication: PubMed 23293275Niesters 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.
- Individual participant dataSharing planned: No. Data and specimens will only be shared with individuals who are members of the IRB approved research team or approved for sharing as described in this IRB protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel M Galvagno, DO, PhD, MS, MBA, FCCM principal investigator
University of Maryland, Baltimore
LaToya Stubbs, MS, CCRC study director
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Surgical Respiratory Failure and Respiratory Complication, run by Linshom Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of Linshom CPRM + SOC compared to SOC alone (nurse monitoring + pulse oximetry) with respect to time (in minutes) prior to RDE that it was predicted that an RDE would occur. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06744790, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.