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Completed

NCT Number: NCT03008174

Early Speech With One-Way Speaking Valve in Tracheostomy Patients

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 patients' 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who received a percutaneous tracheostomy
  • Glasgow Coma Scale score ≥9
  • 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

Treatment and study plan

Early one-way speaking valve (OWSV) assessment

Other

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.

Primary outcomes

  1. Speech Intelligibility as Assessed by Speech Intelligibility Test Score

    Time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

    Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

  2. Speech Intelligibility as Assessed by Speech Intelligibility Test Score

    Time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

    Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

  3. Speech Intelligibility as Assessed by Speech Intelligibility Test Score

    Time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

    Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Secondary outcomes

  1. Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores

    Time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

    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. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

  2. Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores

    Time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

    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. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

  3. Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores

    Time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

    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. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.

  4. Number of Participants With 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.

  5. Number of Participants With Bleeding

    Time frame: At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure

    Bleeding will be reported as present or absent.

  6. Number of Participants With Bleeding

    Time frame: At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure

    Bleeding will be reported as present or absent.

  7. Intensive Care Unit (ICU) Length of Stay

    Time frame: At the time of discharge, up to 4 months

    ICU length of stay will be reported in days.

  8. Hospital Length of Stay

    Time frame: At the time of discharge, up to 4 months

    Hospital length of stay will be reported in days.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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