Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention | Experimental | Other: Early one-way speaking valve (OWSV) assessment | 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. |
| Control | No intervention | | 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. |
- 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.
+Outcome measures
Primary outcomes
- 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).
- Speech Intelligibility as Assessed by Speech Intelligibility Test Score [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).
- Speech Intelligibility as Assessed by Speech Intelligibility Test Score [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
- 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.
- Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores [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.
- Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores [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.
- 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.
- Number of Participants With Bleeding [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.
- Number of Participants With Bleeding [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.
- 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.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Posted results
Participant flow
| Milestone | Intervention | Control |
|---|
| Started | 10 | 10 |
| Completed | 7 | 6 |
| Not completed | 3 | 4 |
Outcome results
- Speech Intelligibility as Assessed by Speech Intelligibility Test Score (Primary), Mean, Percentage of intelligible words: Intervention 25.71 +/- 33.35; Control 0 +/- 0
- Speech Intelligibility as Assessed by Speech Intelligibility Test Score (Primary), Mean, Percentage of intelligible words: Intervention 13 +/- 26.46; Control 33.63 +/- 33.12
- Speech Intelligibility as Assessed by Speech Intelligibility Test Score (Primary), Mean, Percentage of intelligible words: Intervention 74.54 +/- 21.03; Control 35.97 +/- 39.5
- Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores (Secondary), Mean, score on a scale: Intervention 42.0 +/- 18.0; Control 41.7 +/- 13.4
- Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores (Secondary), Mean, score on a scale: Intervention 53.1 +/- 24.8; Control 47.3 +/- 12.8
- Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores (Secondary), Mean, score on a scale: Intervention 55.0 +/- 22.0; Control 47.1 +/- 16.2
- Number of Participants With Bleeding (Secondary), Count of participants, Participants: Intervention 0; Control 0
- Number of Participants With Bleeding (Secondary), Count of participants, Participants: Intervention 0; Control 0
- Number of Participants With Bleeding (Secondary), Count of participants, Participants: Intervention 0; Control 0
- Intensive Care Unit (ICU) Length of Stay (Secondary), Mean, Days: Intervention 51 +/- 30.37; Control 53.9 +/- 51.46
- Hospital Length of Stay (Secondary), Mean, Days: Intervention 69.7 +/- 33.86; Control 75.6 +/- 101.12
Adverse events
Time frame: 21 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Intervention | 0/10 (0.0%) | 0/10 (0.0%) | 0/10 (0.0%) |
| Control | 0/10 (0.0%) | 0/10 (0.0%) | 0/10 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| The Johns Hopkins Hospital | Baltimore, Maryland | United States | |
+Publications
- Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920. PMID 24891201
- 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. PMID 25955332
- 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. PMID 17968034
- 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. PMID 19910195
- 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. PMID 11083694
- 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. PMID 25072754
- Results publication: 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. PMID 33760713
+Study documents
+Investigators