Diagnostic EquipmentSETTNCT03250065
The Sensing ET Tube
A study testing Application of prototype sensor to a standard endotracheal tube in people with Diagnostic Equipment and Oximetry, run by City, University of London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Equipment, Oximetry, Pulse Rate
- What is being tested?
- Application of prototype sensor to a standard endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Mar 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-III
- 18 Years and older
- Undergoing elective surgery requiring general anaesthesia, and endotracheal tube as part of their anaesthetic.
Who cannot join
- Those who refuse consent
- Known or potentially difficult airway
- Respiratory conditions including severe asthma, COPD, lung cancer etc.
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
City, University of London
London, EC1V0HB
Barts and The London NHS Trust
London
About this study
Official title: 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.
Read the 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.)
- Conditions
- Diagnostic Equipment, Oximetry, Pulse Rate
- Being tested
- Application of prototype sensor to a standard endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of prototype sensor to a standard endotracheal tubeDevice
During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.
| Study group | Role | What they receive |
|---|---|---|
| ETT Study Group | Experimental | The Sensing ET Tube study Group Receives: Device: Application of prototype sensor to a standard endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start3 Mar 2017
- Primary completion31 Jul 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic EquipmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Sponsor
- Investigators
- Saowarat Snidvongs, MD, Principal investigator, Barts and The London NHS TrustJustin Phillips, PhD, Study director, City, University of LondonPanayiotis A Kyriacou, PhD, Study chair, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250065
- Sponsor's protocol ID
- RCBE/2015/01
- Acronym
- SETT
- Status last verified
- Feb 2018
- First submitted
- 9 Aug 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data is anonymised and raw signals are only shared among the named investigators
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the "Sensing Endotracheal Tube": an Optical Multi-parameter Monitoring System.
- ClinicalTrials.gov ID
- NCT03250065
- Acronym / sponsor ID
- SETT / RCBE/2015/01
- Conditions
- Diagnostic Equipment, Oximetry, Pulse Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ETT Study Group | Experimental | Device: Application of prototype sensor to a standard endotracheal tubeThe Sensing ET Tube study Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- 18 Years and older
- Undergoing elective surgery requiring general anaesthesia, and endotracheal tube as part of their anaesthetic.
Key exclusion criteria (4 listed)
- Those who refuse consent
- Known or potentially difficult airway
- Respiratory conditions including severe asthma, COPD, lung cancer etc.
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of prototype sensor to a standard endotracheal tubeDuring anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal. | Device | ETT Study Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Individual participant dataSharing planned: No. all data is anonymised and raw signals are only shared among the named investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saowarat Snidvongs, MD principal investigator
Barts and The London NHS Trust
Justin Phillips, PhD study director
City, University of London
Panayiotis A Kyriacou, PhD study chair
City, University of London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of prototype sensor to a standard endotracheal tube in people with Diagnostic Equipment and Oximetry, run by City, University of London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.