The Sensing ET Tube (SETT)

February 8, 2018 updated by: City, University of London

Development of the "Sensing Endotracheal Tube": an Optical Multi-parameter Monitoring System.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of this project is to develop and evaluate a novel medical device known as the 'Sensing ET Tube' for measuring oxygen levels in patients undergoing surgical operations. The device replaces the standard breathing tube used in surgery and incorporates photonic sensors for measurement of the patient's oxygen level and other vital signs. Currently this information is supplied from finger probes, which can fail often, for example when the patient is cold or when the blood pressure is low. The new device is completely harmless and allows the anaesthetist to monitor the oxygen level from the central region of the body using minimal connections. If successful, future work is planned to incorporate other sensors into the system, providing a complete overview of the health of the patient. This will greatly simplify the process of patient monitoring while reducing the number of failures, improving patient safety and reducing operating costs.

A clinical trial is planned in up to 50 patients undergoing general anaesthesia, which will quantitatively evaluate the accuracy and reliability of the measured clinical variables and the device's expected performance in mainstream operation. This information will provide the basis for further commercial development, most likely through partnership with a medical device manufacturer.

To summarise, the main aims of the project are:

  • Investigate photoplethysmographic signals from the human trachea and identify viability to measure heart rate, and blood oxygen saturation by comparison with "gold standard" techniques.
  • Evaluate custom-designed endotracheal sensor for operation and determine ideal electrical characteristics for optimal operation (current supply, detector amplification etc.)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Barts and The London NHS Trust
      • London, United Kingdom, EC1V0HB
        • City, University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ETT Study Group
The Sensing ET Tube study Group
Device: Application of prototype sensor to a standard endotracheal tube
During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To validate the pulse oximetry signals from the trachea during anaesthesia for their suitability in determining vital signs, not limited to just oxygen saturation.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City, University of London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Barts & The London NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saowarat Snidvongs, MD, Barts and The London NHS Trust
  • Study Director: Justin Phillips, PhD, City, University of London
  • Study Chair: Panayiotis A Kyriacou, PhD, City, University of London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCBE/2015/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all data is anonymised and raw signals are only shared among the named investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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