Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008174
• Other study ID #: IRB00080981
• Status: Completed
• Phase: N/A
• Start date: February 5, 2016
• Est. completion date: December 5, 2019

Study information

• Verified date: January 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 5, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphonia
• Respiratory Failure
• Respiratory Insufficiency
• Speech

Intervention

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.

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Carroll SM. Silent, slow lifeworld: the communication experience of nonvocal ventilated patients. Qual Health Res. 2007 Nov;17(9):1165-77. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Length of Stay	Hospital length of stay will be reported in days.	At the time of discharge, up to 4 months