Safe and Effective Above Cuff Tracheostomy Ventilation

NCT04647786 | Completed DMC

• 1 other identifier: B00990
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Tracheostomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Daily for up to 7 days

Secondary Outcomes (4)

• Voice rating

  Daily for up to 7 days

• Adverse events record

  Daily for up to 7 days

• Patient reported subjective tolerability

  Daily for up to 7 days

• Time to first oral intake

  Daily for up to 7 days

Study Arms (6)

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Manchester Metropolitan University: collaborator

Study Sites (1)

Manchester University NHS Foundation trust

Manchester, M23 9LT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30792764 BACKGROUND

• Zaga 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.

  PMID: 32525695 BACKGROUND

• McGrath 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.

  PMID: 28979454 BACKGROUND

Related Links

• UK National Tracheostomy Safety Project webpage and video demonstrating the problem and current solution

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 3 phases: 1. Safety testing in sequential patients 2. 2x2 factorial design 3. Simple unblinded RCT using finalised device vs standard care

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 1, 2020
• Study Start: July 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)