Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting

Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting

Limited research has been done to assess the safety of PMV use during sleep. One prospective study completed by Diez-Gross, et al in 2007 looked at 10 male subjects recorded on two consecutive nights, one night with PMV on and one night with PMV off. All recordings took place in a monitored setting. The variables studied included O2 saturation, apnea index, apnea - hypopnea index, and nursing reports. Conclusion was PMV use for one night in seriously ill tracheostomy patients was not associated with respiratory distress or cardiac issues.

Study Overview

• Status: Completed
• Conditions: Tracheostomy
• Intervention / Treatment: Device: Tracheostomy Plug; Device: Passy Muir Valve

Detailed Description

Currently, the PMV has only been approved by the FDA for daytime use. As such, it is encouraged to remove speaking valves at night. However, there is minimal evidence indicating that the use of speaking valves during nighttime poses a significant risk. Studies focusing on the safety of the PMV for nocturnal use reported no significant effects on patients' well-being, including no significant oxygen desaturations or major cardiopulmonary events. This was shown in pediatric patients and adult patients admitted to an ICU. While promising, these findings are still limited, and additional evidence is needed to demonstrate the safety of nocturnal PMV use before larger studies can be conducted.

It was anecdotally witnessed that patients frequently sleep during the day with the PMV in place, suffering no recourse to adverse events. The primary objective of this study was to determine if nocturnal PMV use can be considered safe within the long-term acute care hospital setting and its impact on sleep quality

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Wallingford, Connecticut, United States, 06492
      • Gaylord Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient has evidence of respiratory insufficiency requiring a tracheostomy tube without current need for assisted ventilation.
2. Patient will be continuously monitored with telemetry.
3. Patient satisfies criteria for the decannulation protocol and agrees to use the Passy Muir Valve during sleep.
4. Patient is able to follow directions following speech/language/cognitive evaluation or screening completed by the Speech-Language Pathologist and physician assessment.
5. Patient is at least 18 years old.
6. An informed consent is signed by patient or Power of Attorney (POA).
7. Patient is able to tolerate the PMV during the day for a minimum of 6 continuous hours
8. Patient has a maximum size #6 Shiley cuffless tracheostomy tube or equivalent.

Exclusion Criteria:

1. Patient identified at time of admission as requiring invasive long-term assisted ventilation.
2. Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube.
3. Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency).
4. Patient or POA failed to sign consent.
5. Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist.
6. Patient unable to meet criteria for decannulation protocol or has failed decannulation protocol within last two weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tracheostomy Plug; Patients receive tracheostomy plug during night 2.	Device: Tracheostomy Plug
Experimental: Passy-Muir Valve; Patients receive Passy-Muir Valve during night 1.	Device: Passy Muir Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Measures the number of contractions of the heart per minute (bpm). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Systolic Blood Pressure	Measures the pressure in your arteries when your heart beats (mmHg). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Diastolic Blood Pressure	Measures the pressure in your arteries when your heart rests between beats (mmHg). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Body Temperature	Measures the normal body temperature of participants (°F). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
O2	Oxygen saturation measures the percentage of oxyhemoglobin in the blood (%). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
ETCO2	The level of carbon dioxide that is released at the end of an exhaled breath (mm Hg). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Respiratory Rate	Measures the breathing rate by number of breaths per minute (bpm). The measurement is an average calculated by dividing the sum of all three time points by 3. Their respective groups were collected at three time points.	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCO2	The amount of carbon dioxide in the blood in the arterial blood gas measurements (mm Hg).	Morning after night 1 and morning after night 2
PO2	The amount of oxygen in the blood by the arterial blood gas measurements (mm Hg).	Morning after night 1 and morning after night 2
Bicarbonate	The amount of bicarbonate in the blood by the arterial blood gas measurements (mmol/L).	Morning after night 1 and morning after night 2
pH	The amount of pH in the blood is measured by the arterial blood gas measurements.	Morning after night 1 and morning after night 2
Sleep Quality	This is measured by the Richards-Campbell Sleep Questionnaire, which is recorded on a 0-100 nm (minimum-maximum values) visual scale with higher scores indicating better sleep levels than lower scores.	Morning after night 1 and morning after night 2
Richard Campbell Sleep Questionnaire	The Richards-Campbell Sleep Questionnaire (RCSQ) is a six-question self-report questionnaire used to assess ICU patients' sleep quality. These six questions assess the domains of sleep depth, sleep latency, awakenings, ability to return to sleep, overall sleep quality, and overnight noise level. The responses were recorded on a 0-100 mm visual analog scale, with higher scores indicating better sleep levels than lower scores. The mean score represents the general perception of sleep quality.	Morning after night 1 and morning after night 2

