Occult BleedingNCT04912232
Trauma Study: Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
A study testing Detection of Occult Hemorrhage in Trauma Patients in people with Occult Bleeding and Hemorrhage, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occult Bleeding, Hemorrhage
- What is being tested?
- Detection of Occult Hemorrhage in Trauma Patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 8 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Awake and alert GCS >14
- Admission systolic blood pressure greater than 90 and heart rate less than 120
- Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Who cannot join
- Altered mental status GCS < 13
- Systolic blood pressure less than 90 or heart rate greater than 120
- Need for ongoing fluid or pressor support (standard local fluid resuscitation only)
- Clinically significant ongoing external hemorrhage
- Respiratory distress with O2 saturation <96%
- Pre-existing systemic illness, likely to alter systemic cardiovascular response to hemorrhage (overt clinical heart failure). Including congestive heart failure, and a paced cardiac rhythm.
- Pregnant
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Continued Development of a Multiplex Precision Medicine System for Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage.
Early detection of ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH with an acceptable rate of false-positives and false-negatives would save countless lives. Additionally, such technology would save significant time, money and effort by allowing medical resources to be applied more accurately - the essence of precision medicine. An automated system would monitor currently stable patients continuously, leaving clinicians free to care for patients in need of attention.
Read the detailed description
The investigators will enroll 480 trauma patients in a "no significant risk" prospective clinical trial to 1) evaluate the performance of a Mark I prototype, 2) validate the performance of the Phase II algorithm, and 3) re-train the algorithm to Phase III iteration.
This is not a therapeutic study. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.
As a minimal risk study, there will be no change from standard of care for patients undergoing surgery. The surgical procedures and pharmacotherapies will proceed as per standard clinical management.
Enrolled patients will undergo standard preoperative, anesthetic, and postoperative physiological monitoring that includes:
Electrocardiogram: Heart rate and electrical activity of the heart will be recorded via a 3-lead ECG.
Arterial Oxygen Saturation (SpO2): Pulse oximetry will be recorded using a commercially available finger pulse oximeter.
Finger Photoplethysmography: waveforms will be obtained non-invasively from either the SpO2 photoplethysmography or alternatively a Flashback Technologies Compensatory Reserve Index (CRI™) device.
In addition to these standard physiologic measurements, as a part of the research, the investigators will also acquire the following non-invasive optical and impedance measurements. All of these devices have been previously validated as non-invasive and safe in humans. The impedance electrodes and optical emitter/detectors will be incorporated into easily applied latex-free based "belts" that will be applied to anatomic locations along the thorax, abdomen and thigh. Application of these belts will be as soon as practical after patient arrival.
The clinicians providing care to the patient will be blind with respect to the measurements from these devices.
Continuous-wave Near-Infrared Spectroscopy (CW-NIRS) Device, custom built:
The device is built on an Ocean Optics FLAME USB Spectrometers, with two OSRAM 4736 NIR LEDs in plastic holders meant to be taped or strapped to the patient on the chest/torso and thigh locations. An Oceans Optics tungsten-halogen light source is used for an additional probe location on the forehead. Probe holders are designed to collect light from surface of skin by means of a mirror and collimator. The device will collect data on light attenuation of muscle in models of shock/trauma. The light output for all locations is below the ANSI limits for maximum permissible skin exposure.
SwissTom Electrical Impedance Tomography (EIT) System:
Name of device: Pioneer Set (Electrical Impedance Tomography System) Device Manufacturer: SwissTom AG (Parent company SenTec AG)
This device monitors dynamically changing perfusion physiology. To record multiplexed impedance signature a belt of 16-32 electrodes is placed around the thorax above the nipple line and thigh and impedances are recorded between multiple sets of electrodes.
SwissTom develops a clinical EIT system that is approved for pulmonary imaging. This Pioneer system is their research platform that has similar functionality and safety performance to their clinical system but provides research teams with access to raw data and additional functionality for specifying imaging parameters (e.g. control of frame rates, signal frequency acquisition, electrode drive patterns).
ScioSpec MultiChannel Electrical Impedance Spectroscopy (EIS) System:
Name of device: ISX-Mini (MultiChannel Electrical Impedance Spectroscopy System) Device Manufacturer: ScioSpec
To record multiplexed impedance signatures- an array of 4 electrodes is placed around the cranium and thorax of the patient and impedance spectroscopy signatures are recorded at each anatomic location. This device monitors dynamically changing intracranial, intrathoracic and intra-abdominal physiology.
