TachypneaNCT02837341
Camera-based Measurement of Respiratory Rates
A study testing Philips®Vital Sign Device - Camera-based system (Prototype) in people with Tachypnea, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Respiratory rate as an important predictor for adverse events, but still a neglected vital sign. Precise and simple measurement of the respiratory rate in volunteers by a new electronic camera device in different settings. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tachypnea
- What is being tested?
- Philips®Vital Sign Device - Camera-based system (Prototype)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older
- healthy male volunteers
- BMI 19-25
Who cannot join
- pulmonary diseases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Intensive Care Unit, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Respiratory rate as an important predictor for adverse events, but still a neglected vital sign.
Precise and simple measurement of the respiratory rate in volunteers by a new electronic camera device in different settings.
Read the detailed description
Background of the study The respiratory rate (RR) is an important vital sign to be monitored in the emergency room, as it is a sensitive predictor of risk and critical illness . An increased RR is a sensitive and independent marker of increased mortality in patients with community acquired pneumonia and in unselected patients presenting to the emergency department (ED): This is why the RR is a component in many risk scores for prediction of adverse outcomes, such as the 'Confusion/Urea/Respiratory rate/Blood pressure/-Age 65 or older' (CURB-65) score, the Modified Early Warning Score (MEWS), Trauma Score, Revised Trauma Score, APACHE II (Acute Physiology and Chronic Health Evaluation) and PRISM (Paediatric Risk of Mortality ). Additionally, it is part of the Systemic Inflammatory Response Syndrome (SIRS) Sepsis-definition and definitions for weaning a patient from a ventilator (RSBI, Rapid Shallow Breathing Index, ). In some cases, measurement of the oxygen saturation is not sufficient as tachypnoea may not always have a connection to hypoxia . Hence, RR plays an important role in triage of patients presenting to the emergency room. Especially tachypnoea brings the need for more detailed monitoring and investigation. Tachypnea/Bradypnoea can be seen as a red flag and may indicate a big variety of diseases like heart failure, pneumonia, metabolic disturbances or pulmonary embolism. Recent studies could demonstrate that also trends of RR are reliable predictors of clinical outcome. Especially an increase in tachypnoea during hospitalisation is associated with high mortality A careful and exact measurement is essential. In emergency situations the RR is one component of the Emergency Severity Index (ESI) algorithm and a mandatory vital sign measured at decision point "D". However, its measurement is often omitted due to time constraints . Moreover documented pathologic RR in ER scenarios indicating hypoxia are often neglected leading to fatal events and contributing to deaths caused by medical errors.
According to recommendations of the World Health Organization (WHO) the RR should be measured by counting the breaths over a period of 1 minute by counting how many times the chest rises. This should be done when the patient is at rest. This appears impractical due to time consumption and workload for nursing staff in an emergency department. Studies have shown that this fact is a main reason why RR is often not recorded and critical situations might be missed. A prospective study by Lovett et al. demonstrated that the measurement of RR by nursing staff and even by impedance plethysmography as a common used device have a low sensitivity in detecting brady- or tachypnoea. The vital sign measurements may also differ according to observer variability. The approach to use mobile devices for RR measurement has shown encouraging results to improve efficiency in comparison to traditional methods though the field of using mobile devices is still in an experimental stadium.
The investigators aim to compare the results given by the camera-based measurements to the results given by capnography. The goal of the survey is to analyse the accuracy of measurements performed by the software.
The investigators will recruit healthy volunteers without any history of pulmonary diseases for an analysis of RR monitoring. Upon agreement the investigators will measure the RR camera-based by a device and simultaneously count the RR by capnography as a reference method. The data will be collected through a standardised protocol and archived in an Access(R) database. Different settings (e.g. supine vs sitting) will be assessed. Results will be depicted in a Bland-Altmann plot. In a first step the investigators plan to do a feasibility study, after that, as a second step, they will continue to measure the RR in different positions and situations to simulate a situation similar to emergency conditions.
- Conditions
- Tachypnea
- Being tested
- Philips®Vital Sign Device - Camera-based system (Prototype)
- Keywords
- medical device
- Medical subject headings
- Tachypnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips®Vital Sign Device - Camera-based system (Prototype)Device
Respiratory rates monitored via camera-based system and capnography simultaneously The "Philips Vital Sign Device" will record chest movements by camera. The program will use an algorithm to convert the chest movements into the respiratory rate
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Other | Monitoring of respiratory rates via camera-based System Monitoring of respiratory rate by Philips®Vital Sign Device - Camera-based system (Prototype) and capnography simultaneously. Receives: Device: Philips®Vital Sign Device - Camera-based system (Prototype) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference between respiratory rates at different breathing spectra measured via camera
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole).
The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
Measured: study day 1
Absolute difference between respiratory rates at different breathing spectra measured via capnography
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole).
The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
Measured: study day 1
Absolute difference between respiratory rates at different breathing spectra measured via WHO standard (counting breaths for one minute)
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole).
The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
Measured: study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TachypneaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christian Nickel, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837341
- Sponsor's protocol ID
- EKNZ 2015-306
- Status last verified
- Dec 2016
- First submitted
- 12 Nov 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hodgetts TJ, Kenward G, Vlachonikolis IG, Payne S, Castle N. The identification of risk factors for cardiac arrest and formulation of activation criteria to alert a medical emergency team. Resuscitation. 2002 Aug;54(2):125-31. doi: 10.1016/s0300-9572(02)00100-4.
PubMed 12161291Strauss R, Ewig S, Richter K, Konig T, Heller G, Bauer TT. The prognostic significance of respiratory rate in patients with pneumonia: a retrospective analysis of data from 705,928 hospitalized patients in Germany from 2010-2012. Dtsch Arztebl Int. 2014 Jul 21;111(29-30):503-8, i-v. doi: 10.3238/arztebl.2014.0503.
PubMed 25142073Pollack MM, Ruttimann UE, Getson PR. Pediatric risk of mortality (PRISM) score. Crit Care Med. 1988 Nov;16(11):1110-6. doi: 10.1097/00003246-198811000-00006.
PubMed 3048900Bone RC, Sprung CL, Sibbald WJ. Definitions for sepsis and organ failure. Crit Care Med. 1992 Jun;20(6):724-6. doi: 10.1097/00003246-199206000-00002. No abstract available.
PubMed 1597021Meade M, Guyatt G, Cook D, Griffith L, Sinuff T, Kergl C, Mancebo J, Esteban A, Epstein S. Predicting success in weaning from mechanical ventilation. Chest. 2001 Dec;120(6 Suppl):400S-24S. doi: 10.1378/chest.120.6_suppl.400s.
PubMed 11742961Mower WR, Sachs C, Nicklin EL, Safa P, Baraff LJ. A comparison of pulse oximetry and respiratory rate in patient screening. Respir Med. 1996 Nov;90(10):593-9. doi: 10.1016/s0954-6111(96)90017-7.
PubMed 8959116Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
PubMed 11588210Goldhill DR, White SA, Sumner A. Physiological values and procedures in the 24 h before ICU admission from the ward. Anaesthesia. 1999 Jun;54(6):529-34. doi: 10.1046/j.1365-2044.1999.00837.x.
PubMed 10403864Kellett J, Murray A, Woodworth S, Huang W. Trends in weighted vital signs and the clinical course of 44,531 acutely ill medical patients while in hospital. Acute Med. 2015;14(1):3-9.
PubMed 25745643Grossmann FF, Nickel CH, Christ M, Schneider K, Spirig R, Bingisser R. Transporting clinical tools to new settings: cultural adaptation and validation of the Emergency Severity Index in German. Ann Emerg Med. 2011 Mar;57(3):257-64. doi: 10.1016/j.annemergmed.2010.07.021. Epub 2010 Oct 16.
PubMed 20952097Venkatesh AK, Curley D, Chang Y, Liu SW. Communication of Vital Signs at Emergency Department Handoff: Opportunities for Improvement. Ann Emerg Med. 2015 Aug;66(2):125-30. doi: 10.1016/j.annemergmed.2015.02.025. Epub 2015 Mar 21.
PubMed 25805116Hogan J. Why don't nurses monitor the respiratory rates of patients? Br J Nurs. 2006 May 11-24;15(9):489-92. doi: 10.12968/bjon.2006.15.9.21087.
PubMed 16723921Lovett PB, Buchwald JM, Sturmann K, Bijur P. The vexatious vital: neither clinical measurements by nurses nor an electronic monitor provides accurate measurements of respiratory rate in triage. Ann Emerg Med. 2005 Jan;45(1):68-76. doi: 10.1016/j.annemergmed.2004.06.016.
PubMed 15635313Edmonds ZV, Mower WR, Lovato LM, Lomeli R. The reliability of vital sign measurements. Ann Emerg Med. 2002 Mar;39(3):233-7. doi: 10.1067/mem.2002.122017.
