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

NCT06229639 | Completed Results FDA Device

• 1 other identifier: 201512TAN
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tracheostomy

Keywords

Tracheostomy; Speaking Valve; Sleep Quality; LTACH; Passy-Muir Valve; Respiratory Care

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (6)

• pH

  Morning after night 1 and morning after night 2

• PCO2

  Morning after night 1 and morning after night 2

• PO2

  Morning after night 1 and morning after night 2

• Bicarbonate

  Morning after night 1 and morning after night 2

• Sleep Quality

  Morning after night 1 and morning after night 2

Study Arms (2)

Tracheostomy Plug

ACTIVE COMPARATOR

Patients receive tracheostomy plug during night 2.

Device: Tracheostomy Plug

Passy-Muir Valve

EXPERIMENTAL

Patients receive Passy-Muir Valve during night 1.

Device: Passy Muir Valve

Interventions

Tracheostomy Plug DEVICE

Tracheostomy Plug

Passy Muir Valve DEVICE

Passy-Muir Valve

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead

Study Sites (1)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Related Publications (14)

• Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.

  PMID: 20667153 BACKGROUND

• 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.

  PMID: 36157432 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 30573194 BACKGROUND

• 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.

  PMID: 8502098 BACKGROUND

• 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.

  PMID: 37239190 BACKGROUND

• 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.

  PMID: 27512130 BACKGROUND

• 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.

  PMID: 20722819 BACKGROUND

• 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.

  PMID: 20513034 BACKGROUND

• 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

  BACKGROUND

• 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. Erratum In: Am J Otolaryngol. 2016 Sep-Oct;37(5):477. doi: 10.1016/j.amjoto.2016.07.001.. Islam S [added].

  PMID: 24888795 BACKGROUND

• 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

  BACKGROUND

• Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.

  PMID: 11227580 BACKGROUND

• 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.

  PMID: 19488569 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Limitations and Caveats

This study is limited by a small sample size, short duration, lack of randomization, and the high-acuity LTACH patient population, whose comorbidities may affect sleep quality. Since only decannulation candidates were included, findings may not generalize to others or reflect outcomes if PMV use began earlier. Larger, randomized, longer studies comparing early vs. late nighttime PMV use are needed to better assess its impact on sleep and clinical outcomes.

Results Point of Contact

• Title: Socheata Morley
• Organization: Gaylord Specialty Healthcare

smorley@gaylord.org

2036793563

Study Officials

• Cheryl Tansley, SLP

  Gaylord Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 29, 2024
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)