Early Speech With One-Way Speaking Valve in Tracheostomy Patients

NCT03008174 | Completed Results DMC

• 1 other identifier: IRB00080981
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Speech; Aphonia

Keywords

tracheostomy; quality of life; speaking valve; speech; mechanically ventilated patients

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores

  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

  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

  Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)

• Number of Participants With Bleeding

  At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure

• Number of Participants With Bleeding

  At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure

Study Arms (2)

Intervention

EXPERIMENTAL

1. Early one-way speaking valve (OWSV) assessment by speech language pathologist (SLP) following 12-24 hours after percutaneous tracheostomy procedure. 2. Second OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. 3. 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

Control

NO INTERVENTION

1. Standard OWSV evaluation with SLP following 48-60 hours from initial percutaneous tracheostomy procedure. 2. 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.

Interventions

Early one-way speaking valve (OWSV) assessment OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (7)

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

  PMID: 24891201 BACKGROUND

• 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.

  PMID: 25955332 BACKGROUND

• 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.

  PMID: 17968034 BACKGROUND

• 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.

  PMID: 19910195 BACKGROUND

• 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.

  PMID: 11083694 BACKGROUND

• 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.

  PMID: 25072754 BACKGROUND

• 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.

  PMID: 33760713 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Speech; Aphonia

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Verbal Behavior; Communication; Behavior; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Results Point of Contact

• Title: Vinciya Pandian
• Organization: Johns Hopkins University

vpandia1@jhu.edu

4436553482

Study Officials

• Vinciya Pandian, PhD, MSN, ACNP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: January 2, 2017
• Study Start: February 5, 2016
• Primary Completion: November 28, 2019
• Study Completion: December 5, 2019
• Last Updated: January 23, 2020
• Results First Posted: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)