PubMed 11867974Karlen W, Gan H, Chiu M, Dunsmuir D, Zhou G, Dumont GA, Ansermino JM. Improving the accuracy and efficiency of respiratory rate measurements in children using mobile devices. PLoS One. 2014 Jun 11;9(6):e99266. doi: 10.1371/journal.pone.0099266. eCollection 2014.
PubMed 24919062
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camera-based Measurement of Respiratory Rates
- ClinicalTrials.gov ID
- NCT02837341
- Acronym / sponsor ID
- EKNZ 2015-306
- Conditions
- Tachypnea
- Keywords
- medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Jul 2016 (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.
Respiratory rate as an important predictor for adverse events, but still a neglected vital sign.
Precise and simple measurement of the respiratory rate in volunteers by a new electronic camera device in different settings.
Detailed description
Background of the study The respiratory rate (RR) is an important vital sign to be monitored in the emergency room, as it is a sensitive predictor of risk and critical illness . An increased RR is a sensitive and independent marker of increased mortality in patients with community acquired pneumonia and in unselected patients presenting to the emergency department (ED): This is why the RR is a component in many risk scores for prediction of adverse outcomes, such as the 'Confusion/Urea/Respiratory rate/Blood pressure/-Age 65 or older' (CURB-65) score, the Modified Early Warning Score (MEWS), Trauma Score, Revised Trauma Score, APACHE II (Acute Physiology and Chronic Health Evaluation) and PRISM (Paediatric Risk of Mortality ). Additionally, it is part of the Systemic Inflammatory Response Syndrome (SIRS) Sepsis-definition and definitions for weaning a patient from a ventilator (RSBI, Rapid Shallow Breathing Index, ). In some cases, measurement of the oxygen saturation is not sufficient as tachypnoea may not always have a connection to hypoxia . Hence, RR plays an important role in triage of patients presenting to the emergency room. Especially tachypnoea brings the need for more detailed monitoring and investigation. Tachypnea/Bradypnoea can be seen as a red flag and may indicate a big variety of diseases like heart failure, pneumonia, metabolic disturbances or pulmonary embolism. Recent studies could demonstrate that also trends of RR are reliable predictors of clinical outcome. Especially an increase in tachypnoea during hospitalisation is associated with high mortality A careful and exact measurement is essential. In emergency situations the RR is one component of the Emergency Severity Index (ESI) algorithm and a mandatory vital sign measured at decision point "D". However, its measurement is often omitted due to time constraints . Moreover documented pathologic RR in ER scenarios indicating hypoxia are often neglected leading to fatal events and contributing to deaths caused by medical errors.
According to recommendations of the World Health Organization (WHO) the RR should be measured by counting the breaths over a period of 1 minute by counting how many times the chest rises. This should be done when the patient is at rest. This appears impractical due to time consumption and workload for nursing staff in an emergency department. Studies have shown that this fact is a main reason why RR is often not recorded and critical situations might be missed. A prospective study by Lovett et al. demonstrated that the measurement of RR by nursing staff and even by impedance plethysmography as a common used device have a low sensitivity in detecting brady- or tachypnoea. The vital sign measurements may also differ according to observer variability. The approach to use mobile devices for RR measurement has shown encouraging results to improve efficiency in comparison to traditional methods though the field of using mobile devices is still in an experimental stadium.
The investigators aim to compare the results given by the camera-based measurements to the results given by capnography. The goal of the survey is to analyse the accuracy of measurements performed by the software.
The investigators will recruit healthy volunteers without any history of pulmonary diseases for an analysis of RR monitoring. Upon agreement the investigators will measure the RR camera-based by a device and simultaneously count the RR by capnography as a reference method. The data will be collected through a standardised protocol and archived in an Access(R) database. Different settings (e.g. supine vs sitting) will be assessed. Results will be depicted in a Bland-Altmann plot. In a first step the investigators plan to do a feasibility study, after that, as a second step, they will continue to measure the RR in different positions and situations to simulate a situation similar to emergency conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | Other | Device: Philips®Vital Sign Device - Camera-based system (Prototype)Monitoring of respiratory rates via camera-based System Monitoring of respiratory rate by Philips®Vital Sign Device - Camera-based system (Prototype) and capnography simultaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and older
- healthy male volunteers
- BMI 19-25
Key exclusion criteria (1 listed)
- pulmonary diseases
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 |
|---|---|---|
| Philips®Vital Sign Device - Camera-based system (Prototype)Respiratory rates monitored via camera-based system and capnography simultaneously The "Philips Vital Sign Device" will record chest movements by camera. The program will use an algorithm to convert the chest movements into the respiratory rate | Device | Volunteers |
Primary outcome
Absolute difference between respiratory rates at different breathing spectra measured via camera
Time frame: study day 1
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole). The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
Absolute difference between respiratory rates at different breathing spectra measured via capnography
Time frame: study day 1
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole). The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
Absolute difference between respiratory rates at different breathing spectra measured via WHO standard (counting breaths for one minute)
Time frame: study day 1
The study compares respiratory rates obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole). The unit of respiratory rate is breaths per minute (e.g. 18/min) To test the accuracy of the Philips Software investigators will compare the camera-based measurements with the measurements done by capnography (as a gold standard). The statistical results will be depicted in a Bland-Altman-Plot
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 2 Dec 2016.
