HypoxiaNCT04005911
Non-Contact Respiratory Rate Monitoring
An observational study of Hypoxia, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxia
- What is being tested?
- Themography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to Sep 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
- Adult, Older adult
Study population: Post-surgical patients in the PACU at the University of Virginia
Who may be able to join
- Underwent surgery at the University of Virginia
- Able to provide verbal consent to participate in the study
Who cannot join
- Unable to provide verbal consent to participate in the study
- Youth
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Robert H Thiele, MD, 434-924-2283, rht7w@virginia.edu
About this study
Official title: Evaluation of Non-Contact Respiratory Rate Monitor in Post-Surgical Subjects
The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.
- Conditions
- Hypoxia
- Being tested
- Themography
- Keywords
- Post-surgical
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThemographyDevice
Using a FLIR camera, a thermographic recording will be taken of the patient while breathing. Simultaneously, the research investigator will record the thoracic impedance-based respiratory rate as well as manually count respirations in one minute.
| Study group | Role | What they receive |
|---|---|---|
| Post-Surgical | Patients who underwent surgery and were admitted to the PACU Receives: Device: Themography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between manually calculated respiratory rate and thermographic respiratory rate
Agreement between manually calculated respiratory rate and thermographic respiratory rate using the Limits of Agreement approach
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start18 Apr 2019
- Primary completionJul 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Thiele, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005911
- Sponsor's protocol ID
- 21353
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Contact Respiratory Rate Monitor in Post-Surgical Subjects
- ClinicalTrials.gov ID
- NCT04005911
- Acronym / sponsor ID
- 21353
- Conditions
- Hypoxia
- Keywords
- Post-surgical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 2 Jul 2019 (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.
The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Surgical | – | Device: ThemographyPatients who underwent surgery and were admitted to the PACU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post-surgical patients in the PACU at the University of Virginia
Key inclusion criteria (2 listed)
- Underwent surgery at the University of Virginia
- Able to provide verbal consent to participate in the study
Key exclusion criteria (3 listed)
- Unable to provide verbal consent to participate in the study
- Youth
- Prisoners
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 |
|---|---|---|
| ThemographyUsing a FLIR camera, a thermographic recording will be taken of the patient while breathing. Simultaneously, the research investigator will record the thoracic impedance-based respiratory rate as well as manually count respirations in one minute. | Device | Post-Surgical |
Primary outcome
Agreement between manually calculated respiratory rate and thermographic respiratory rate
Time frame: 5 minutes
Agreement between manually calculated respiratory rate and thermographic respiratory rate using the Limits of Agreement approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hypoxia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Enrolling by invitation
Extubation Safety Via Microstream EtCO₂ (IPI) Monitoring
Hypoxemia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
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.
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 Hypoxia, run by University of Virginia 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Thiele, M.D. (434-243-9412, rht7w@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between manually calculated respiratory rate and thermographic respiratory rate (time frame: 5 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 18 Jul 2019.