General Approach to Minimize Risk:
This protocol will be minimal risk to patients as there is little risk associated with the placement of these devices and they can be removed at any time. They don't interfere with standard equipment used in clinical management of trauma patients.
- Conditions
- Occult Bleeding, Hemorrhage
- Being tested
- Detection of Occult Hemorrhage in Trauma Patients
- Keywords
- Occult Bleeding, Hemorrhage, Hemorrhagic Shock, Trauma Injury, Precision Medicine, Triage, Bioimpedance, Electrical Impedance Tomography, Electrical Impedance Spectroscopy, Near-Infrared Spectroscopy
- Medical subject headings
- Hemorrhage, Shock, Hemorrhagic, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Occult Hemorrhage in Trauma PatientsDevice
Non-invasive monitoring of trauma patients
| Study group | Role | What they receive |
|---|---|---|
| Trauma Patients | Experimental | Patients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage:
1. Awake and alert GCS >14
2. Admission systolic blood pressure greater than 90 and heart rate less than 120
3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission) Receives: Device: Detection of Occult Hemorrhage in Trauma Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm Performance: Time of Alarm Before Onset of Deterioration
Measured: patient data will be collected over 3-6 hours
Algorithm Performance: Sensitivity as Measured by for Alarm/no Alarm Outcome
Measured: patient data will be collected over 3-6 hours
Algorithm Performance: Specificity as Measured by for Alarm/no Alarm Outcome
Measured: patient data will be collected over 3-6 hours
Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome
Measured: patient data will be collected over 3-6 hours
Algorithm Performance: Negative Predictive Value for Alarm/no Alarm Outcome
Measured: patient data will be collected over 3-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start8 Dec 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Why it stopped: Grant funding for the study ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Occult BleedingStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Dartmouth College, Baystate Medical Center
- Responsible party
- Sponsor
- Investigators
- Noman Paradis, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912232
- Sponsor's protocol ID
- STUDY02001495
- Status last verified
- Jun 2023
- First submitted
- 28 May 2021
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: At this time, there are no plans to share IPD.
Publications
Shackelford SA, Colton K, Stansbury LG, Galvagno SM Jr, Anazodo AN, DuBose JJ, Hess JR, Mackenzie CF. Early identification of uncontrolled hemorrhage after trauma: current status and future direction. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S222-7. doi: 10.1097/TA.0000000000000198. No abstract available.
PubMed 24770559Parks JK, Elliott AC, Gentilello LM, Shafi S. Systemic hypotension is a late marker of shock after trauma: a validation study of Advanced Trauma Life Support principles in a large national sample. Am J Surg. 2006 Dec;192(6):727-31. doi: 10.1016/j.amjsurg.2006.08.034.
PubMed 17161083Wo CC, Shoemaker WC, Appel PL, Bishop MH, Kram HB, Hardin E. Unreliability of blood pressure and heart rate to evaluate cardiac output in emergency resuscitation and critical illness. Crit Care Med. 1993 Feb;21(2):218-23. doi: 10.1097/00003246-199302000-00012.
PubMed 8428472Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.
PubMed 21795890Convertino VA. Blood pressure measurement for accurate assessment of patient status in emergency medical settings. Aviat Space Environ Med. 2012 Jun;83(6):614-9. doi: 10.3357/asem.3204.2012.
PubMed 22764618Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.
PubMed 24637618Soller BR, Yang Y, Soyemi OO, Ryan KL, Rickards CA, Walz JM, Heard SO, Convertino VA. Noninvasively determined muscle oxygen saturation is an early indicator of central hypovolemia in humans. J Appl Physiol (1985). 2008 Feb;104(2):475-81. doi: 10.1152/japplphysiol.00600.2007. Epub 2007 Nov 15.
PubMed 18006869Belle A, Ansari S, Spadafore M, Convertino VA, Ward KR, Derksen H, Najarian K. A Signal Processing Approach for Detection of Hemodynamic Instability before Decompensation. PLoS One. 2016 Feb 12;11(2):e0148544. doi: 10.1371/journal.pone.0148544. eCollection 2016.
