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.
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
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
33
Gaylord Hospital
Wallingford, Connecticut, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
pH
The amount of pH in the blood is measured by the arterial blood gas measurements.
Time frame: Morning after night 1 and morning after night 2
PCO2
The amount of carbon dioxide in the blood in the arterial blood gas measurements (mm Hg).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Morning after night 1 and morning after night 2