Trial Outcomes & Findings for Evaluation of a Tracheostomy Tube That Enables Communication (NCT NCT02018562)
NCT ID: NCT02018562
Last Updated: 2024-09-19
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline; 2 weeks post BLUSA
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Discharged prior to study completion
|
1
|
0
|
Baseline Characteristics
Evaluation of a Tracheostomy Tube That Enables Communication
Baseline characteristics by cohort
| Measure |
Intervention
n=25 Participants
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
|
Control
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.72 years
STANDARD_DEVIATION 17.47 • n=5 Participants
|
57.92 years
STANDARD_DEVIATION 14.91 • n=7 Participants
|
54.32 years
STANDARD_DEVIATION 16.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; 2 weeks post BLUSAPopulation: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.
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).
Outcome measures
| Measure |
Intervention
n=25 Participants
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
|
Control
n=25 Participants
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
|
|---|---|---|
|
Change in Quality of Life
Baseline
|
44.65 units on a scale
Standard Deviation 14.42
|
42.78 units on a scale
Standard Deviation 13.76
|
|
Change in Quality of Life
2-weeks post BLUSA
|
50.24 units on a scale
Standard Deviation 22.52
|
49.41 units on a scale
Standard Deviation 15.18
|
PRIMARY outcome
Timeframe: Baseline; 2 weeks post BLUSAPopulation: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.
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.
Outcome measures
| Measure |
Intervention
n=25 Participants
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
|
Control
n=25 Participants
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
|
|---|---|---|
|
Change in Quality of Life
Baseline
|
26.59 units on a scale
Standard Deviation 16.81
|
26.67 units on a scale
Standard Deviation 16.72
|
|
Change in Quality of Life
2-weeks post BLUSA
|
42.50 units on a scale
Standard Deviation 17.69
|
32.26 units on a scale
Standard Deviation 24.90
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=18 Participants
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
|
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
|
|---|---|---|
|
Speech Intelligibility
|
53.1 percentage of intelligible sentences
Standard Deviation 25.8
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Intervention
n=22 Participants
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
|
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
|
|---|---|---|
|
Level of Independence With Talking Tracheostomy Tube
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction.
Outcome measures
| Measure |
Intervention
n=22 Participants
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
|
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
|
|---|---|---|
|
Patient Satisfaction With a Talking Tracheostomy Tube
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Time of discharge from the hospital (Approximately 6-8 months)Measured in days
Outcome measures
| Measure |
Intervention
n=25 Participants
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
|
Control
n=25 Participants
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
|
|---|---|---|
|
Overall Hospital Length of Stay
|
72.68 days
Standard Deviation 40.94
|
48.84 days
Standard Deviation 27.61
|
SECONDARY outcome
Timeframe: Time of discharge from the ICU (Approximately 6-8 months)Measured in days
Outcome measures
| Measure |
Intervention
n=25 Participants
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
|
Control
n=25 Participants
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
|
|---|---|---|
|
Intensive Care Unit (ICU) Length of Stay
|
58.12 days
Standard Deviation 36.56
|
39.04 days
Standard Deviation 23.71
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vinciya Pandian PhD, MSN, RN, ACNP-BC, FAAN
Johns Hopkins University
Phone: 4436553482
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place