Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates

Emergencies Clinical Trial

Official title:

Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates in the Triage Setting of an Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393585
• Other study ID #: Resprate 2017
• Secondary ID: EKNZ 2017-01583
• Status: Completed
• First received: December 21, 2017
• Last updated: April 20, 2018
• Start date: December 23, 2017
• Est. completion date: April 6, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: April 6, 2018
• Est. primary completion date: April 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Emergencies
• Tachypnea

Intervention

Other:
• touchless vital signs monitoring
We measure Respiratory Rates in the Triage of Patients entering an Emergency Department by three different methods.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
Christian Nickel	Philips Healthcare

Country where clinical trial is conducted

Switzerland, 

References & Publications (15)

Becker 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. 2017 Jun 1. doi: 10.1097/MEJ.0000000000000476. [Epub ahead of print] — View Citation

Bone RC, Sprung CL, Sibbald WJ. Definitions for sepsis and organ failure. Crit Care Med. 1992 Jun;20(6):724-6. — View Citation

Brabrand M, Havshøj 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. — View Citation

Edmonds ZV, Mower WR, Lovato LM, Lomeli R. The reliability of vital sign measurements. Ann Emerg Med. 2002 Mar;39(3):233-7. — View Citation

Flahault 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. — View Citation

Folke M, Cernerud L, Ekström M, Hök B. Critical review of non-invasive respiratory monitoring in medical care. Med Biol Eng Comput. 2003 Jul;41(4):377-83. Review. — View Citation

Goldhill 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. — View Citation

Grossmann 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. — View Citation

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. — View Citation

Hogan J. Why don't nurses monitor the respiratory rates of patients? Br J Nurs. 2006 May 11-24;15(9):489-92. — View Citation

Hossein 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. — View Citation

Lovett PB, Buchwald JM, Stürmann 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. — View Citation

Mower 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. — View Citation

Strauß R, Ewig S, Richter K, König 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. — View Citation

Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 year
Secondary	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)	1 year