PubMed 26871715
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continued Development of a Multiplex Precision Medicine System for Early Warning of Progression Toward Hemodynamic Deterioration After Trauma
- ClinicalTrials.gov ID
- NCT04912232
- Acronym / sponsor ID
- STUDY02001495
- Conditions
- Occult Bleeding, Hemorrhage
- Keywords
- Occult Bleeding, Hemorrhage, Hemorrhagic Shock, Trauma Injury, Precision Medicine, Triage, Bioimpedance, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant funding for the study ended.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense, Dartmouth College, Baystate Medical Center
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is Phase 3 of a three-phase DOD CDMRP funded project for the development of a multi-technology poly-anatomic noninvasive system for early detection of occult hemorrhage.
Early detection of ongoing hemorrhage (OH) before onset of shock is a universally acknowledged great unmet need, and particularly important after trauma. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH with an acceptable rate of false-positives and false-negatives would save countless lives. Additionally, such technology would save significant time, money and effort by allowing medical resources to be applied more accurately - the essence of precision medicine. An automated system would monitor currently stable patients continuously, leaving clinicians free to care for patients in need of attention.
Detailed description
The investigators will enroll 480 trauma patients in a "no significant risk" prospective clinical trial to 1) evaluate the performance of a Mark I prototype, 2) validate the performance of the Phase II algorithm, and 3) re-train the algorithm to Phase III iteration.
This is not a therapeutic study. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.
As a minimal risk study, there will be no change from standard of care for patients undergoing surgery. The surgical procedures and pharmacotherapies will proceed as per standard clinical management.
Enrolled patients will undergo standard preoperative, anesthetic, and postoperative physiological monitoring that includes:
Electrocardiogram: Heart rate and electrical activity of the heart will be recorded via a 3-lead ECG.
Arterial Oxygen Saturation (SpO2): Pulse oximetry will be recorded using a commercially available finger pulse oximeter.
Finger Photoplethysmography: waveforms will be obtained non-invasively from either the SpO2 photoplethysmography or alternatively a Flashback Technologies Compensatory Reserve Index (CRI™) device.
In addition to these standard physiologic measurements, as a part of the research, the investigators will also acquire the following non-invasive optical and impedance measurements. All of these devices have been previously validated as non-invasive and safe in humans. The impedance electrodes and optical emitter/detectors will be incorporated into easily applied latex-free based "belts" that will be applied to anatomic locations along the thorax, abdomen and thigh. Application of these belts will be as soon as practical after patient arrival.
The clinicians providing care to the patient will be blind with respect to the measurements from these devices.
Continuous-wave Near-Infrared Spectroscopy (CW-NIRS) Device, custom built:
The device is built on an Ocean Optics FLAME USB Spectrometers, with two OSRAM 4736 NIR LEDs in plastic holders meant to be taped or strapped to the patient on the chest/torso and thigh locations. An Oceans Optics tungsten-halogen light source is used for an additional probe location on the forehead. Probe holders are designed to collect light from surface of skin by means of a mirror and collimator. The device will collect data on light attenuation of muscle in models of shock/trauma. The light output for all locations is below the ANSI limits for maximum permissible skin exposure.
SwissTom Electrical Impedance Tomography (EIT) System:
Name of device: Pioneer Set (Electrical Impedance Tomography System) Device Manufacturer: SwissTom AG (Parent company SenTec AG)
This device monitors dynamically changing perfusion physiology. To record multiplexed impedance signature a belt of 16-32 electrodes is placed around the thorax above the nipple line and thigh and impedances are recorded between multiple sets of electrodes.
SwissTom develops a clinical EIT system that is approved for pulmonary imaging. This Pioneer system is their research platform that has similar functionality and safety performance to their clinical system but provides research teams with access to raw data and additional functionality for specifying imaging parameters (e.g. control of frame rates, signal frequency acquisition, electrode drive patterns).
ScioSpec MultiChannel Electrical Impedance Spectroscopy (EIS) System:
Name of device: ISX-Mini (MultiChannel Electrical Impedance Spectroscopy System) Device Manufacturer: ScioSpec
To record multiplexed impedance signatures- an array of 4 electrodes is placed around the cranium and thorax of the patient and impedance spectroscopy signatures are recorded at each anatomic location. This device monitors dynamically changing intracranial, intrathoracic and intra-abdominal physiology.
