Focus of the Study is Measuring Respiratory RateNCT01881269
Respiration Rate Monitoring During Transitions
An observational study of Focus of the Study is Measuring Respiratory Rate, run by Medtronic - MITG at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Measuring Respiratory Rate
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Sep 2013
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer subjects from a hospital population, who are scheduled to undergo surgery requiring general anesthesia
Who may be able to join
- Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
- American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
- Body mass index (BMI) ≤30 kg/m2.
- Subject is willing and able to provide written consent.
Who cannot join
- Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
- Female subjects who are currently lactating and breastfeeding.
- Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
- Subject has an abnormality that may prevent proper application of the device/sensors.
- 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.
Show all 9Show fewer
- Subject has an implanted pacemaker.
- Subjects with non-sinus rhythm, frequent premature ventricular complexes (> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG.
- Subjects with artificial finger nails.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.
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 |
|---|---|---|
| No treatment | No treatment, prospective observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to report a Respiration Rate value after initiation of controlled ventilation
Time (in seconds) for the software to report a Respiration Rate value within one breath per minute of the controlled ventilation rate after placement of the airway device (endotracheal tube or laryngeal mask airway)
Measured: 1 - 3 minutes after the initiation of controlled ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is Measuring 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joshua Lumbley, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881269
- Sponsor's protocol ID
- COVMOPR0409
- Status last verified
- Nov 2013
- First submitted
- 17 Jun 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation
- ClinicalTrials.gov ID
- NCT01881269
- Acronym / sponsor ID
- COVMOPR0409
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Jun 2013 (estimated)
- 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.
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.
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 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer subjects from a hospital population, who are scheduled to undergo surgery requiring general anesthesia
Key inclusion criteria (4 listed)
- Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia.
- American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3.
- Body mass index (BMI) ≤30 kg/m2.
- Subject is willing and able to provide written consent.
Key exclusion criteria (9 listed)
- Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records.
- Female subjects who are currently lactating and breastfeeding.
- Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation.
- Subject has an abnormality that may prevent proper application of the device/sensors.
- Subject 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.
Primary outcome
Time to report a Respiration Rate value after initiation of controlled ventilation
Time frame: 1 - 3 minutes after the initiation of controlled ventilation
Time (in seconds) for the software to report a Respiration Rate value within one breath per minute of the controlled ventilation rate after placement of the airway device (endotracheal tube or laryngeal mask airway)
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 6 Nov 2013.
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 Focus of the Study is Measuring 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 9 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 6 Nov 2013. 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?
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?
Time to report a Respiration Rate value after initiation of controlled ventilation (time frame: 1 - 3 minutes after the initiation of controlled ventilation). 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 6 Nov 2013.