Clinical trial NCT03008174: Early Speech With One-Way Speaking Valve in Tracheostomy Patients
Official title: Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Speech
Aphonia
Keywords: tracheostomy
quality of life
speaking valve
speech
mechanically ventilated patients
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with tracheostomy who are on and off of mechanical ventilation initially lose the ability to speak, and the use of one-way speaking valves (OWSV) is one method of restoring speech in these patients. Patients with tracheostomy who experience loss of speech report frustration and feelings of confinement from patients' communication impairment, therefore investigators would like to restore speech in these patients as soon as it is safe to do so. However, there is currently little known in the literature about the timing of the use of OWSV in patients with tracheostomy. Therefore, the investigators propose a pre-test post-test clinical trial pilot study to investigate the safety of early use of OWSV in patients undergoing a percutaneous tracheostomy. Study aims are to identify patients who would benefit from the early use of OWSV and to determine the effects of early use of OWSV on speech and clinical outcomes. To achieve these aims, patients who undergo percutaneous tracheostomy will be screened, and patients meeting screening criteria will be randomized into intervention and control groups. The intervention group will receive early speech-language pathology (SLP) evaluation and OWSV trial at 12-24 hours following tracheostomy procedure, and the control group will receive standard SLP evaluation and OWSV trial at 48-60 hours following tracheostomy procedure. Intervention and control groups will been compared on speech and clinical outcomes measures from pre-test at 12-24 hours following tracheostomy and post-test at 48-60 hours following tracheostomy and characteristics of patients who successfully tolerate early OWSV use will be identified.


Eligibility criteria: Inclusion Criteria:

* Patient who received a percutaneous tracheostomy
* Glasgow Coma Scale score ≥9
* Confusion Assessment Method -ICU (CAM-ICU): negative
* Richmond Agitation Sedation Scale (RASS): -1 to +1
* Able to understand English

Exclusion Criteria:

* Open tracheostomy
* Laryngectomy
* Presently using OWSV or capped trach
* Foam-filled cuffed tracheostomy tube
* Presence of known severe airway obstruction
* Presence of post-operative bleeding requiring transfusion or packing
* Presence of air-leak around the cuff resulting in respiratory decompensation

Primary outcomes:
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
timeFrame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
timeFrame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
measure: Speech Intelligibility as Assessed by Speech Intelligibility Test Score
timeFrame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
Secondary outcomes:
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
timeFrame: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
timeFrame: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
measure: Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores
timeFrame: Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
measure: Number of Participants With Bleeding
timeFrame: At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure
measure: Number of Participants With Bleeding
timeFrame: At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure
measure: Number of Participants With Bleeding
timeFrame: At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: At the time of discharge, up to 4 months
measure: Hospital Length of Stay
timeFrame: At the time of discharge, up to 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vinciya Pandian, PhD, MSN, ACNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.
citation: Mehta AB, Syeda SN, Bajpayee L, Cooke CR, Walkey AJ, Wiener RS. Trends in Tracheostomy for Mechanically Ventilated Patients in the United States, 1993-2012. Am J Respir Crit Care Med. 2015 Aug 15;192(4):446-54. doi: 10.1164/rccm.201502-0239OC.
citation: Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. doi: 10.1177/1049732307307334.
citation: Foster A. More than nothing: the lived experience of tracheostomy while acutely ill. Intensive Crit Care Nurs. 2010 Feb;26(1):33-43. doi: 10.1016/j.iccn.2009.09.004. Epub 2009 Nov 11.
citation: Freeman BD, Isabella K, Lin N, Buchman TG. A meta-analysis of prospective trials comparing percutaneous and surgical tracheostomy in critically ill patients. Chest. 2000 Nov;118(5):1412-8. doi: 10.1378/chest.118.5.1412.
citation: Pandian V, Thompson CB, Feller-Kopman DJ, Mirski MA. Development and validation of a quality-of-life questionnaire for mechanically ventilated ICU patients. Crit Care Med. 2015 Jan;43(1):142-8. doi: 10.1097/CCM.0000000000000552.
citation: Martin KA, Cole TDK, Percha CM, Asanuma N, Mattare K, Hager DN, Brenner MJ, Pandian V. Standard versus Accelerated Speaking Valve Placement after Percutaneous Tracheostomy: A Randomized Controlled Feasibility Study. Ann Am Thorac Soc. 2021 Oct;18(10):1693-1701. doi: 10.1513/AnnalsATS.202010-1282OC.