NCT02374554

Brief Summary

Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient. Various devices using different techniques are available to measure RR. One technique, capnography, uses continuous monitoring of expired gases, via a nasal cannula to assess end tidal CO2 concentration. This long-established technique is frequently used for patients in intensive care. Both RR and the shape of the capnogram waveform, which has a wave pattern marked by alternating inspiratory and expiratory phases, are used to help monitor the patient. Clinician Over-scored End Tidal C02 (COSC) waveform (whereby an expert identifies and scores each breath on the waveform and counts the number of breaths per minute) is considered to be a "gold standard" for measuring RR. Being able to record RR, without contact or interference with the patient is appealing because it requires minimal patient co-operation, enables measurements even during acute respiratory conditions, and may be more representative of "real life" physiology. Based on a principle originally described in the 1980s, a novel instrument that uses a completely non-contact system based on structured light plethysmography (SLP) has recently been designed by Cambridge University Hospitals Foundation Trust. The device has been refined with the development of the Thora-3Di by Pneumacare Ltd, Cambridge. A grid of visible light is projected onto the thoraco-abdominal wall and two digital video cameras record changes in the grid pattern due to breathing motion. A waveform is produced by the anterior excursion of the thoraco-abdominal wall (SLPVol) over time, and a numerical output of RR is provided . The present study aims to simultaneously measure tidal breathing with the Thora-3Di and a BCI Capnograph 9004 device to compare the Thora-3Di RR output against that of the gold standard clinician over-scored end-tidal C02 (COSC) and to assess equivalence of the two devices with the aim to establishing the validity of SLP for RR measurement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

February 23, 2015

Last Update Submit

March 5, 2015

Conditions

Pulmonary Disease

Keywords

Respiratory RateStructured Light PlethysmographyCapnography

Outcome Measures

Primary Outcomes (1)

  • The root mean squared difference (RMSD) in Respiratory Rate between the test (Thora-3Di) and reference Device (COSC)

    The test device will be accepted as sufficiently accurate if the RMSD is significantly less than 0.9 brpm (significance level 0.05, power 0.8)

    1 minute (randomly selected) of a 5 minute measurement period

Study Arms (1)

Respiratory Rate Measurement Comparision

OTHER

To demonstrate equivalence of the Thora-3Di Structured Light Plethysmography device and a Clinician Over-scored End Tidal C02 (COSC)derived from a BCI Capnograph 9004 (Smiths Medical) for measurement of Respiratory Rate

Device: Structured Light Plethysmography (Thora-3Di)Device: BCI Capnograph 9004 (Smiths Medical)

Interventions

Structured Light Plethysmography (Thora-3Di)DEVICE

Respiratory Rate measured by Structured Light Plethysmography Thora-3Di and Clinician Over-scored End Tidal C02 (COSC) during 1 randomised minute of a 5 minute measurement period

Also known as: Thora-3Di Structured Light Plethysmography
Respiratory Rate Measurement Comparision
BCI Capnograph 9004 (Smiths Medical)DEVICE

Respiratory Rate measured by Structured Light Plethysmography Thora-3Di and Clinician Over-scored End Tidal C02 (COSC) during 1 randomised minute of a 5 minute measurement period

Also known as: Capnocheck (Smiths Medical)
Respiratory Rate Measurement Comparision

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female,
  • Age range 18-80 years,
  • BMI range 18-40 kg/m2
  • Patients with respiratory disease or breathing impairment (Patient Group) or normal subjects with no previous or current diagnosis of respiratory disease (Normals group)

You may not qualify if:

  • Patient unable to sit in an upright position for required period of time
  • Patients with significant co morbidities (assessed by the clinician at screening only):
  • Significant unilateral lung disease e.g. pneumonectomy
  • Chest wall or spinal deformity e.g. scoliosis
  • Obstructive Sleep Apnoea, Apnoea hypopnoea index \> 30 (if known)
  • BMI\>40
  • Inability to consent/comply with trial protocol
  • Presence of an acute disease process that might interfere with test performance (e.g. Nausea, vomiting, persistent coughing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Stowhealth

Stowmarket, Suffolk, IP14 1NL, United Kingdom

RECRUITING

Related Publications (12)

  • Bland JM. Sample size in guidelines trials. Fam Pract. 2000 Feb;17 Suppl 1:S17-20. doi: 10.1093/fampra/17.suppl_1.s17.

    PMID: 10735263BACKGROUND

  • Cretikos MA, Bellomo R, Hillman K, Chen J, Finfer S, Flabouris A. Respiratory rate: the neglected vital sign. Med J Aust. 2008 Jun 2;188(11):657-9. doi: 10.5694/j.1326-5377.2008.tb01825.x.

    PMID: 18513176BACKGROUND

  • Gaucher A, Frasca D, Mimoz O, Debaene B. Accuracy of respiratory rate monitoring by capnometry using the Capnomask(R) in extubated patients receiving supplemental oxygen after surgery. Br J Anaesth. 2012 Feb;108(2):316-20. doi: 10.1093/bja/aer383. Epub 2011 Dec 11.

    PMID: 22157953BACKGROUND

  • Jaffe MB. Infrared measurement of carbon dioxide in the human breath: "breathe-through" devices from Tyndall to the present day. Anesth Analg. 2008 Sep;107(3):890-904. doi: 10.1213/ane.0b013e31817ee3b3.

    PMID: 18713902BACKGROUND

  • Kodali BS. Capnography outside the operating rooms. Anesthesiology. 2013 Jan;118(1):192-201. doi: 10.1097/ALN.0b013e318278c8b6. No abstract available.

    PMID: 23221867BACKGROUND

  • Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. doi: 10.1136/thx.39.2.101.

    PMID: 6701820BACKGROUND

  • Storm-Versloot MN, Verweij L, Lucas C, Ludikhuize J, Goslings JC, Legemate DA, Vermeulen H. Clinical relevance of routinely measured vital signs in hospitalized patients: a systematic review. J Nurs Scholarsh. 2014 Jan;46(1):39-49. doi: 10.1111/jnu.12048. Epub 2013 Oct 11.

    PMID: 24124656BACKGROUND

  • Yanagidate F, Dohi S. Modified nasal cannula for simultaneous oxygen delivery and end-tidal CO2 monitoring during spontaneous breathing. Eur J Anaesthesiol. 2006 Mar;23(3):257-60. doi: 10.1017/S0265021505002279.

    PMID: 16430798BACKGROUND

  • Box, Hunter and Hunter (1978). Statistics for experimenters. Wiley. p118. ISBN 0471093157

    BACKGROUND

  • de Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. SLP: a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B, eds, Proceedings of the British Machine Vision Conference. BMVA Press, 2010; pp 85.1-85.12

    BACKGROUND

  • Johnson NL, Kotz S, Balakrishnan N. 1970. Continuous Univariate Distributions, Volume 2, Wiley.

    BACKGROUND

  • Smith I, Mackay J, Fahrid N, Krucheck D. Respiratory rate measurement: a comparison of methods. British Journal of Healthcare Assistants 2011; 5: 18-23

    BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Richard Iles, MD

    Cambridge University Hospitals Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel C Wilson, PhD

CONTACT

07907 071978rachel.wilson@pneumacare.com

Iles, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 2, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

GB(2)