Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Conditions
Keywords
Quality of Life, Talking Tracheostomy Tube, Speech, Mechanically ventilated patients
Brief summary
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.
Interventions
DEVICEPortex Blueline Ultra Suctionaid Tracheostomy Tube
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Unable to mask because patients and care providers were able to visualize the type of tracheostomy tub that was used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Mechanically ventilated via tracheostomy * Awake, alert, and attempting to communicate * Able to understand English
Exclusion criteria
* Delirium * Fresh tracheostomy within 48 hours * Laryngectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline; 2 weeks post BLUSA | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility | 2 weeks | 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. |
| Level of Independence With Talking Tracheostomy Tube | 2 weeks | 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. |
| Patient Satisfaction With a Talking Tracheostomy Tube | 2 weeks | Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction. |
| Overall Hospital Length of Stay | Time of discharge from the hospital (Approximately 6-8 months) | Measured in days |
| Intensive Care Unit (ICU) Length of Stay | Time of discharge from the ICU (Approximately 6-8 months) | Measured in days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 1. This involves placement of a talking tracheostomy tube (Portex Blueline Ultra Suctionaid Tracheostomy Tube) by respiratory therapist after obtaining an order from an authorized prescriber (Physician or Nurse Practitioner). The Speech-Language Pathologist (SLP) sets up the tracheostomy tube for speech and then determines the optimal air flow required for voicing. This amount of air flow is communicated to the ICU staff for further use.
2. We will ensure that the SLP meets with the patient for a minimum of 3 sessions within a week to optimize the use of a talking tracheostomy tube.
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 | 25 |
| 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 | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged prior to study completion | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 50.72 years STANDARD_DEVIATION 17.47 | 54.32 years STANDARD_DEVIATION 16.48 | 57.92 years STANDARD_DEVIATION 14.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 50 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 18 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 15 Participants | 25 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 25 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
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).
Time frame: Baseline; 2 weeks post BLUSA
Population: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Quality of Life | Baseline | 44.65 units on a scale | Standard Deviation 14.42 |
| Intervention | Change in Quality of Life | 2-weeks post BLUSA | 50.24 units on a scale | Standard Deviation 22.52 |
| Control | Change in Quality of Life | Baseline | 42.78 units on a scale | Standard Deviation 13.76 |
| Control | Change in Quality of Life | 2-weeks post BLUSA | 49.41 units on a scale | Standard Deviation 15.18 |
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.
Time frame: Baseline; 2 weeks post BLUSA
Population: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change in Quality of Life | Baseline | 26.59 units on a scale | Standard Deviation 16.81 |
| Intervention | Change in Quality of Life | 2-weeks post BLUSA | 42.50 units on a scale | Standard Deviation 17.69 |
| Control | Change in Quality of Life | Baseline | 26.67 units on a scale | Standard Deviation 16.72 |
| Control | Change in Quality of Life | 2-weeks post BLUSA | 32.26 units on a scale | Standard Deviation 24.9 |
Secondary
Intensive Care Unit (ICU) Length of Stay
Measured in days
Time frame: Time of discharge from the ICU (Approximately 6-8 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Intensive Care Unit (ICU) Length of Stay | 58.12 days | Standard Deviation 36.56 |
| Control | Intensive Care Unit (ICU) Length of Stay | 39.04 days | Standard Deviation 23.71 |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Level of Independence With Talking Tracheostomy Tube | 16 Participants |
Secondary
Overall Hospital Length of Stay
Measured in days
Time frame: Time of discharge from the hospital (Approximately 6-8 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Overall Hospital Length of Stay | 72.68 days | Standard Deviation 40.94 |
| Control | Overall Hospital Length of Stay | 48.84 days | Standard Deviation 27.61 |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Patient Satisfaction With a Talking Tracheostomy Tube | 9 Participants |
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.
Time frame: 2 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Speech Intelligibility | 53.1 percentage of intelligible sentences | Standard Deviation 25.8 |