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Camera-based Measurement of Respiratory Rates

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ClinicalTrials.gov Identifier: NCT02837341
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Clinical Trial Unit, University Hospital Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Tachypnea Device: Philips®Vital Sign Device - Camera-based system (Prototype) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Camera-based Measurement of Respiratory Rates
Study Start Date : December 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Volunteers
Monitoring of respiratory rates via camera-based System Monitoring of respiratory rate by Philips®Vital Sign Device - Camera-based system (Prototype) and capnography simultaneously.
Device: 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




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and older
  • healthy male volunteers
  • BMI 19-25

Exclusion Criteria:

  • pulmonary diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837341


Locations
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Switzerland
Intensive Care Unit, University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Clinical Trial Unit, University Hospital Basel, Switzerland
Investigators
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Principal Investigator: Christian Nickel, MD University Hospital, Basel, Switzerland
Publications of Results:

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02837341    
Other Study ID Numbers: EKNZ 2015-306
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Basel, Switzerland:
medical device
Additional relevant MeSH terms:
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Tachypnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms