EmergenciesNCT03393585
Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates
An observational study of Emergencies and Tachypnea, run by Christian Nickel at 1 site in Switzerland.
Trial summary
Respiratory rate is an important predictor for many clinical outcomes in Emergency Medicine. Nevertheless it's measurement is often omitted as it is time-consuming and cumbersome. It is the only vital sign that is not routinely assessed by a device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Tachypnea
- What is being tested?
- touchless vital signs monitoring
- How many people
- 650 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Dec 2017to 6 Apr 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will contain patients running through triage of the Emergency Department with an indication for vital sign assessment. The data will only be collected in the University Hospital of Basel.
Who may be able to join
- All walk-in patients older than 18 with a presumed ESI score of 2-3 presenting to the ED of the University Hospital of Basel will be eligible for inclusion.
Who cannot join
- Excluded will be (1) patients brought in by ambulance or helicopter, (2) unstable patients needing immediate medical treatment, (3) confused, restless, deaf patients having difficulty to follow the study instructions (4) Clear signs of refusal to participate the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates in the Triage Setting of an Emergency Department
Respiratory rate is an important predictor for many clinical outcomes in Emergency Medicine. Nevertheless it's measurement is often omitted as it is time-consuming and cumbersome. It is the only vital sign that is not routinely assessed by a device. In a pilot study was showed that a camera based monitoring system measures reliably respiratory rates in healthy volunteers.
The goal of this study is to test the accuracy of the same system in real patients in the triage setting of an Emergency Department (ED).
Read the detailed description
For triage of emergency patients at the Emergency Department of the University Hospital Basel the emergency severity index (ESI) is used. At decision point "D" in the ESI-algorithm vital signs such as respiratory rate, heart rate and oxygen saturation are needed.
According to the guidelines the respiratory rate is visually counted for one minute (WHOrecommendation) by a triage nurse.
Simultaneously in addition to the visual counting, it is planned to measure the same vital sign as part of our study also through a camera-based prototype application (CBPA) and capnography as a gold standard.
Hence the triage process is not prolongated through our study, only completed and a guideline compliant procedure is ensured which is only performed in a relatively low percentage in the ED of the University Hospital Basel. Clinical decisions are exclusively based on the actual clinical standard of visual counting and are not influenced by the measurements of our study.
For the capnography, which were considered as the most accurate method, the patient wears a nasal sample line (Philips® Heartstart MRx mit Philips® Smart CapnoLine™PlusO2Long Oral/Nasal Sample Line).
The CBPA system consists of a notebook (HP Zbook 15 G3, S/N: CND705IXT6), USB-camera with lens (Tamron CCTV lens, CE 4402789484; UI3060 camera, 20170329-E347840), USB-harddrive (Western digital R/N D8B, S/N: WXA1E661J0XJ) to save the signals and an implement camera-based algorithm for extraction of breathing signals. The camera is pointing towards the torso of the patient to display it on the screen in a real-time application. The software is able to detect the respiratory-specific chest movements and generates a respiratory wave on the computer. From the configuration and frequency of these respiratory waves the software calculates the respiratory rate. No videos are recorded.
The data is acquired in a standardised protocol and stored coded in an Access®-database. To prevent potential bias the vital signs will be written down in the following order: 1. RR by visual counting 2. RR by CBPA 3. RR by capnography. The measurements take place in rooms of the ED which are designated to triage emergency patients.
As possible confounders sex, age and BMI are registered.
- Conditions
- Emergencies, Tachypnea
- Being tested
- touchless vital signs monitoring
- Keywords
- Respiratory Rates
- Medical subject headings
- Emergencies, Tachypnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
touchless vital signs monitoringOther
We measure Respiratory Rates in the Triage of Patients entering an Emergency Department by three different methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of the camera based prototype application (CBPA)
In this study respiratory rates are 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). We want to study the Specificity and sensitivity of the CBPA compared to the gold standard (capnography)
Measured: 1 year
Secondary outcomes (1)
Upgrade of patient's ESI level due to CBPA (from Level 3 to 2)
Number of Patients with a RR measured by CBPA higher than 20 leading to an upgrade at decision Point D of the Triage algorithm (ESI)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start23 Dec 2017
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Nickel
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor-investigator, Christian Nickel, University Hospital, Basel, Switzerland
- Investigators
- Christian H Nickel, PD Dr. med, Principal investigator, Emergency Department, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393585
- Sponsor's protocol ID
- Resprate 2017
- Other IDs
- EKNZ 2017-01583
- Status last verified
- Apr 2018
- First submitted
- 21 Dec 2017
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 25142073Bone 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 1597021Brabrand M, Havshoj U, Graham CA. Validation of the qSOFA score for identification of septic patients: A retrospective study. Eur J Intern Med. 2016 Dec;36:e35-e36. doi: 10.1016/j.ejim.2016.09.004. Epub 2016 Sep 15. No abstract available.
PubMed 27640097Mower 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 10403864Grossmann 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 20952097Hossein Nejad H, Banaie M, Seyedhosseini Davarani SH, Khazaeipour Z. Evaluation of the Significance of Vital Signs in the Up-Triage of Patients Visiting Emergency Department from Emergency Severity Index Level 3 to 2. Acta Med Iran. 2016 Jun;54(6):366-9.
PubMed 27306342Hogan 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 11867974Folke M, Cernerud L, Ekstrom M, Hok B. Critical review of non-invasive respiratory monitoring in medical care. Med Biol Eng Comput. 2003 Jul;41(4):377-83. doi: 10.1007/BF02348078.
PubMed 12892358Becker C, Achermann S, Rocque M, Kirenko I, Schlack A, Dreher-Hummel T, Zumbrunn T, Bingisser R, Nickel CH. Camera-based measurement of respiratory rates is reliable. Eur J Emerg Med. 2018 Dec;25(6):416-422. doi: 10.1097/MEJ.0000000000000476.
PubMed 28574856Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009.
PubMed 16018921
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates in the Triage Setting of an Emergency Department
- ClinicalTrials.gov ID
- NCT03393585
- Acronym / sponsor ID
- Resprate 2017
- Conditions
- Emergencies, Tachypnea
- Keywords
- Respiratory Rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Christian NickelUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 8 Jan 2018 (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.
Respiratory rate is an important predictor for many clinical outcomes in Emergency Medicine. Nevertheless it's measurement is often omitted as it is time-consuming and cumbersome. It is the only vital sign that is not routinely assessed by a device. In a pilot study was showed that a camera based monitoring system measures reliably respiratory rates in healthy volunteers.
The goal of this study is to test the accuracy of the same system in real patients in the triage setting of an Emergency Department (ED).
Detailed description
For triage of emergency patients at the Emergency Department of the University Hospital Basel the emergency severity index (ESI) is used. At decision point "D" in the ESI-algorithm vital signs such as respiratory rate, heart rate and oxygen saturation are needed.
According to the guidelines the respiratory rate is visually counted for one minute (WHOrecommendation) by a triage nurse.
Simultaneously in addition to the visual counting, it is planned to measure the same vital sign as part of our study also through a camera-based prototype application (CBPA) and capnography as a gold standard.
Hence the triage process is not prolongated through our study, only completed and a guideline compliant procedure is ensured which is only performed in a relatively low percentage in the ED of the University Hospital Basel. Clinical decisions are exclusively based on the actual clinical standard of visual counting and are not influenced by the measurements of our study.
For the capnography, which were considered as the most accurate method, the patient wears a nasal sample line (Philips® Heartstart MRx mit Philips® Smart CapnoLine™PlusO2Long Oral/Nasal Sample Line).
The CBPA system consists of a notebook (HP Zbook 15 G3, S/N: CND705IXT6), USB-camera with lens (Tamron CCTV lens, CE 4402789484; UI3060 camera, 20170329-E347840), USB-harddrive (Western digital R/N D8B, S/N: WXA1E661J0XJ) to save the signals and an implement camera-based algorithm for extraction of breathing signals. The camera is pointing towards the torso of the patient to display it on the screen in a real-time application. The software is able to detect the respiratory-specific chest movements and generates a respiratory wave on the computer. From the configuration and frequency of these respiratory waves the software calculates the respiratory rate. No videos are recorded.
The data is acquired in a standardised protocol and stored coded in an Access®-database. To prevent potential bias the vital signs will be written down in the following order: 1. RR by visual counting 2. RR by CBPA 3. RR by capnography. The measurements take place in rooms of the ED which are designated to triage emergency patients.
As possible confounders sex, age and BMI are registered.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will contain patients running through triage of the Emergency Department with an indication for vital sign assessment. The data will only be collected in the University Hospital of Basel.
Key inclusion criteria (1 listed)
- All walk-in patients older than 18 with a presumed ESI score of 2-3 presenting to the ED of the University Hospital of Basel will be eligible for inclusion.
Key exclusion criteria (1 listed)
- Excluded will be (1) patients brought in by ambulance or helicopter, (2) unstable patients needing immediate medical treatment, (3) confused, restless, deaf patients having difficulty to follow the study instructions (4) Clear signs of refusal to participate the study.
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 |
|---|---|---|
| touchless vital signs monitoringWe measure Respiratory Rates in the Triage of Patients entering an Emergency Department by three different methods. | Other | – |
Primary outcome
Specificity and sensitivity of the camera based prototype application (CBPA)
Time frame: 1 year
In this study respiratory rates are 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). We want to study the Specificity and sensitivity of the CBPA compared to the gold standard (capnography)
1 secondary outcome
Upgrade of patient's ESI level due to CBPA (from Level 3 to 2)
Time frame: 1 year
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 23 Apr 2018.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 27640097Brabrand M, Havshoj U, Graham CA. Validation of the qSOFA score for identification of septic patients: A retrospective study. Eur J Intern Med. 2016 Dec;36:e35-e36. doi: 10.1016/j.ejim.2016.09.004. Epub 2016 Sep 15. No abstract available.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 27306342Hossein Nejad H, Banaie M, Seyedhosseini Davarani SH, Khazaeipour Z. Evaluation of the Significance of Vital Signs in the Up-Triage of Patients Visiting Emergency Department from Emergency Severity Index Level 3 to 2. Acta Med Iran. 2016 Jun;54(6):366-9.
- Background: 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.
- Background: PubMed 15635313Lovett 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.
- Background: PubMed 11867974Edmonds 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.
- Individual participant dataSharing planned: No
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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.
Christian H Nickel, PD Dr. med principal investigator
Emergency Department, University Hospital Basel
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 Emergencies and Tachypnea, run by Christian Nickel 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 1 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 23 Apr 2018. 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?
Specificity and sensitivity of the camera based prototype application (CBPA) (time frame: 1 year). 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 NCT03393585, which also lists 17 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 23 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.