Early Speech With One-Way Speaking Valve in Tracheostomy Patients

ID: NCT03008174
Status: Recruiting
Phase: N/A
Start Date: February 05, 2016
First Submitted: November 28, 2016
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Johns Hopkins University
Location: United States
Conditions: Respiratory Failure, Speech, Aphonia
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Study Description

Brief Summary

Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from their communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.

Detailed Description

Condition or disease Intervention/treatment Phase

Aphonia

Respiratory Failure

Speech

Other: Early one-way speaking valve (OWSV) assessment
Other Names
N/A

Tracking Information

First Submitted DateNovember 28, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateFebruary 05, 2016
Anticipated Completion DateNovember 28, 2019
Actual Primary Completion DateNovember 28, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Speech Intelligibility [Time Frame: up to 24 hours after percutaneous tracheostomy procedure]

    Speech outcomes as assessed by Speech Intelligibility Test Scores. Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

  • Speech Intelligibility [Time Frame: up to 60 hours after percutaneous tracheostomy procedure]

    Speech outcomes as assessed by Speech Intelligibility Test Scores. Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

  • Speech Intelligibility [Time Frame: up to 21 days after percutaneous tracheostomy procedure]

    Speech outcomes as assessed by Speech Intelligibility Test Scores. Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores [Time Frame: up to 24 hours after percutaneous tracheostomy procedure]

    Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100.

  • Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores [Time Frame: up to 60 hours after percutaneous tracheostomy procedure]

    Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100.

  • Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores [Time Frame: up to 21 days after percutaneous tracheostomy procedure]

    Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100.

  • Bleeding [Time Frame: at the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure]

    Bleeding will be reported as present or absent.

  • Bleeding [Time Frame: at the time of use of speaking valve up to 60hours after percutaneous tracheostomy procedure]

    Bleeding will be reported as present or absent.

  • Bleeding [Time Frame: at the time of use of speaking valve up to 21 days after percutaneous tracheostomy procedure]

    Bleeding will be reported as present or absent.

  • ICU length of stay [Time Frame: at the time of discharge, up to four months]

    ICU length of stay will be reported in days.

  • Hospital length of stay [Time Frame: at the time of discharge, up to four months]

    Hospital length of stay will be reported in days.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEarly Speech With One-Way Speaking Valve in Tracheostomy Patients
Official TitleEarly Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study
Brief Summary

Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from their communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
20
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Aphonia
Respiratory Failure
Speech
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Early one-way speaking valve (OWSV) assessment

The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.

Other Names
Study Groups/Cohorts
Intervention
Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.

Control
Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.

Study Arms
Experimental Intervention
Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.
Other : Early one-way speaking valve (OWSV) assessment
The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.

Arm Intervention/Treatment
Experimental Intervention
Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.
Other : Early one-way speaking valve (OWSV) assessment

Recruitment Information

Recruitment Status:Recruiting
Enrollment20
Completion DateNovember 28, 2019
Eligibility Criteria: Inclusion Criteria:
- Patient who received a percutaneous tracheostomy
- Glasgow Coma Scale score ≥11
- Confusion Assessment Method -ICU (CAM-ICU): negative
- Richmond Agitation Sedation Scale (RASS): -1 to +1
- Able to understand English

Exclusion Criteria:
- Open tracheostomy
- Laryngectomy
- Presently using OWSV or capped trach
- Foam-filled cuffed tracheostomy tube
- Presence of known severe airway obstruction
- Presence of post-operative bleeding requiring transfusion or packing
- Presence of air-leak around the cuff resulting in respiratory decompensation
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03008174
Other Study ID Numbers
IRB00080981
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Johns Hopkins University
Collaborators
Not Available
Investigators
Not Available