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NCT03250065: SETT

The Sensing ET Tube

Completed NA Last updated 12 February 2018
What this trial tests

NA trial testing Application of prototype sensor to a standard endotracheal tube in Diagnostic Equipment in 16 participants. Completed in 30 September 2017.

Timeline
3 March 2017
Primary endpoint
31 July 2017
30 September 2017

Quick facts

Lead sponsorCity, University of London
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment16
Start date3 March 2017
Primary completion31 July 2017
Estimated completion30 September 2017
Sites2 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

City, University of London

Who can join

18 and older, any sex, with Diagnostic Equipment or Oximetry. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This proposal describes the development of a 'Sensing ET Tube'. This device will replace the standard endotracheal (ET) tube used in anaesthesia and in ventilated intensive care patients and provide key vital signs monitoring utilising optoelectronic sensors. Continuous monitoring of patients' arterial oxygen saturation is essential during surgery, however pulse oximeters often misread or fail altogether as a result of peripheral vasoconstriction, hypotension or hypovolaemia. The Sensing ET Tube will allow continuous measurement of oxygen saturation and other parameters, such as pulse rate, from a single internal site, and will reduce the number of surface sensors placed on the skin and the number of electrical connections to the patient. The applicants have already developed similar sensor technology in the oesophagus and other internal locations. A pilot clinical evaluation of the device will be completed in anaesthetised patients undergoing surgery. The project will lead to further development of a multi-sensor tracheal platform for comprehensive anaesthesia and intensive care monitoring.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Novel Photoplethysmography Sensor for Vital Signs Monitoring from the Human Trachea.
    May JM, Phillips JP, Fitchat T, Ramaswamy S, et al · · 2019 · cited 7× · PMID 31581652 · DOI 10.3390/bios9040119

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