Respiratory FailureNCT03008174
Early Speech With One-Way Speaking Valve in Tracheostomy Patients
A study testing Early one-way speaking valve (OWSV) assessment in people with Respiratory Failure and Speech, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Speech, Aphonia
- What is being tested?
- Early one-way speaking valve (OWSV) assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2016to 5 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
Official title: 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.
- Conditions
- Respiratory Failure, Speech, Aphonia
- Being tested
- Early one-way speaking valve (OWSV) assessment
- Keywords
- tracheostomy, quality of life, speaking valve, speech, mechanically ventilated patients
- Medical subject headings
- Respiratory Insufficiency, Speech, Aphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early one-way speaking valve (OWSV) assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Early one-way speaking valve (OWSV) assessment |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility as Assessed by Speech Intelligibility Test Score
Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).
Measured: 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).
Measured: 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).
Measured: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
Secondary outcomes (8)
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of discharge, up to 4 months
Hospital Length of Stay
Hospital length of stay will be reported in days.
Measured: At the time of discharge, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start5 Feb 2016
- Primary completion28 Nov 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinciya Pandian, PhD, MSN, ACNP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008174
- Sponsor's protocol ID
- IRB00080981
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2016
- Last updated
- 23 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Will not be sharing data
Publications
Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.
PubMed 24891201Mehta 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.
PubMed 25955332Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334.
PubMed 17968034Foster 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.
PubMed 19910195Freeman 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.
PubMed 11083694Pandian 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.
PubMed 25072754Martin 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.
PubMed 33760713
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study
- ClinicalTrials.gov ID
- NCT03008174
- Acronym / sponsor ID
- IRB00080981
- Conditions
- Respiratory Failure, Speech, Aphonia
- Keywords
- tracheostomy, quality of life, speaking valve, speech, mechanically ventilated patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 Feb 2016 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Posted 23 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Early one-way speaking valve (OWSV) assessment1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Open tracheostomy
- Laryngectomy
- Presently using OWSV or capped trach
- Foam-filled cuffed tracheostomy tube
- Presence of known severe airway obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early one-way speaking valve (OWSV) assessmentThe 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. | Other | Intervention |
Primary outcome
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).
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).
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).
8 secondary outcomes
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
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
Time frame: 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
Number of Participants With Bleeding
Time frame: 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
Intensive Care Unit (ICU) Length of Stay
Time frame: At the time of discharge, up to 4 months
Hospital Length of Stay
Time frame: At the time of discharge, up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24891201Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.
- Background: PubMed 25955332Mehta 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.
- Background: PubMed 17968034Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334.
- Background: PubMed 19910195Foster 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.
- Background: PubMed 11083694Freeman 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.
- Background: PubMed 25072754Pandian 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.
- Derived from this study: PubMed 33760713Martin 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.
- Individual participant dataSharing planned: No. Will not be sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinciya Pandian, PhD, MSN, ACNP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early one-way speaking valve (OWSV) assessment in people with Respiratory Failure and Speech, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Intelligibility as Assessed by Speech Intelligibility Test Score (time frame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008174, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.