Camera-based Measurement of Respiratory Rates

NCT02837341 | Completed DMC

• 1 other identifier: EKNZ 2015-306
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachypnea

Keywords

medical device

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  study day 1

Study Arms (1)

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.

Device: Philips®Vital Sign Device - Camera-based system (Prototype)

Interventions

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

Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pulmonary diseases

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

Intensive Care Unit, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (16)

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MeSH Terms

Conditions

Tachypnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Nickel, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: July 19, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 2, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)