Early Speech With One-Way Speaking Valve in Tracheostomy Patients

January 14, 2020 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention
  1. Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.
  2. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
  3. 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.
NO_INTERVENTION: Control
  1. Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.
  2. 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
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).
Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
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).
Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
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.
At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure
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.
At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure
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.
At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure
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.
At the time of discharge, up to 4 months
Hospital Length of Stay
Time Frame: At the time of discharge, up to 4 months
Hospital length of stay will be reported in days.
At the time of discharge, up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vinciya Pandian, PhD, MSN, ACNP, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00080981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will not be sharing data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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