Collaborators and Investigators

• Sponsor: Gaylord Hospital, Inc
• Investigators: Principal Investigator: Cheryl Tansley, SLP, Gaylord Specialty Healthcare

Publications and helpful links

General Publications

• Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
• Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
• Lian S, Teng L, Mao Z, Jiang H. Clinical utility and future direction of speaking valve: A review. Front Surg. 2022 Sep 8;9:913147. doi: 10.3389/fsurg.2022.913147. eCollection 2022.
• Liney T, Dawson R, Seth R, et al. Anxiety levels amongst patients with tracheostomies. British Journal of Anaesthesia. 2019;123(4):e504-e505. doi:10.1016/j.bja.2019.04.027
• O'Connor LR, Morris NR, Paratz J. Physiological and clinical outcomes associated with use of one-way speaking valves on tracheostomised patients: A systematic review. Heart Lung. 2019 Jul-Aug;48(4):356-364. doi: 10.1016/j.hrtlng.2018.11.006. Epub 2018 Dec 17.
• Passy V, Baydur A, Prentice W, Darnell-Neal R. Passy-Muir tracheostomy speaking valve on ventilator-dependent patients. Laryngoscope. 1993 Jun;103(6):653-8. doi: 10.1288/00005537-199306000-00013.
• Winters B, Serpas D, Fullmer N, Hughes K, Kincaid J, Rosario ER, Schnakers C. Sleep Quality Should Be Assessed in Inpatient Rehabilitation Settings: A Preliminary Study. Brain Sci. 2023 Apr 25;13(5):718. doi: 10.3390/brainsci13050718.
• DuBose JR, Hadi K. Improving inpatient environments to support patient sleep. Int J Qual Health Care. 2016 Oct;28(5):540-553. doi: 10.1093/intqhc/mzw079. Epub 2016 Aug 10.
• Martin JL, Fiorentino L, Jouldjian S, Josephson KR, Alessi CA. Sleep quality in residents of assisted living facilities: effect on quality of life, functional status, and depression. J Am Geriatr Soc. 2010 May;58(5):829-36. doi: 10.1111/j.1532-5415.2010.02815.x.
• Shuman AG, Duffy SA, Ronis DL, Garetz SL, McLean SA, Fowler KE, Terrell JE. Predictors of poor sleep quality among head and neck cancer patients. Laryngoscope. 2010 Jun;120(6):1166-72. doi: 10.1002/lary.20924.
• 510(k) Premarket Notification. U.S. Food and Drug Administration. Accessed June 23, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K962714
• Gross RD, Atwood C. R168: Safety of Tracheostomy Speaking Valve Use during Sleep. Otolaryngol Head Neck Surg. 2007;137(2_suppl):P209-P209. doi:10.1016/j.otohns.2007.06.505
• Silveira AR, Soki MN, Chone CT, Tah Y Ng R, Carvalho EG, Crespo AN. Brazilian tracheotomy speech valve: diaphragm pressure standardization. Braz J Otorhinolaryngol. 2009 Jan-Feb;75(1):107-10. doi: 10.1016/s1808-8694(15)30840-5.
• Barraza GY, Fernandez C, Halaby C, Ambrosio S, Simpser EF, Pirzada MB, Islam S. The safety of tracheostomy speaking valve use during sleep in children: a pilot study. Am J Otolaryngol. 2014 Sep-Oct;35(5):636-40. doi: 10.1016/j.amjoto.2014.04.011. Epub 2014 May 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Sleep Quality; Tracheostomy; Speaking Valve; LTACH; Passy-Muir Valve; Respiratory Care
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 201512TAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No