Patients Prescribed Non-invasive Respiratory MonitoringRespRateNCT03593603
Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
An observational study of Patients Prescribed Non-invasive Respiratory Monitoring, run by Medtronic - MITG at 2 sites in United States.
Trial summary
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the clinical space on the function of the Nellcor™… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Prescribed Non-invasive Respiratory Monitoring
- What is being tested?
- Nellcor™ Bedside Respiratory Monitoring System
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2018to 3 May 2019
- 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: Patients will be included who provide informed consent, who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. Potential subjects are those who will be admitted to the General Care Floor. The subject pool will be approximately divided equally between medical/non-surgical and surgical patients.
Who may be able to join
- 18 years or older.
- A patient who meets the weight requirement for the sensor (e.g. >30kg).
- A patient at the study site on a General Care Floor (surgical or medical/non-surgical to be distributed equally) and prescribed standard vital sign checks.
- Patient is willing and able to provide written informed consent.
Who cannot join
- Expected length of stay is < 4 hours.
- Patient is pregnant or lactating.
- Patient has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- Patient has an abnormality that may prevent proper application of the device.
- Patient is in atrial fibrillation.
- Patient has a documented history of frequent premature atrial contractions (PACs) or premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds within the past 3 months.
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- Patient has an implanted pacemaker.
- Patient has excessive nail polish that cannot be removed or other dye or discoloration of the finger.
- Patient has diagnosed central apnea or diagnosed significant obstructive sleep apnea.
- Patient is currently using continuous positive airway pressure (CPAP).
- Patient is unwilling or unable to sign informed consent.
- Evidence that the patient cannot understand the purpose and risks of the study and would require a legally authorized representative to sign informed consent.
- Patient is participating in another potentially confounding clinical study.
- Extreme motion conditions such as patient is prescribed to walk more than once per hour or is prescribed a medical device resulting in constant movement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MultiCare Institute for Research & Innovation
Tacoma, Washington, 98405
St. John Health System
Tulsa, Oklahoma, 74104
About this study
Official title: An Evaluation of Plethysmography-based Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the clinical space on the function of the Nellcor™ Respiration Rate parameter. The primary objective is to describe spot check (e.g. manual observation) of respiration rate versus cumulative automated counting (trend) of respiratory rate as measured using the Nellcor™ Bedside Respiratory Patient Monitoring System with the Nellcor™ Respiration Rate parameter.
- Being tested
- Nellcor™ Bedside Respiratory Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellcor™ Bedside Respiratory Monitoring SystemDevice
Nellcor™ Bedside Respiratory Patient Monitoring System with Nellcor™ Respiration Rate Software and the Nellcor™ Adult Respiratory Sensor to provide continuous respiration rate monitoring
| Study group | Role | What they receive |
|---|---|---|
| Nellcor™ Bedside Respiratory Monitoring System | Patients on the general care floor who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours Receives: Device: Nellcor™ Bedside Respiratory Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of RR measured by spot checks vs continuous monitoring
Bias and a range of agreement of the differences between RR measured by spot checks and RR measured using the Nellcor™ Bedside Respiratory Patient Monitoring System
Measured: at least 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start11 Jul 2018
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Prescribed Non-invasive Respiratory MonitoringStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul J Amoroso, MD, Principal investigator, MultiCare Institute for Research and Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593603
- Sponsor's protocol ID
- MDT17002NELLRR
- Acronym
- RespRate
- Status last verified
- May 2019
- First submitted
- 10 Jul 2018
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Plethysmography-based Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
- ClinicalTrials.gov ID
- NCT03593603
- Acronym / sponsor ID
- RespRate / MDT17002NELLRR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 20 Jul 2018 (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.
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is intended to gain further information in the clinical space on the function of the Nellcor™ Respiration Rate parameter. The primary objective is to describe spot check (e.g. manual observation) of respiration rate versus cumulative automated counting (trend) of respiratory rate as measured using the Nellcor™ Bedside Respiratory Patient Monitoring System with the Nellcor™ Respiration Rate parameter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nellcor™ Bedside Respiratory Monitoring System | – | Device: Nellcor™ Bedside Respiratory Monitoring SystemPatients on the general care floor who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included who provide informed consent, who are prescribed non-invasive respiratory monitoring via spot check vital signs at least every 4 hours and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. Potential subjects are those who will be admitted to the General Care Floor. The subject pool will be approximately divided equally between medical/non-surgical and surgical patients.
Key inclusion criteria (4 listed)
- 18 years or older.
- A patient who meets the weight requirement for the sensor (e.g. >30kg).
- A patient at the study site on a General Care Floor (surgical or medical/non-surgical to be distributed equally) and prescribed standard vital sign checks.
- Patient is willing and able to provide written informed consent.
Key exclusion criteria (14 listed)
- Expected length of stay is < 4 hours.
- Patient is pregnant or lactating.
- Patient has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
- Patient has an abnormality that may prevent proper application of the device.
- Patient is in atrial fibrillation.
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 |
|---|---|---|
| Nellcor™ Bedside Respiratory Monitoring SystemNellcor™ Bedside Respiratory Patient Monitoring System with Nellcor™ Respiration Rate Software and the Nellcor™ Adult Respiratory Sensor to provide continuous respiration rate monitoring | Device | Nellcor™ Bedside Respiratory Monitoring System |
Primary outcome
Agreement of RR measured by spot checks vs continuous monitoring
Time frame: at least 4 hours
Bias and a range of agreement of the differences between RR measured by spot checks and RR measured using the Nellcor™ Bedside Respiratory Patient Monitoring System
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 23 May 2019.
- Individual participant dataSharing planned: No
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.
Paul J Amoroso, MD principal investigator
MultiCare Institute for Research and Innovation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Prescribed Non-invasive Respiratory Monitoring, run by Medtronic - MITG at 2 sites 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 4 inclusion and 14 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 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Agreement of RR measured by spot checks vs continuous monitoring (time frame: at least 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2019.