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Verbal communication is vital to critically ill mechanically ventilated patient's quality of life (Hess, 2005). Patients who have a tracheostomy tube may be able to communicate using a speaking valve, however, some patients may not be able to tolerate cuff deflation for use of speaking valve. There are talking tracheostomy tubes that do not require cuff deflation to facilitate speech in this population. Unfortunately, not all candidates are offered these options due to lack of awareness. Recently, at our institution, there has been an increase in the use of these tubes to facilitate speech. One of the talking tracheotomy tubes that has proven to be effective is the Portex Blueline Ultra Suctionaid (BLUSA).
In 2010, we conducted a retrospective review of 4 cases and found that BLUSA tracheostomy helped facilitate communication in this unique population (IRB #: NA_00041547). We would now like to formally conduct a prospective pilot study to evaluate the feasibility of measuring outcomes of patients with a BLUSA using a pretest-posttest research design.
Communication empowers patients and allows healthcare staff to obtain a more accurate assessment of patients' condition and tailor care accordingly. Identifying the predictors of speech intelligibility and the impact of BLUSA on quality of life will promote communication between patients and healthcare providers.
Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in patients requiring prolonged mechanical ventilation in the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
i. SLP will also assess the duration of successful speech during each session ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility. iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session. |
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| Control | No Intervention | This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portex Blueline Ultra Suctionaid Tracheostomy Tube | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Quality of Life in Mechanically Ventilated Patients Questionnaire (QOL-MV) was used to measure quality of life. It is a 12-item scale with each items 0 - 10 and total score ranges from 0 - 120. Lower scores refers to lower quality of life and Higher scores refer to higher level quality of life. To be assessed at baseline and 2 weeks post Portex Blueline Ultra Suctionaid (BLUSA). | Baseline; 2 weeks post BLUSA |
| Change in Quality of Life | Voice-Related Quality of Life (V-RQOL). It is a 10-item scale with each items 2 - 10 and total score ranges from 20 - 100. Lower scores refers to higher quality of life and Higher scores refer to lower level quality of life. | Baseline; 2 weeks post BLUSA |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility | The Speech Intelligibility Test has 11 randomly computer generated sentences that patients are asked to read aloud. They are recorded and judged by an unfamiliar listener at a later time. Scores range from 0 - 100 with higher scores indicating greater level of speech intelligibility. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19531034 | Background | Batty S. Communication, swallowing and feeding in the intensive care unit patient. Nurs Crit Care. 2009 Jul-Aug;14(4):175-9. doi: 10.1111/j.1478-5153.2009.00332.x. | |
| 23583261 | Background | Frost SA, Azeem A, Alexandrou E, Tam V, Murphy JK, Hunt L, O'Regan W, Hillman KM. Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis. Aust Crit Care. 2013 Nov;26(4):180-8. doi: 10.1016/j.aucc.2013.03.003. Epub 2013 Apr 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention |
i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility. iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session. Portex Blueline Ultra Suctionaid Tracheostomy Tube |
| FG001 | Control | This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention |
i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility. iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session. Portex Blueline Ultra Suctionaid Tracheostomy Tube |
| 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 | Change in Quality of Life | Quality of Life in Mechanically Ventilated Patients Questionnaire (QOL-MV) was used to measure quality of life. It is a 12-item scale with each items 0 - 10 and total score ranges from 0 - 120. Lower scores refers to lower quality of life and Higher scores refer to higher level quality of life. To be assessed at baseline and 2 weeks post Portex Blueline Ultra Suctionaid (BLUSA). | Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 2 weeks post BLUSA |
|
Adverse event data was collected from the time of consent to 2 weeks post intervention.
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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 |
i. SLP will also assess the duration of successful speech during each session. ii. Sentence intelligibility will also be assessed during the 3rd session. This session will be audio-taped and reviewed by a second rater for sentence intelligibility. iii. SLP will determine the level of independence with talking tracheostomy during the 3rd session. Portex Blueline Ultra Suctionaid Tracheostomy Tube |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vinciya Pandian PhD, MSN, RN, ACNP-BC, FAAN | 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 | Dec 19, 2013 | Feb 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013060 | Speech |
| ID | Term |
|---|---|
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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Unable to mask because patients and care providers were able to visualize the type of tracheostomy tub that was used.