- Results publication: PubMed 12161291Hodgetts TJ, Kenward G, Vlachonikolis IG, Payne S, Castle N. The identification of risk factors for cardiac arrest and formulation of activation criteria to alert a medical emergency team. Resuscitation. 2002 Aug;54(2):125-31. doi: 10.1016/s0300-9572(02)00100-4.
- Results publication: PubMed 25142073Strauss R, Ewig S, Richter K, Konig T, Heller G, Bauer TT. The prognostic significance of respiratory rate in patients with pneumonia: a retrospective analysis of data from 705,928 hospitalized patients in Germany from 2010-2012. Dtsch Arztebl Int. 2014 Jul 21;111(29-30):503-8, i-v. doi: 10.3238/arztebl.2014.0503.
- Results publication: PubMed 3048900Pollack MM, Ruttimann UE, Getson PR. Pediatric risk of mortality (PRISM) score. Crit Care Med. 1988 Nov;16(11):1110-6. doi: 10.1097/00003246-198811000-00006.
- Results publication: PubMed 1597021Bone RC, Sprung CL, Sibbald WJ. Definitions for sepsis and organ failure. Crit Care Med. 1992 Jun;20(6):724-6. doi: 10.1097/00003246-199206000-00002. No abstract available.
- Results publication: PubMed 11742961Meade M, Guyatt G, Cook D, Griffith L, Sinuff T, Kergl C, Mancebo J, Esteban A, Epstein S. Predicting success in weaning from mechanical ventilation. Chest. 2001 Dec;120(6 Suppl):400S-24S. doi: 10.1378/chest.120.6_suppl.400s.
- Results publication: PubMed 8959116Mower WR, Sachs C, Nicklin EL, Safa P, Baraff LJ. A comparison of pulse oximetry and respiratory rate in patient screening. Respir Med. 1996 Nov;90(10):593-9. doi: 10.1016/s0954-6111(96)90017-7.
- Results publication: PubMed 11588210Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
- Results publication: PubMed 10403864Goldhill DR, White SA, Sumner A. Physiological values and procedures in the 24 h before ICU admission from the ward. Anaesthesia. 1999 Jun;54(6):529-34. doi: 10.1046/j.1365-2044.1999.00837.x.
- Results publication: PubMed 25745643Kellett J, Murray A, Woodworth S, Huang W. Trends in weighted vital signs and the clinical course of 44,531 acutely ill medical patients while in hospital. Acute Med. 2015;14(1):3-9.
- Results publication: PubMed 20952097Grossmann FF, Nickel CH, Christ M, Schneider K, Spirig R, Bingisser R. Transporting clinical tools to new settings: cultural adaptation and validation of the Emergency Severity Index in German. Ann Emerg Med. 2011 Mar;57(3):257-64. doi: 10.1016/j.annemergmed.2010.07.021. Epub 2010 Oct 16.
- Results publication: PubMed 25805116Venkatesh AK, Curley D, Chang Y, Liu SW. Communication of Vital Signs at Emergency Department Handoff: Opportunities for Improvement. Ann Emerg Med. 2015 Aug;66(2):125-30. doi: 10.1016/j.annemergmed.2015.02.025. Epub 2015 Mar 21.
- Results publication: PubMed 16723921Hogan J. Why don't nurses monitor the respiratory rates of patients? Br J Nurs. 2006 May 11-24;15(9):489-92. doi: 10.12968/bjon.2006.15.9.21087.
- Individual participant dataSharing planned: No
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TTN
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.
Christian Nickel, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Philips®Vital Sign Device - Camera-based system (Prototype) in people with Tachypnea, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 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 2 Dec 2016. 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 Switzerland. 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?
Absolute difference between respiratory rates at different breathing spectra measured via camera (time frame: study day 1). The study lists 3 primary outcomes in all. 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 NCT02837341, which also lists 16 linked publications.
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 2 Dec 2016.