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

Not Applicable

Completed

• Conditions: Tracheostomy

• Registration Number: NCT06229639
• Lead Sponsor: Gaylord Hospital, Inc

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

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-01
• Study Completion: 2018-02
• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Heart rate	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Measures the number of contractions of the heart per minute (bpm).
Diastolic blood pressure	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Measures the pressure in your arteries when your heart rests between beats (mmHg).
O2	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Oxygen saturation measures percentage of oxyhemoglobin in the blood (%).
ETCO2	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	The level of carbon dioxide that is released at the end of an exhaled breath (mm Hg).
Respiratory Rate	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Measures the breathing rate by number of breaths per minute (bpm).
Systolic Blood Pressure	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Measures the pressure in your arteries when your heart beats (mmHg).
Body Temperature	Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00	Measures the normal body temperature of participants (°F).

Secondary Outcome Measures

Name	Time	Method
PCO2	Morning after night 1 and morning after night 2	The amount of carbon dioxide in the blood in the arterial blood gas measurements (mm Hg).
PO2	Morning after night 1 and morning after night 2	The amount of oxygen in the blood by the arterial blood gas measurements (mm Hg).
Bicarbonate	Morning after night 1 and morning after night 2	The amount of bicarbonate in the blood by the arterial blood gas measurements (mmol/L).
Sleep Quality	Morning after night 1 and morning after night 2	This is measured by the Richards-Campbell Sleep Questionnaire, which is recorded on a 100 nm visual scale with higher scores indicating better sleep levels than lower scores.
pH	Morning after night 1 and morning after night 2	The amount of pH in the blood measured by the arterial blood gas measurements.

Trial Locations

Locations (1)

Gaylord Hospital; 🇺🇸 Wallingford, Connecticut, United States