Early Speech With One-Way Speaking Valve in Tracheostomy Patients

NCT ID: NCT03008174

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-05
• Study Completion Date: 2019-12-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Early one-way speaking valve (OWSV) assessment

Intervention Type: 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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vinciya Pandian, PhD, MSN, ACNP

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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

Reference Type: BACKGROUND

PMID: 24891201 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25955332 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17968034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19910195 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11083694 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25072754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33760713 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00080981

Identifier Type: -

Identifier Source: org_study_id