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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
|
| Control | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility as Assessed by Speech Intelligibility Test Score | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vinciya Pandian, PhD, MSN, ACNP | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24891201 | Background | Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920. | |
| 25955332 | Background | Mehta AB, Syeda SN, Bajpayee L, Cooke CR, Walkey AJ, Wiener RS. Trends in Tracheostomy for Mechanically Ventilated Patients in the United States, 1993-2012. Am J Respir Crit Care Med. 2015 Aug 15;192(4):446-54. doi: 10.1164/rccm.201502-0239OC. |
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Will not be sharing data
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention |
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. |
| FG001 | Control |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention |
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Percentage of intelligible words | Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period) |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention |
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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinciya Pandian | Johns Hopkins University | 4436553482 | vpandia1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2018 | Dec 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D013060 | Speech |
| D001044 | Aphonia |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D014705 | Verbal Behavior |
| D003142 | Communication |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| 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. | 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 | 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 | 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 | 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 | 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 | ICU length of stay will be reported in days. | At the time of discharge, up to 4 months |
| Hospital Length of Stay | Hospital length of stay will be reported in days. | At the time of discharge, up to 4 months |
| 17968034 | Background | Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334. |
| 19910195 | Background | Foster A. More than nothing: the lived experience of tracheostomy while acutely ill. Intensive Crit Care Nurs. 2010 Feb;26(1):33-43. doi: 10.1016/j.iccn.2009.09.004. Epub 2009 Nov 11. |
| 11083694 | Background | Freeman BD, Isabella K, Lin N, Buchman TG. A meta-analysis of prospective trials comparing percutaneous and surgical tracheostomy in critically ill patients. Chest. 2000 Nov;118(5):1412-8. doi: 10.1378/chest.118.5.1412. |
| 25072754 | Background | Pandian V, Thompson CB, Feller-Kopman DJ, Mirski MA. Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med. 2015 Jan;43(1):142-8. doi: 10.1097/CCM.0000000000000552. |
| 33760713 | Derived | Martin KA, Cole TDK, Percha CM, Asanuma N, Mattare K, Hager DN, Brenner MJ, Pandian V. Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study. Ann Am Thorac Soc. 2021 Oct;18(10):1693-1701. doi: 10.1513/AnnalsATS.202010-1282OC. |
| BG001 | Control |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sequential Organ Failure Assessment (SOFA) Score | The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. SOFA scores will be reported on a scale of 0 - 24. The lower the score, the patient is not sick and the higher the score, the patient is sicker. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Control |
|
|
|
| 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). | Posted | Mean | Standard Deviation | Percentage of intelligible words | Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period) |
|
|
|
| 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). | Data for this outcome measure was only obtained from participants that completed the study. | Posted | Mean | Standard Deviation | Percentage of intelligible words | Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period) |
|
|
|
| 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. | Data for this outcome measure was only obtained from participants that completed the study. | Posted | Mean | Standard Deviation | score on a scale | Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period) |
|
|
|
| Secondary | Number of Participants With Bleeding | Bleeding will be reported as present or absent. | Posted | Count of Participants | Participants | At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure |
|
|
|
| Secondary | Number of Participants With Bleeding | Bleeding will be reported as present or absent. | Posted | Count of Participants | Participants | At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure |
|
|
|
| Secondary | Number of Participants With Bleeding | Bleeding will be reported as present or absent. | Data for this outcome measure was only obtained from participants that completed the study. | Posted | Count of Participants | Participants | At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure |
|
|
|
| Secondary | Intensive Care Unit (ICU) Length of Stay | ICU length of stay will be reported in days. | Posted | Mean | Standard Deviation | Days | At the time of discharge, up to 4 months |
|
|
|
| Secondary | Hospital Length of Stay | Hospital length of stay will be reported in days. | Posted | Mean | Standard Deviation | Days | At the time of discharge, up to 4 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Control |
| 0 | 10 | 0 | 10 | 0 | 10 |
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| D001519 |
| Behavior |
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |