Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Early Speech With One-Way Speaking Valve in Tracheostomy Patients - Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Aphonia; Speech
• Intervention / Treatment: Other: Early one-way speaking valve (OWSV) assessment

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure.; Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.; Third OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between second and third sessions per standard of care.	Other: Early one-way speaking valve (OWSV) assessment; The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.
NO_INTERVENTION: Control; Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure.; Second OWSV evaluation with SLP following first tracheostomy tube change. Participants may receive additional SLP sessions between first and second sessions per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).	Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).	Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).	Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.	Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.	Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.	Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)
Number of Participants With Bleeding	Bleeding will be reported as present or absent.	At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure
Number of Participants With Bleeding	Bleeding will be reported as present or absent.	At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure
Number of Participants With Bleeding	Bleeding will be reported as present or absent.	At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure
Intensive Care Unit (ICU) Length of Stay	ICU length of stay will be reported in days.	At the time of discharge, up to 4 months
Hospital Length of Stay	Hospital length of stay will be reported in days.	At the time of discharge, up to 4 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Vinciya Pandian, PhD, MSN, ACNP, Johns Hopkins University

Publications and helpful links

General Publications

• Hess DR, Altobelli NP. Tracheostomy tubes. Respir Care. 2014 Jun;59(6):956-71; discussion 971-3. doi: 10.4187/respcare.02920.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 5, 2016
• Primary Completion (ACTUAL): November 28, 2019
• Study Completion (ACTUAL): December 5, 2019

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (ESTIMATE): January 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; speech; tracheostomy; mechanically ventilated patients; speaking valve
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Laryngeal Diseases; Voice Disorders; Respiratory Insufficiency; Aphonia
• Other Study ID Numbers: IRB00080981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will not be sharing data