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| Level of Independence With Talking Tracheostomy Tube |
Participants were asked how independently they thought they could use the tracheostomy tube. Will report the number of participants who indicated some level of independence. |
| 2 weeks |
| Patient Satisfaction With a Talking Tracheostomy Tube | Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction. | 2 weeks |
| Overall Hospital Length of Stay | Measured in days | Time of discharge from the hospital (Approximately 6-8 months) |
| Intensive Care Unit (ICU) Length of Stay | Measured in days | Time of discharge from the ICU (Approximately 6-8 months) |
| 15807915 | Background | Hess DR. Facilitating speech in the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):519-25. |
| 21804129 | Background | Husain T, Gatward JJ, Harris RD. Use of subglottic suction port to enable verbal communication in ventilator-dependent patients. Am J Respir Crit Care Med. 2011 Aug 1;184(3):384. doi: 10.1164/ajrccm.184.3.384. No abstract available. |
| 18359351 | Result | Coffman HM, Rees CJ, Sievers AE, Belafsky PC. Proximal suction tracheotomy tube reduces aspiration volume. Otolaryngol Head Neck Surg. 2008 Apr;138(4):441-5. doi: 10.1016/j.otohns.2007.11.013. |
| 18472265 | Result | Hofhuis JG, Spronk PE, van Stel HF, Schrijvers AJ, Rommes JH, Bakker J. Experiences of critically ill patients in the ICU. Intensive Crit Care Nurs. 2008 Oct;24(5):300-13. doi: 10.1016/j.iccn.2008.03.004. Epub 2008 May 9. |
| 20522796 | Result | Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3. |
| 15006967 | Result | Nomori H. Tracheostomy tube enabling speech during mechanical ventilation. Chest. 2004 Mar;125(3):1046-51. doi: 10.1378/chest.125.3.1046. |
| 21675700 | Result | Pandian V, Maragos C, Turner L, Mirski M, Bhatti N, Joyner K. Model for best practice: nurse practitioner facilitated percutaneous tracheostomy service. ORL Head Neck Nurs. 2011 Spring;29(2):8-15. |
| 22675004 | Result | Pandian V, Miller CR, Mirski MA, Schiavi AJ, Morad AH, Vaswani RS, Kalmar CL, Feller-Kopman DJ, Haut ER, Yarmus LB, Bhatti NI. Multidisciplinary team approach in the management of tracheostomy patients. Otolaryngol Head Neck Surg. 2012 Oct;147(4):684-91. doi: 10.1177/0194599812449995. Epub 2012 Jun 5. |
| 31385620 | Derived | Pandian V, Cole T, Kilonsky D, Holden K, Feller-Kopman DJ, Brower R, Mirski M. Voice-Related Quality of Life Increases With a Talking Tracheostomy Tube: A Randomized Controlled Trial. Laryngoscope. 2020 May;130(5):1249-1255. doi: 10.1002/lary.28211. Epub 2019 Aug 6. |
| BG001 | Control | This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Control | This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed |
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| Primary | Change in Quality of Life | Voice-Related Quality of Life (V-RQOL). It is a 10-item scale with each items 2 - 10 and total score ranges from 20 - 100. Lower scores refers to higher quality of life and Higher scores refer to lower level quality of life. | Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline; 2 weeks post BLUSA |
|
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| Secondary | Speech Intelligibility | The Speech Intelligibility Test has 11 randomly computer generated sentences that patients are asked to read aloud. They are recorded and judged by an unfamiliar listener at a later time. Scores range from 0 - 100 with higher scores indicating greater level of speech intelligibility. | Only 18 participants in the intervention group were assessed because only 18 of them were able to read the sentences. No data was collected from any participants in the control group for this outcome measure. | Posted | Mean | Standard Deviation | percentage of intelligible sentences | 2 weeks |
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| Secondary | Level of Independence With Talking Tracheostomy Tube | Participants were asked how independently they thought they could use the tracheostomy tube. Will report the number of participants who indicated some level of independence. | This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm. | Posted | Count of Participants | Participants | 2 weeks |
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| Secondary | Patient Satisfaction With a Talking Tracheostomy Tube | Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction. | This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm. | Posted | Count of Participants | Participants | 2 weeks |
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| Secondary | Overall Hospital Length of Stay | Measured in days | Posted | Mean | Standard Deviation | days | Time of discharge from the hospital (Approximately 6-8 months) |
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| Secondary | Intensive Care Unit (ICU) Length of Stay | Measured in days | Posted | Mean | Standard Deviation | days | Time of discharge from the ICU (Approximately 6-8 months) |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control | This group will also receive talking tracheostomy tube trial as standard of care but a week later after the pre and post assessments have been completed | 0 | 25 | 0 | 25 | 0 | 25 |
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| 2-weeks post BLUSA |
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