General Approach to Minimize Risk:
This protocol will be minimal risk to patients as there is little risk associated with the placement of these devices and they can be removed at any time. They don't interfere with standard equipment used in clinical management of trauma patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma Patients | Experimental | Device: Detection of Occult Hemorrhage in Trauma PatientsPatients suffering blunt and/or penetrating trauma but without physiologic criteria suggestive of ongoing hemorrhage: 1. Awake and alert GCS >14 2. Admission systolic blood pressure greater than 90 and heart rate less than 120 3. Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Awake and alert GCS >14
- Admission systolic blood pressure greater than 90 and heart rate less than 120
- Without signs of clinically significant ongoing external hemorrhage with no active bleeding documented on radiology/ultrasound and stable vital signs (no signs of hemodynamic deterioration) during initial evaluation (approximately 15 minutes post admission)
Key exclusion criteria (8 listed)
- Altered mental status GCS < 13
- Systolic blood pressure less than 90 or heart rate greater than 120
- Need for ongoing fluid or pressor support (standard local fluid resuscitation only)
- Clinically significant ongoing external hemorrhage
- Respiratory distress with O2 saturation <96%
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 |
|---|---|---|
| Detection of Occult Hemorrhage in Trauma PatientsNon-invasive monitoring of trauma patients | Device | Trauma Patients |
Primary outcome
Algorithm Performance: Time of Alarm Before Onset of Deterioration
Time frame: patient data will be collected over 3-6 hours
Algorithm Performance: Sensitivity as Measured by for Alarm/no Alarm Outcome
Time frame: patient data will be collected over 3-6 hours
Algorithm Performance: Specificity as Measured by for Alarm/no Alarm Outcome
Time frame: patient data will be collected over 3-6 hours
Algorithm Performance: Positive Predictive Value for Alarm/no Alarm Outcome
Time frame: patient data will be collected over 3-6 hours
Algorithm Performance: Negative Predictive Value for Alarm/no Alarm Outcome
Time frame: patient data will be collected over 3-6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24770559Shackelford SA, Colton K, Stansbury LG, Galvagno SM Jr, Anazodo AN, DuBose JJ, Hess JR, Mackenzie CF. Early identification of uncontrolled hemorrhage after trauma: current status and future direction. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S222-7. doi: 10.1097/TA.0000000000000198. No abstract available.
- Background: PubMed 17161083Parks JK, Elliott AC, Gentilello LM, Shafi S. Systemic hypotension is a late marker of shock after trauma: a validation study of Advanced Trauma Life Support principles in a large national sample. Am J Surg. 2006 Dec;192(6):727-31. doi: 10.1016/j.amjsurg.2006.08.034.
- Background: PubMed 8428472Wo CC, Shoemaker WC, Appel PL, Bishop MH, Kram HB, Hardin E. Unreliability of blood pressure and heart rate to evaluate cardiac output in emergency resuscitation and critical illness. Crit Care Med. 1993 Feb;21(2):218-23. doi: 10.1097/00003246-199302000-00012.
- Background: PubMed 21795890Convertino VA, Moulton SL, Grudic GZ, Rickards CA, Hinojosa-Laborde C, Gerhardt RT, Blackbourne LH, Ryan KL. Use of advanced machine-learning techniques for noninvasive monitoring of hemorrhage. J Trauma. 2011 Jul;71(1 Suppl):S25-32. doi: 10.1097/TA.0b013e3182211601.
- Background: PubMed 22764618Convertino VA. Blood pressure measurement for accurate assessment of patient status in emergency medical settings. Aviat Space Environ Med. 2012 Jun;83(6):614-9. doi: 10.3357/asem.3204.2012.
- Background: PubMed 24637618Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.
- Background: PubMed 18006869Soller BR, Yang Y, Soyemi OO, Ryan KL, Rickards CA, Walz JM, Heard SO, Convertino VA. Noninvasively determined muscle oxygen saturation is an early indicator of central hypovolemia in humans. J Appl Physiol (1985). 2008 Feb;104(2):475-81. doi: 10.1152/japplphysiol.00600.2007. Epub 2007 Nov 15.
- Background: PubMed 26871715Belle A, Ansari S, Spadafore M, Convertino VA, Ward KR, Derksen H, Najarian K. A Signal Processing Approach for Detection of Hemodynamic Instability before Decompensation. PLoS One. 2016 Feb 12;11(2):e0148544. doi: 10.1371/journal.pone.0148544. eCollection 2016.
- Individual participant dataSharing planned: No. At this time, there are no plans to share IPD.
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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.
Noman Paradis, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of Occult Hemorrhage in Trauma Patients in people with Occult Bleeding and Hemorrhage, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 May 2024. 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?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Algorithm Performance: Time of Alarm Before Onset of Deterioration (time frame: patient data will be collected over 3-6 hours). The study lists 5 primary outcomes in all. 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 NCT04912232, which also lists 8 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 24 May 2024.