Evaluation of a Tracheostomy Tube That Enables Communication
NCT ID: NCT02018562
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-02-28
2017-05-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
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.
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
No interventions assigned to this group
Interventions
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Portex Blueline Ultra Suctionaid Tracheostomy Tube
Eligibility Criteria
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Inclusion Criteria
* Awake, alert, and attempting to communicate
* Able to understand English
Exclusion Criteria
* Fresh tracheostomy within 48 hours
* Laryngectomy
18 Years
100 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Locations
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The Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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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.
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.
Hess DR. Facilitating speech in the patient with a tracheostomy. Respir Care. 2005 Apr;50(4):519-25.
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.
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.
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.
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.
Nomori H. Tracheostomy tube enabling speech during mechanical ventilation. Chest. 2004 Mar;125(3):1046-51. doi: 10.1378/chest.125.3.1046.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NA_00086689
Identifier Type: -
Identifier Source: org_study_id
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