Clinical trial NCT06229639: Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
Official title: Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy
Keywords: Tracheostomy
Speaking Valve
Sleep Quality
LTACH
Passy-Muir Valve
Respiratory Care
Lead sponsor: Gaylord Hospital, Inc
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Heart rate
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: Systolic Blood Pressure
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: Diastolic blood pressure
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: Body Temperature
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: O2
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: ETCO2
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
measure: Respiratory Rate
timeFrame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
Secondary outcomes:
measure: PCO2
timeFrame: Morning after night 1 and morning after night 2
measure: PO2
timeFrame: Morning after night 1 and morning after night 2
measure: Bicarbonate
timeFrame: Morning after night 1 and morning after night 2
measure: Sleep Quality
timeFrame: Morning after night 1 and morning after night 2
measure: pH
timeFrame: Morning after night 1 and morning after night 2
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Hospital
state: Connecticut
Study officials:
References:
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