TracheostomySEACtVNCT04647786
Safe and Effective Above Cuff Tracheostomy Ventilation
A study testing Prototype medical device (SEA CtV) in people with Tracheostomy, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A Phase I study of an 'in-house' developed, novel, Class I, prototype medical device to facilitate vocalisation in participants with cuff-inflated tracheostomy tubes. Primary objective: To design and develop a device to deliver Above Cuff Vocalisation (ACV) that is safe, well tolerated and effective at producing a… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy
- What is being tested?
- Prototype medical device (SEA CtV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jul 2022to 31 Dec 2024
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- cuff-inflated tracheosotmy tube in situ for >48 hours
- managed on an Intensive Care Unit at MFT
- Male and females
- Aged 18-100; patient is alert and attempting to communicate (and thus able to participate in the consent process).
- Provision of informed consent
- bedside clinical staff (medical, nursing, allied healthcare professional) who manage the patient during routine clinical duties whilst ACV is in progress.
Who cannot join
- Exclusion criteria (patient): Participants must not enter the study if any of the following exclusion criteria are fulfilled:
- Patient refusal
- ACV is not indicated in the opinion of the parent clinical team
- Patient has (or is suspected to have) an altered and therefore potentially obstructed upper airway
- Patient has (or is suspected to have) an active and currently infectious high-consequence respiratory infection that could be transmitted by aerosolisation (eg COVID-19)
- Clinical condition has progressed so that the patient is tolerating cuff deflation and a speaking valve well and is able to voice effectively (ie without ACV: this negates the requirement for an ACV trial); Contraindications to FEES (adapted from RCSLT FEES policy) o Base of skull / facial fracture; Severe/life threatening epistaxis within the last 6 weeks; Trauma to nasal cavity secondary to surgery or injury within the last 6 weeks; Sino-nasal and anterior skull base tumours / surgery; Nasopharyngeal stenosis; Craniofacial anomalies; Hereditary Haemorrhagic telangiectasia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation trust
Manchester, M23 9LT
About this study
Official title: Safe and Effective Above Cuff Tracheostomy Ventilation - a Device Development Study
A Phase I study of an 'in-house' developed, novel, Class I, prototype medical device to facilitate vocalisation in participants with cuff-inflated tracheostomy tubes.
Primary objective: To design and develop a device to deliver Above Cuff Vocalisation (ACV) that is safe, well tolerated and effective at producing a voice in tracheostomised patients in the Intensive Care Unit (ICU).
Secondary objective: To evaluate whether more effective delivery of ACV has a significant impact on laryngeal function and recovery following new tracheostomy in ICU patients.
Read the detailed description
A tracheostomy is an artificial airway inserted into the trachea (windpipe) through the front of the neck, usually required for prolonged artificial ventilation in the critically ill. Between 10-15% of the 250,000 patients admitted annually to UK Intensive Care Units (ICUs) require temporary tracheostomy, with an additional 5,000 tracheostomies performed during surgery. The tubes have a cuff/balloon which seals the trachea when inflated, allowing lung ventilation. The flow of gas into and out of the patient's lungs does not flow through the upper airways (nose and mouth), bypassing the larynx (voice box) and preventing speech. Our research found the biggest problem with tracheostomies from the patient's perspective is losing the ability to speak. If the muscles of the larynx and throat are not used, they quickly become weak, meaning that coughing, swallowing and talking can take longer to recover. These problems cause anger, frustration, fear and low mood and lead to significantly longer hospital stays, impacting ICU and hospital bed availability.
Patients with a weak cough or swallow cannot clear secretions from the throat, which may enter the lungs (aspiration). The inflated cuff reduces aspiration and most ICU-specific tubes have an extra suction-port for secretion removal. However, additional gas can be directed via the suction-port, through the vocal cords and out via the upper airways, allowing vocalisation. The MHRA confirmed these tubes can be used for 'above cuff voicing' (ACV) in line with their CE marking.
Our proposed research advances healthcare technologies by developing a new clinically validated prototype medical device with the potential to significantly increase patient benefit for a defined and expanding area of clinical need. Our collaborative project combines our clinical experience and understanding of the needs of tracheostomy patients and their families with the design and engineering excellence of our University and SME partners. Our team is supported by individual and institutional research expertise and together with our patient partners, we can deliver an advanced prototype device with a clear pathway towards adoption and commercialisation, attractive to follow-on funders and investors.
- Conditions
- Tracheostomy
- Being tested
- Prototype medical device (SEA CtV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype medical device (SEA CtV)Device
A prototype device that delivers a controlled flow of gas to the upper airways via the subglottic suction port of an established tracheostomy tube. Gas flow may be timed, warmed and/or humidified.
| Study group | Role | What they receive |
|---|---|---|
| Humidified and Augmented gas flows | Experimental | Not described Receives: Device: Prototype medical device (SEA CtV) |
| Humidified but not Augmented gas flows | Experimental | Not described Receives: Device: Prototype medical device (SEA CtV) |
| Not Humidified but Augmented gas flows | Experimental | Not described Receives: Device: Prototype medical device (SEA CtV) |
| Neither humidified nor augmented gas flows | No intervention | Not described |
| Use of finalised device (SEA CtV) in final phase | Experimental | Not described Receives: Device: Prototype medical device (SEA CtV) |
| Standard care (no SEA CtV) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of vocalisation (Patient-reported voice VAS)
To assess the effectiveness of the SEA CtV prototype device in producing a voice for cuff-inflated tracheostomy patients.
