The Sensing ET Tube

NCT03250065 | Completed DMC

• 1 other identifier: RCBE/2015/01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diagnostic Equipment; Oximetry; Pulse Rate

Outcome Measures

Primary Outcomes (1)

• To validate the pulse oximetry signals from the trachea during anaesthesia for their suitability in determining vital signs, not limited to just oxygen saturation.

  Raw optical electrical signals related to the absorbion of red and infrared light from the prototype sensor by the tissue in the trachea will be assessed for their viability to reliable determine pulse rate and oxygen saturation compared to the standard clinical devices during surgery. The signals will be further analysed to look for correlation with recorded blood pressure measurents and respiration rates.

  1 year

Study Arms (1)

ETT Study Group

EXPERIMENTAL

The Sensing ET Tube study Group

Device: Application of prototype sensor to a standard endotracheal tube

Interventions

Application of prototype sensor to a standard endotracheal tube DEVICE

During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.

ETT Study Group

Eligibility Criteria

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

You may qualify if:

• ASA I-III
• Years and older
• Undergoing elective surgery requiring general anaesthesia, and endotracheal tube as part of their anaesthetic.

You may not qualify if:

• Those who refuse consent
• Known or potentially difficult airway
• Respiratory conditions including severe asthma, COPD, lung cancer etc.
• Pregnant women

Sponsors & Collaborators

• City, University of London: lead
• Barts & The London NHS Trust: collaborator

Study Sites (2)

City, University of London

London, EC1V0HB, United Kingdom

Location

Barts and The London NHS Trust

London, United Kingdom

Location

Study Officials

• Saowarat Snidvongs, MD

  Barts and The London NHS Trust

  PRINCIPAL INVESTIGATOR

• Justin Phillips, PhD

  City, University of London

  STUDY DIRECTOR

• Panayiotis A Kyriacou, PhD

  City, University of London

  STUDY CHAIR

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: August 9, 2017
• First Posted: August 15, 2017
• Study Start: March 3, 2017
• Primary Completion: July 31, 2017
• Study Completion: September 30, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)