Respiratory InsufficiencyNCT01306201
Novel Non-Invasive Monitoring Parameter in a Hospital Setting
An observational study of Respiratory Insufficiency and Respiratory Failure, run by Medtronic - MITG at 2 sites in United States.
Trial summary
Data collected from this study will be used to evaluate the performance of a monitoring algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Failure
- How many people
- 63 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Mar 2012
- 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: General Care Floor Patients
Who may be able to join
- Subjects 18 years old or older
- Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- Subjects on general care floor
Who cannot join
- Severe contact allergies to standard adhesive materials
- Abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant arrhythmia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center (OSUMC)
Columbus, Ohio, 43210
The University of Colorado Health Sciences Center (UCHSC)
Denver, Colorado, 80262
About this study
Official title: A Novel Cardio-Respiratory Parameter in a Hospital Setting
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
Read the detailed description
The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- Hospital Setting
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In-patient Volunteers | In-patients from the hospital who choose to participate in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.
Measured: Participants were monitored for average of 30 minutes
Secondary outcomes (1)
The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
The data used for analysis consisted of multiple simultaneous measures of RR_TTI, RR_V1.0 and RR_EtCO2 for each subject. Given N sets of simultaneous RR values for each of P patients, the simultaneous RR values were used to calculate a pair of RMSD values for each subject.
The two RMSD values, RMSDRR_V1.0_vs_EtCO2, and RMSDTTI_vs_EtCO2, quantify the mean absolute difference in simultaneous estimates of respiratory rate between RR_V1.0 compared with RR_EtCO2 and RR_TTI compared with RR_EtCO2, respectively for the subjects with 95% confidence of mean ± 3.38 BrPM. The Measure type is Number and represents the RMSD of Covidien Nellcor Respiration Rate Software
Measured: Participants were monitored on average for 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2012
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 InsufficiencyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sergio Bergese, MD, Principal investigator, The Ohio State Medical Center, Dept of AnesthesiaRobert McIntyre, MD, Principal investigator, University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306201
- Sponsor's protocol ID
- COVMOPR0131
- Status last verified
- Aug 2014
- First submitted
- 10 Feb 2011
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Cardio-Respiratory Parameter in a Hospital Setting
- ClinicalTrials.gov ID
- NCT01306201
- Acronym / sponsor ID
- COVMOPR0131
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- Hospital Setting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Posted 10 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Data collected from this study will be used to evaluate the performance of a monitoring algorithm.
Detailed description
The goal of this study is to assess equivalency, performance, and accuracy of a new monitoring algorithm in a hospital setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-patient Volunteers | – | –In-patients from the hospital who choose to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General Care Floor Patients
Key inclusion criteria (3 listed)
- Subjects 18 years old or older
- Written informed consent from the patient or their legally authorized representative before initiation of any study-related procedures
- Subjects on general care floor
Key exclusion criteria (4 listed)
- Severe contact allergies to standard adhesive materials
- Abnormalities that may prevent proper application of the device
- Women who are pregnant or lactating
- Subjects with significant arrhythmia
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
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device.
Time frame: Participants were monitored for average of 30 minutes
Mean and standard deviations of respiration rates collected from patients in the hospital settings were compared between Covidien Respiration Rate Software, Transthoracic Impedance and End-Tidal Carbon Dioxide Waveforms. Each patient served as its own control.
1 secondary outcome
The Covidien Nellcor Respiration Rate Software Shall Calculate Respiration Rate With a Root Mean Square Difference (RMSD) of < 3 Breaths Per Minute Compared With a End-Tidal Carbon Dioxide Waveforms, With 95% Confidence.
Time frame: Participants were monitored on average for 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sergio Bergese, MD principal investigator
The Ohio State Medical Center, Dept of Anesthesia
Robert McIntyre, MD principal investigator
University of Colorado Denver, School of Medicine dept of Surgery Division of GI, Tumor and Endocrine Surgery
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 Respiratory Insufficiency and Respiratory Failure, 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 3 inclusion and 4 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 7 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2013). 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?
The Covidien Nellcor Respiration Rate Software Shall Determine Respiration Rate Measured as Mean and Standard Deviation With Accuracy That is Non-inferior to Predicate Device. (time frame: Participants were monitored for average of 30 minutes). 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 7 Aug 2014.