Measured: Daily for up to 7 days
Secondary outcomes (4)
Voice rating
(Objective scales FCS, NoWS, TOMS, GRBAS, recordings for volume and intelligibility); Cough count; Swallow count; e-Stim (threshold/max sensetivities); FEES (Laryngeal function scales Pen-Asp, SSRS, APS)
Measured: Daily for up to 7 days
Adverse events record
Adverse events record (tracheosotmy tube displacement, surgical emphysema), adverse events log, setup safety tests (does the device stop appropriately)
Measured: Daily for up to 7 days
Patient reported subjective tolerability
Patient-reported subjective tolerability VAS; Staff-reported objective tolerability VAS; Patient-reported problems; ACV device use
Measured: Daily for up to 7 days
Time to first oral intake
Time to oral intake; Functional Swallowing Outcome; vocalisation; cuff deflation for >2 hours; ETT days; Trachy days; ICU days; hospital days; CCMDS organ supoort data
Measured: Daily for up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start13 Jul 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 3 phases: 1. Safety testing in sequential patients 2. 2x2 factorial design 3. Simple unblinded RCT using finalised device vs standard care
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647786
- Sponsor's protocol ID
- B00990
- Acronym
- SEACtV
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The project will generate confidential patient data and commercially sensitive IP data. Summaries of these data will be shared publicly.
Publications
McGrath BA, Wallace S, Wilson M, Nicholson L, Felton T, Bowyer C, Bentley AM. Safety and feasibility of above cuff vocalisation for ventilator-dependant patients with tracheostomies. J Intensive Care Soc. 2019 Feb;20(1):59-65. doi: 10.1177/1751143718767055. Epub 2018 Mar 28.
PubMed 30792764Zaga CJ, Pandian V, Brodsky MB, Wallace S, Cameron TS, Chao C, Orloff LA, Atkins NE, McGrath BA, Lazarus CL, Vogel AP, Brenner MJ. Speech-Language Pathology Guidance for Tracheostomy During the COVID-19 Pandemic: An International Multidisciplinary Perspective. Am J Speech Lang Pathol. 2020 Aug 4;29(3):1320-1334. doi: 10.1044/2020_AJSLP-20-00089. Epub 2020 Jun 11.
PubMed 32525695McGrath B, Lynch J, Wilson M, Nicholson L, Wallace S. Above cuff vocalisation: A novel technique for communication in the ventilator-dependent tracheostomy patient. J Intensive Care Soc. 2016 Feb;17(1):19-26. doi: 10.1177/1751143715607549. Epub 2015 Oct 5.
PubMed 28979454
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe and Effective Above Cuff Tracheostomy Ventilation - a Device Development Study
- ClinicalTrials.gov ID
- NCT04647786
- Acronym / sponsor ID
- SEACtV / B00990
- Conditions
- Tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Manchester Metropolitan University
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Dec 2020 (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.
A Phase I study of an 'in-house' developed, novel, Class I, prototype medical device to facilitate vocalisation in participants with cuff-inflated tracheostomy tubes.
Primary objective: To design and develop a device to deliver Above Cuff Vocalisation (ACV) that is safe, well tolerated and effective at producing a voice in tracheostomised patients in the Intensive Care Unit (ICU).
Secondary objective: To evaluate whether more effective delivery of ACV has a significant impact on laryngeal function and recovery following new tracheostomy in ICU patients.
Detailed description
A tracheostomy is an artificial airway inserted into the trachea (windpipe) through the front of the neck, usually required for prolonged artificial ventilation in the critically ill. Between 10-15% of the 250,000 patients admitted annually to UK Intensive Care Units (ICUs) require temporary tracheostomy, with an additional 5,000 tracheostomies performed during surgery. The tubes have a cuff/balloon which seals the trachea when inflated, allowing lung ventilation. The flow of gas into and out of the patient's lungs does not flow through the upper airways (nose and mouth), bypassing the larynx (voice box) and preventing speech. Our research found the biggest problem with tracheostomies from the patient's perspective is losing the ability to speak. If the muscles of the larynx and throat are not used, they quickly become weak, meaning that coughing, swallowing and talking can take longer to recover. These problems cause anger, frustration, fear and low mood and lead to significantly longer hospital stays, impacting ICU and hospital bed availability.
