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

NCT ID: NCT06229639

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-02-28

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.

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

Conditions

Tracheostomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Tracheostomy Plug

Patients receive tracheostomy plug during night 2.

Group Type: ACTIVE_COMPARATOR

Tracheostomy Plug

Intervention Type: DEVICE

Passy-Muir Valve

Patients receive Passy-Muir Valve during night 1.

Group Type: EXPERIMENTAL

Passy Muir Valve

Intervention Type: DEVICE

Interventions

Passy Muir Valve

Intervention Type: DEVICE

Tracheostomy Plug

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Gaylord Hospital, Inc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gaylord Hospital

Wallingford, Connecticut, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 20667153 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36157432 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

201512TAN

Identifier Type: -

Identifier Source: org_study_id