Respiratory RateNCT01837537

Respiration Rate V2.0 in a Hospital Setting

An observational study of Respiratory Rate, run by Medtronic - MITG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device) in a hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Respiratory Rate
How many people: 90 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Oct 2013
Phase: Observational
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

Study population: Volunteer subjects from a hospital setting on the general care floor or general surgical care floor

Who may be able to join

Male or female.
18 years or older.
A patient at the study site on a General Care Floor or General Surgery Care Floor.
Subject is willing and able to provide written consent.

Who cannot join

Subject is younger than 18.
Subject 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.
Subject has an abnormality that may prevent proper application of the device.
Subject is in atrial fibrillation.
Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.
Subject has an implanted pacemaker.
Subject is unwilling or unable to sign informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Read the detailed description

Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients.

The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Conditions: Respiratory Rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01837537
Study group	Role	What they receive
no treatment		no treatment, prospective observational

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).
Measured: up to 40 minutes of continuous monitoring

Secondary outcomes (1)

Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor
The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.
Measured: up to 40 minutes of continuous monitoring

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Oct 2013

First posted23 Apr 2013 (estimated)
Study startMar 2013
Primary completionAug 2013
Study completionOct 2013

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.
Other trials for Respiratory RateStudies 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: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01837537
Sponsor's protocol ID: COVMOPR0399
Status last verified: Jun 2017
First submitted: 17 Apr 2013
Last updated: 17 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
ClinicalTrials.gov ID: NCT01837537
Acronym / sponsor ID: COVMOPR0399
Conditions: Respiratory Rate
Study type: Observational
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Aug 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 23 Apr 2013 (estimated)
Results: Posted 3 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
no treatment	–	–no treatment, prospective observational

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Volunteer subjects from a hospital setting on the general care floor or general surgical care floor

Key inclusion criteria (4 listed)

Male or female.
18 years or older.
A patient at the study site on a General Care Floor or General Surgery Care Floor.
Subject is willing and able to provide written consent.

Key exclusion criteria (7 listed)

Subject is younger than 18.
Subject 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.
Subject has an abnormality that may prevent proper application of the device.
Subject is in atrial fibrillation.
Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Time frame: up to 40 minutes of continuous monitoring
The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).

1 secondary outcome

Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor
Time frame: up to 40 minutes of continuous monitoring

Results and safety

Results posted to the registry on 3 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
no Treatment	90	90

Primary outcome: Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor

Time frame: up to 40 minutes of continuous monitoring. Mean (Standard Deviation). Unit: BrPM (breaths per minute)

Measure	no Treatment n = 75
Value	-0.82 (2.19)

Population analysed: 90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
no Treatment	0 of 90 (0%)	0 of 90 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Rate

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome

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.

Joshua Lumbley, MD principal investigator

Ohio State University

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 Respiratory Rate, run by Medtronic - MITG 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 4 inclusion and 7 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 17 Jul 2017. 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 3 Feb 2017). 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?

Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor (time frame: up to 40 minutes of continuous monitoring). 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 NCT01837537.

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 17 Jul 2017.