Tracheostomy
Conditions
Keywords
Tracheostomy, Speaking Valve, Sleep Quality, LTACH, Passy-Muir Valve, Respiratory Care
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
Interventions
DEVICEPassy Muir Valve
DEVICETracheostomy Plug
Sponsors
Gaylord Hospital, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). 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. |
| 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). 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. |
| 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). 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. |
| 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). 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. |
| O2 | Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00 | 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. |
| 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). 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. |
| 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). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pH | Morning after night 1 and morning after night 2 | The amount of pH in the blood is measured by the arterial blood gas measurements. |
| 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 0-100 nm (minimum-maximum values) visual scale with higher scores indicating better sleep levels than lower scores. |
| Richard Campbell Sleep Questionnaire | Morning after night 1 and morning after night 2 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCheryl Tansley, SLP
Gaylord Specialty Healthcare
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.26 years STANDARD_DEVIATION 12.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed