NCT03393585

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 23, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

3 months

First QC Date

December 21, 2017

Last Update Submit

April 20, 2018

Conditions

Keywords

Respiratory Rates

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Upgrade of patient's ESI level due to CBPA (from Level 3 to 2)

    1 year

Interventions

We measure Respiratory Rates in the Triage of Patients entering an Emergency Department by three different methods.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (17)

  • 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.

    PMID: 12161291BACKGROUND
  • Strauss 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.

    PMID: 25142073BACKGROUND
  • Bone 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.

    PMID: 1597021BACKGROUND
  • Brabrand 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.

    PMID: 27640097BACKGROUND
  • 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. doi: 10.1016/s0954-6111(96)90017-7.

    PMID: 8959116BACKGROUND
  • 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. doi: 10.1093/qjmed/94.10.521.

    PMID: 11588210BACKGROUND
  • 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. doi: 10.1046/j.1365-2044.1999.00837.x.

    PMID: 10403864BACKGROUND
  • 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.

    PMID: 20952097BACKGROUND
  • 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.

    PMID: 27306342BACKGROUND
  • Hogan 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.

    PMID: 16723921BACKGROUND
  • Lovett 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.

    PMID: 15635313BACKGROUND
  • Edmonds 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.

    PMID: 11867974BACKGROUND
  • Folke 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.

    PMID: 12892358BACKGROUND
  • 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. 2018 Dec;25(6):416-422. doi: 10.1097/MEJ.0000000000000476.

    PMID: 28574856BACKGROUND
  • 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. doi: 10.1016/j.jclinepi.2004.12.009.

    PMID: 16018921BACKGROUND
  • Caspar M, Dutilh G, Achermann S, Bingisser R, Nickel CH. Contact-Free Monitoring of Pulse Rate For Triage of Patients Presenting to the Emergency Department. J Emerg Med. 2021 Dec;61(6):649-657. doi: 10.1016/j.jemermed.2021.07.005. Epub 2021 Aug 30.

  • Achermann S, Caspar M, Wirth C, Becker C, Rocque M, Kirenko I, Schlack A, Dutilh G, Bingisser R, Nickel CH. Contact-free monitoring of respiratory rates for triage of patients presenting to the emergency department. Resuscitation. 2019 Apr;137:154-155. doi: 10.1016/j.resuscitation.2019.01.041. Epub 2019 Feb 18. No abstract available.

MeSH Terms

Conditions

EmergenciesTachypnea

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Christian H Nickel, PD Dr. med

    Emergency Department, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD MD

Study Record Dates

First Submitted

December 21, 2017

First Posted

January 8, 2018

Study Start

December 23, 2017

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations