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Safe and Effective Above Cuff Tracheostomy Ventilation

NCT04647786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 309

Last updated 2025-01-20

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Manchester Metropolitan University

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647786 on ClinicalTrials.gov