Aphonia, Respiratory Failure, Speech
Conditions
Keywords
tracheostomy, quality of life, speaking valve, speech, mechanically ventilated patients
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 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.
Interventions
OTHEREarly 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.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 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. |
| Number of Participants With Bleeding | At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure | Bleeding will be reported as present or absent. |
| Intensive Care Unit (ICU) Length of Stay | At the time of discharge, up to 4 months | ICU length of stay will be reported in days. |
| Hospital Length of Stay | At the time of discharge, up to 4 months | Hospital length of stay will be reported in days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 16.1 | 50.35 years STANDARD_DEVIATION 17.48 | 50.1 years STANDARD_DEVIATION 19.7 |
| Race/Ethnicity, Customized African American | 6 Participants | 9 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 3 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Middle Eastern | 0 Participants | 1 Participants | 1 Participants |
| Sequential Organ Failure Assessment (SOFA) Score | 6.0 score on a scale STANDARD_DEVIATION 1.63 | 5.8 score on a scale STANDARD_DEVIATION 1.88 | 5.6 score on a scale STANDARD_DEVIATION 2.17 |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Speech Intelligibility as Assessed by Speech Intelligibility Test Score
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 25.71 Percentage of intelligible words | Standard Deviation 33.35 |
| Control | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 0 Percentage of intelligible words | Standard Deviation 0 |
Primary
Speech Intelligibility as Assessed by Speech Intelligibility Test Score
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 13 Percentage of intelligible words | Standard Deviation 26.46 |
| Control | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 33.63 Percentage of intelligible words | Standard Deviation 33.12 |
Primary
Speech Intelligibility as Assessed by Speech Intelligibility Test Score
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
Population: Data for this outcome measure was only obtained from participants that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 74.54 Percentage of intelligible words | Standard Deviation 21.03 |
| Control | Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 35.97 Percentage of intelligible words | Standard Deviation 39.5 |
Secondary
Hospital Length of Stay
Hospital length of stay will be reported in days.
Time frame: At the time of discharge, up to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Hospital Length of Stay | 69.7 Days | Standard Deviation 33.86 |
| Control | Hospital Length of Stay | 75.6 Days | Standard Deviation 101.12 |
Secondary
Intensive Care Unit (ICU) Length of Stay
ICU length of stay will be reported in days.
Time frame: At the time of discharge, up to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Intensive Care Unit (ICU) Length of Stay | 51 Days | Standard Deviation 30.37 |
| Control | Intensive Care Unit (ICU) Length of Stay | 53.9 Days | Standard Deviation 51.46 |
Secondary
Number of Participants With Bleeding
Bleeding will be reported as present or absent.
Time frame: At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Bleeding | 0 Participants |
| Control | Number of Participants With Bleeding | 0 Participants |
Secondary
Number of Participants With Bleeding
Bleeding will be reported as present or absent.
Time frame: At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Bleeding | 0 Participants |
| Control | Number of Participants With Bleeding | 0 Participants |
Secondary
Number of Participants With Bleeding
Bleeding will be reported as present or absent.
Time frame: At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure
Population: Data for this outcome measure was only obtained from participants that completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Bleeding | 0 Participants |
| Control | Number of Participants With Bleeding | 0 Participants |
Secondary
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
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.
Time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 42.0 score on a scale | Standard Deviation 18 |
| Control | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 41.7 score on a scale | Standard Deviation 13.4 |
Secondary
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
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.
Time frame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
Population: Data for this outcome measure was only obtained from participants that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 55.0 score on a scale | Standard Deviation 22 |
| Control | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 47.1 score on a scale | Standard Deviation 16.2 |
Secondary
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
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.
Time frame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 53.1 score on a scale | Standard Deviation 24.8 |
| Control | Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores | 47.3 score on a scale | Standard Deviation 12.8 |