Evaluate the Effect of a Talking Tracheostomy Tube on Quality of LifeBLUSANCT02018562

Evaluation of a Tracheostomy Tube That Enables Communication

A study testing Portex Blueline Ultra Suctionaid Tracheostomy Tube in people with Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
What is being tested?: Portex Blueline Ultra Suctionaid Tracheostomy Tube
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Feb 2015to 21 May 2017
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Mechanically ventilated via tracheostomy
Awake, alert, and attempting to communicate
Able to understand English

Who cannot join

Delirium
Fresh tracheostomy within 48 hours
Laryngectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

The Johns Hopkins Hospital
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Prospective Evaluation of a Tracheostomy Tube That Enables Communication in Ventilator Dependent Patients - A Pilot Study

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.

Conditions: Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Being tested: Portex Blueline Ultra Suctionaid Tracheostomy Tube
Keywords: Quality of Life, Talking Tracheostomy Tube, Speech, Mechanically ventilated patients
Medical subject headings: Speech

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Portex Blueline Ultra Suctionaid Tracheostomy TubeDevice

Study groups in NCT02018562
Study group	Role	What they receive
Intervention	Experimental	1. The talking tracheostomy trial 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. Receives: Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube
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

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: Baseline; 2 weeks post BLUSA

Secondary outcomes (5)

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.
Measured: 2 weeks
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.
Measured: 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.
Measured: 2 weeks
Overall Hospital Length of Stay
Measured in days
Measured: Time of discharge from the hospital (Approximately 6-8 months)
Intensive Care Unit (ICU) Length of Stay
Measured in days
Measured: Time of discharge from the ICU (Approximately 6-8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201521 May 2017

First posted23 Dec 2013 (estimated)
Study startFeb 2015
Primary completion21 Feb 2017
Study completion21 May 2017

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 (11)Papers the sponsor has linked to this study.
Other trials for Evaluate the Effect of a Talking Tracheostomy Tube on Quality of LifeStudies 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: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02018562
Sponsor's protocol ID: NA_00086689
Acronym: BLUSA
Status last verified: Sep 2024
First submitted: 3 Dec 2013
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 19531034
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.
PubMed 23583261
Hess DR. Facilitating speech in the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):519-25.
PubMed 15807915
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.
PubMed 21804129
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.
PubMed 18359351
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.
PubMed 18472265
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.
PubMed 20522796
Nomori H. Tracheostomy tube enabling speech during mechanical ventilation. Chest. 2004 Mar;125(3):1046-51. doi: 10.1378/chest.125.3.1046.
PubMed 15006967
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.
PubMed 21675700
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.
PubMed 22675004
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.
PubMed 31385620

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of a Tracheostomy Tube That Enables Communication in Ventilator Dependent Patients - A Pilot Study
ClinicalTrials.gov ID: NCT02018562
Acronym / sponsor ID: BLUSA / NA_00086689
Conditions: Evaluate the Effect of a Talking Tracheostomy Tube on Quality of Life
Keywords: Quality of Life, Talking Tracheostomy Tube, Speech, Mechanically ventilated patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: Feb 2015 (actual)
Primary completion: 21 Feb 2017 (actual)
Study completion: 21 May 2017 (actual)
First posted: 23 Dec 2013 (estimated)
Results: Posted 27 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study Hypothesis: Determine the impact of a talking tracheostomy tube on quality of life in patients requiring prolonged mechanical ventilation in the hospital.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: Portex Blueline Ultra Suctionaid Tracheostomy Tube1. The talking tracheostomy trial 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.
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

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Mechanically ventilated via tracheostomy
Awake, alert, and attempting to communicate
Able to understand English

Key exclusion criteria (3 listed)

Delirium
Fresh tracheostomy within 48 hours
Laryngectomy

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
Portex Blueline Ultra Suctionaid Tracheostomy Tube	Device	Intervention

Primary outcome

Change in Quality of Life
Time frame: 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).
Change in Quality of Life
Time frame: Baseline; 2 weeks post BLUSA
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.

5 secondary outcomes

Speech Intelligibility
Time frame: 2 weeks
Level of Independence With Talking Tracheostomy Tube
Time frame: 2 weeks
Patient Satisfaction With a Talking Tracheostomy Tube
Time frame: 2 weeks
Overall Hospital Length of Stay
Time frame: Time of discharge from the hospital (Approximately 6-8 months)
Intensive Care Unit (ICU) Length of Stay
Time frame: Time of discharge from the ICU (Approximately 6-8 months)

Results and safety

Results posted to the registry on 27 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	25	22
Control	25	25

Primary outcome: Change in Quality of Life

Time frame: Baseline; 2 weeks post BLUSA. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 25	Control n = 25
Baseline	44.65 (14.42)	42.78 (13.76)
2-weeks post BLUSA	50.24 (22.52)	49.41 (15.18)

Population analysed: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.

Primary outcome: Change in Quality of Life

Time frame: Baseline; 2 weeks post BLUSA. Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention n = 25	Control n = 25
Baseline	26.59 (16.81)	26.67 (16.72)
2-weeks post BLUSA	42.50 (17.69)	32.26 (24.90)

Population analysed: Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the time of consent to 2 weeks post intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Control	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19531034Batty 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.
Background: PubMed 23583261Frost 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.
Background: PubMed 15807915Hess DR. Facilitating speech in the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):519-25.
Background: PubMed 21804129Husain 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.
Results publication: PubMed 18359351Coffman 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.
Results publication: PubMed 18472265Hofhuis 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.
Results publication: PubMed 20522796Lacherade 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.
Results publication: PubMed 15006967Nomori H. Tracheostomy tube enabling speech during mechanical ventilation. Chest. 2004 Mar;125(3):1046-51. doi: 10.1378/chest.125.3.1046.
Results publication: PubMed 21675700Pandian 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.
Results publication: PubMed 22675004Pandian 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.
Derived from this study: PubMed 31385620Pandian 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.

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 19 Sep 2024. 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 27 Apr 2018). 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?

Change in Quality of Life (time frame: Baseline; 2 weeks post BLUSA). The study lists 2 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 NCT02018562, which also lists 11 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 19 Sep 2024.