Trial Outcomes & Findings for Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting (NCT NCT06229639)
NCT ID: NCT06229639
Last Updated: 2026-03-11
Results Overview
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.
COMPLETED
NA
33 participants
Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
2026-03-11
Participant Flow
Participant milestones
| Measure |
Passy-Muir Valve First, Then Tracheostomy Plug
All recruited participants who met eligibility criteria were given the Passy-Muir Valve and were monitored throughout night 1 with continuous telemetry. If no adverse events were observed, the protocol continued to night 2, where participants wore a tracheostomy plug. If well tolerated, participants continued with the tracheostomy plug throughout the night. Adverse events and vital signs were also monitored. The next morning, participants were asked to complete the Richard Campbell Sleep Questionnaire.
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|---|---|
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Overall Study
STARTED
|
30
|
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Overall Study
COMPLETED
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27
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Passy-Muir Valve First, Then Tracheostomy Plug
All recruited participants who met eligibility criteria were given the Passy-Muir Valve and were monitored throughout night 1 with continuous telemetry. If no adverse events were observed, the protocol continued to night 2, where participants wore a tracheostomy plug. If well tolerated, participants continued with the tracheostomy plug throughout the night. Adverse events and vital signs were also monitored. The next morning, participants were asked to complete the Richard Campbell Sleep Questionnaire.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Patient self decannulated
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1
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Overall Study
Respiratory staff accidentally removed PMV
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1
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Baseline Characteristics
Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
Baseline characteristics by cohort
| Measure |
Total
n=27 Participants
All participants received PMV on night 1 and Tracheostomy plug on night 2
|
|---|---|
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Age, Continuous
|
65.26 years
STANDARD_DEVIATION 12.18 • n=9 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Measures 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=26 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=26 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Heart Rate
|
84.10 beats per minute
Interval 78.54 to 89.67
|
84.33 beats per minute
Interval 78.84 to 89.82
|
PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Measures 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=26 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=26 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Systolic Blood Pressure
|
124.6 millimeters of mercury
Interval 117.4 to 131.8
|
127.6 millimeters of mercury
Interval 121.4 to 133.8
|
PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Measures 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=26 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=26 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Diastolic Blood Pressure
|
70.73 millimeters of mercury
Interval 67.67 to 73.79
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73.46 millimeters of mercury
Interval 70.46 to 76.46
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PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Measures 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=26 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=26 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Body Temperature
|
98.08 degrees Fahrenheit
Interval 97.96 to 98.19
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98.05 degrees Fahrenheit
Interval 97.95 to 98.14
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PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Oxygen 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=24 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=24 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
O2
|
96.29 percentage of oxygen saturation
Interval 95.58 to 97.01
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96.37 percentage of oxygen saturation
Interval 95.33 to 97.42
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PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00The 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=24 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=24 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
ETCO2
|
37.14 millimeters of mercury
Interval 34.87 to 39.4
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36.08 millimeters of mercury
Interval 33.09 to 39.08
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PRIMARY outcome
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00Measures 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=24 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=24 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Respiratory Rate
|
18.36 breaths per minute
Interval 17.28 to 19.44
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18.37 breaths per minute
Interval 17.41 to 19.34
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2The amount of pH in the blood is measured by the arterial blood gas measurements.
Outcome measures
| Measure |
Passy-Muir Valve
n=23 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=23 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
pH
|
7.452 pH
Interval 7.438 to 7.466
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7.439 pH
Interval 7.414 to 7.464
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2The amount of carbon dioxide in the blood in the arterial blood gas measurements (mm Hg).
Outcome measures
| Measure |
Passy-Muir Valve
n=23 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=23 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
PCO2
|
43.07 millimeters of mercury
Interval 39.46 to 46.68
|
44.86 millimeters of mercury
Interval 40.26 to 49.45
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2The amount of oxygen in the blood by the arterial blood gas measurements (mm Hg).
Outcome measures
| Measure |
Passy-Muir Valve
n=23 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=23 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
PO2
|
74.91 millimeters of mercury
Interval 69.3 to 80.53
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79.69 millimeters of mercury
Interval 72.37 to 87.01
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2The amount of bicarbonate in the blood by the arterial blood gas measurements (mmol/L).
Outcome measures
| Measure |
Passy-Muir Valve
n=22 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=22 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Bicarbonate
|
32.41 millimole per liter
Interval 26.29 to 38.54
|
30.38 millimole per liter
Interval 28.22 to 32.55
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2This 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=24 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=24 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Sleep Quality
|
65.19 score on a scale
Interval 55.38 to 75.01
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66.78 score on a scale
Interval 55.94 to 77.63
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SECONDARY outcome
Timeframe: Morning after night 1 and morning after night 2The 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.
Outcome measures
| Measure |
Passy-Muir Valve
n=24 Participants
Patients receive Passy-Muir Valve during night 1.
Passy Muir Valve
|
Tracheostomy Plug
n=24 Participants
Patients receive tracheostomy plug during night 2.
Tracheostomy Plug
|
|---|---|---|
|
Richard Campbell Sleep Questionnaire
|
65.19 score on a scale
Interval 55.38 to 75.01
|
66.78 score on a scale
Interval 55.94 to 77.63
|
Adverse Events
Tracheostomy Plug
Passy-Muir Valve
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place