Patients with a weak cough or swallow cannot clear secretions from the throat, which may enter the lungs (aspiration). The inflated cuff reduces aspiration and most ICU-specific tubes have an extra suction-port for secretion removal. However, additional gas can be directed via the suction-port, through the vocal cords and out via the upper airways, allowing vocalisation. The MHRA confirmed these tubes can be used for 'above cuff voicing' (ACV) in line with their CE marking.
Our proposed research advances healthcare technologies by developing a new clinically validated prototype medical device with the potential to significantly increase patient benefit for a defined and expanding area of clinical need. Our collaborative project combines our clinical experience and understanding of the needs of tracheostomy patients and their families with the design and engineering excellence of our University and SME partners. Our team is supported by individual and institutional research expertise and together with our patient partners, we can deliver an advanced prototype device with a clear pathway towards adoption and commercialisation, attractive to follow-on funders and investors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 3 phases: 1. Safety testing in sequential patients 2. 2x2 factorial design 3. Simple unblinded RCT using finalised device vs standard care
| Arm | Type | Receives |
|---|---|---|
| Humidified and Augmented gas flows | Experimental | Device: Prototype medical device (SEA CtV) |
| Humidified but not Augmented gas flows | Experimental | Device: Prototype medical device (SEA CtV) |
| Not Humidified but Augmented gas flows | Experimental | Device: Prototype medical device (SEA CtV) |
| Neither humidified nor augmented gas flows | No intervention | – |
| Use of finalised device (SEA CtV) in final phase | Experimental | Device: Prototype medical device (SEA CtV) |
| Standard care (no SEA CtV) | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent prior to any study specific procedures
- cuff-inflated tracheosotmy tube in situ for >48 hours
- managed on an Intensive Care Unit at MFT
- Male and females
- Aged 18-100; patient is alert and attempting to communicate (and thus able to participate in the consent process).
Key exclusion criteria (6 listed)
- Exclusion criteria (patient): Participants must not enter the study if any of the following exclusion criteria are fulfilled:
- Patient refusal
- ACV is not indicated in the opinion of the parent clinical team
- Patient has (or is suspected to have) an altered and therefore potentially obstructed upper airway
- Patient has (or is suspected to have) an active and currently infectious high-consequence respiratory infection that could be transmitted by aerosolisation (eg COVID-19)
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 |
|---|---|---|
| Prototype medical device (SEA CtV)A prototype device that delivers a controlled flow of gas to the upper airways via the subglottic suction port of an established tracheostomy tube. Gas flow may be timed, warmed and/or humidified. | Device | Humidified and Augmented gas flows, Humidified but not Augmented gas flows, Not Humidified but Augmented gas flows, Use of finalised device (SEA CtV) in final phase |
Primary outcome
Effectiveness of vocalisation (Patient-reported voice VAS)
Time frame: Daily for up to 7 days
To assess the effectiveness of the SEA CtV prototype device in producing a voice for cuff-inflated tracheostomy patients.
4 secondary outcomes
Voice rating
Time frame: Daily for up to 7 days
Adverse events record
Time frame: Daily for up to 7 days
Patient reported subjective tolerability
Time frame: Daily for up to 7 days
Time to first oral intake
Time frame: Daily for up to 7 days
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 20 Jan 2025.
- Results publication: PubMed 30792764McGrath BA, Wallace S, Wilson M, Nicholson L, Felton T, Bowyer C, Bentley AM. Safety and feasibility of above cuff vocalisation for ventilator-dependant patients with tracheostomies. J Intensive Care Soc. 2019 Feb;20(1):59-65. doi: 10.1177/1751143718767055. Epub 2018 Mar 28.
- Results publication: PubMed 32525695Zaga CJ, Pandian V, Brodsky MB, Wallace S, Cameron TS, Chao C, Orloff LA, Atkins NE, McGrath BA, Lazarus CL, Vogel AP, Brenner MJ. Speech-Language Pathology Guidance for Tracheostomy During the COVID-19 Pandemic: An International Multidisciplinary Perspective. Am J Speech Lang Pathol. 2020 Aug 4;29(3):1320-1334. doi: 10.1044/2020_AJSLP-20-00089. Epub 2020 Jun 11.
- Results publication: PubMed 28979454McGrath B, Lynch J, Wilson M, Nicholson L, Wallace S. Above cuff vocalisation: A novel technique for communication in the ventilator-dependent tracheostomy patient. J Intensive Care Soc. 2016 Feb;17(1):19-26. doi: 10.1177/1751143715607549. Epub 2015 Oct 5.
- UK National Tracheostomy Safety Project webpage and video demonstrating the problem and current solutionLink provided by the sponsor.
- Individual participant dataSharing planned: No. The project will generate confidential patient data and commercially sensitive IP data. Summaries of these data will be shared publicly.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype medical device (SEA CtV) in people with Tracheostomy, run by Manchester University NHS Foundation Trust at 1 site 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 7 inclusion and 6 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 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Effectiveness of vocalisation (Patient-reported voice VAS) (time frame: Daily for up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647786, which also lists 3 linked publications.
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 20 Jan 2025.