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NCT06744790 · ClinicalTrials.gov registry record
Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor
A clinical trial of Respiratory Complication and Post Surgical Respiratory Failure, sponsored by Linshom Medical.
- Recruiting
- Registry status
- 320
- Enrollment target
- 1
- Study location
NCT06744790 is a study of Respiratory Complication and Post Surgical Respiratory Failure that is actively recruiting participants, run by Linshom Medical. The registered enrollment target is 320 participants, above the 36-participant average among 3 other Respiratory Complication trials with a reported enrollment target (789% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06744790, a study of Respiratory Complication and Post Surgical Respiratory Failure, is actively recruiting participants, sponsored by Linshom Medical.
- RECRUITING
- Registry status
- 320 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Linshom Continuous Predictive Respiratory Monitoring
Study Locations (1)
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2023-06-21 |
| Est. Completion | 2025-06-16 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06744790
The ClinicalTrials.gov registry entry for NCT06744790 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 36-participant average among 3 other Respiratory Complication trials with a reported enrollment target (789% higher). The listed sponsor is Linshom Medical, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Respiratory Complication appearing as the primary indexed condition, and to 1 intervention - of which Linshom Continuous Predictive Respiratory Monitoring is the first listed.
NCT06744790 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06744790 about?
NCT06744790 is a clinical study titled "Advanced Prediction of Respiratory Depression Episode Using the Linshom Continuous Predictive Respiratory Sensor". 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 serio...
What is the current status of trial NCT06744790?
This trial is currently recruiting. The enrollment target is 320 participants. The study started on 2023-06-21. Estimated completion is 2025-06-16.
What conditions does trial NCT06744790 study?
This clinical trial studies the following conditions: Respiratory Complication, Post Surgical Respiratory Failure.
What interventions are being tested in trial NCT06744790?
The interventions under investigation include: Linshom Continuous Predictive Respiratory Monitoring (DEVICE).
Who is sponsoring clinical trial NCT06744790?
This trial is sponsored by Linshom Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06744790 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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