Trial Outcomes & Findings for Early Speech With One-Way Speaking Valve in Tracheostomy Patients (NCT NCT03008174)

NCT ID: NCT03008174

Last Updated: 2020-01-23

Results Overview

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)
• Results posted on: 2020-01-23

Participant Flow

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	10	10
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Speech With One-Way Speaking Valve in Tracheostomy Patients

Baseline characteristics by cohort

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.	Total n=20 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 19.7 • n=5 Participants	50.6 years STANDARD_DEVIATION 16.1 • n=7 Participants	50.35 years STANDARD_DEVIATION 17.48 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sequential Organ Failure Assessment (SOFA) Score	5.6 score on a scale STANDARD_DEVIATION 2.17 • n=5 Participants	6.0 score on a scale STANDARD_DEVIATION 1.63 • n=7 Participants	5.8 score on a scale STANDARD_DEVIATION 1.88 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	25.71 Percentage of intelligible words Standard Deviation 33.35	0 Percentage of intelligible words Standard Deviation 0

PRIMARY outcome

Timeframe: Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	13 Percentage of intelligible words Standard Deviation 26.46	33.63 Percentage of intelligible words Standard Deviation 33.12

PRIMARY outcome

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

Population: Data for this outcome measure was only obtained from participants that completed the study.

Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).

Outcome measures

Measure	Intervention n=7 Participants 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. 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.	Control n=6 Participants 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.
Speech Intelligibility as Assessed by Speech Intelligibility Test Score	74.54 Percentage of intelligible words Standard Deviation 21.03	35.97 Percentage of intelligible words Standard Deviation 39.5

SECONDARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	42.0 score on a scale Standard Deviation 18.0	41.7 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	53.1 score on a scale Standard Deviation 24.8	47.3 score on a scale Standard Deviation 12.8

SECONDARY outcome

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

Population: Data for this outcome measure was only obtained from participants that completed the study.

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.

Outcome measures

Measure	Intervention n=7 Participants 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. 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.	Control n=6 Participants 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.
Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores	55.0 score on a scale Standard Deviation 22.0	47.1 score on a scale Standard Deviation 16.2

SECONDARY outcome

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

Bleeding will be reported as present or absent.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Number of Participants With Bleeding	0 Participants	0 Participants

SECONDARY outcome

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

Bleeding will be reported as present or absent.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Number of Participants With Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure

Population: Data for this outcome measure was only obtained from participants that completed the study.

Bleeding will be reported as present or absent.

Outcome measures

Measure	Intervention n=7 Participants 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. 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.	Control n=6 Participants 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.
Number of Participants With Bleeding	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At the time of discharge, up to 4 months

ICU length of stay will be reported in days.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Intensive Care Unit (ICU) Length of Stay	51 Days Standard Deviation 30.37	53.9 Days Standard Deviation 51.46

SECONDARY outcome

Timeframe: At the time of discharge, up to 4 months

Hospital length of stay will be reported in days.

Outcome measures

Measure	Intervention n=10 Participants 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. 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.	Control n=10 Participants 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.
Hospital Length of Stay	69.7 Days Standard Deviation 33.86	75.6 Days Standard Deviation 101.12

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vinciya Pandian

Johns Hopkins University

Phone: 4436553482

Email: vpandia1@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place