Trial Outcomes & Findings for OPEP Devices in Acute Inpatient Treatment of Pneumonia (NCT NCT04540510)

Last Updated: 2021-09-24

Results Overview

Number of days that the patient stays in hospital was collected from medical record. We have calculated the mean and the standard deviation for both groups.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

duration of hospital stay, an expected average of 4 days

Results posted on

2021-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	OPEP Therapy Added to Standard Pneumonia Care The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

OPEP Devices in Acute Inpatient Treatment of Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.	Total n=11 Participants Total of all reporting groups
Age, Continuous	75.6 years STANDARD_DEVIATION 20.0 • n=5 Participants	78.2 years STANDARD_DEVIATION 11.3 • n=7 Participants	77 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI	37.4 kg/m^2 STANDARD_DEVIATION 0.8 • n=5 Participants	24.7 kg/m^2 STANDARD_DEVIATION 3.0 • n=7 Participants	30.4 kg/m^2 STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Population: Although 6 subjects were recruited in the control group, however, we are missing this variable in data collection sheet for one subject in the control group. Therefore, we have only evaluated 5 subjects in the control group for this analysis.

Number of days that the patient stays in hospital was collected from medical record. We have calculated the mean and the standard deviation for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=5 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Length of Hospital Stay	1.2 days Standard Deviation 0.9	4.0 days Standard Deviation 1.2

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Dyspnea as measured by modified-Borg score, minimum value 0 (No shortness of breath) and maximum value 10 (Maximal breathlessness). Score scale is from 0-10. We have calculated the mean and the standard deviation for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Reported Dyspnea by Modified-Borg Score	1.2 score on scale Standard Deviation 3.8	2.4 score on scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Duration of antibiotics was collected from medical record. We have calculated the mean and the standard deviation for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=5 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Duration of Antibiotics	8.8 days Standard Deviation 4.5	7.4 days Standard Deviation 4.3

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Duration of fever was collected from medical record. We have calculated the mean and the standard deviation for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Duration of Fever	NA days Standard Deviation NA no participants in the Treatment Group had fever	0.8 days Standard Deviation 1.0

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Number of participants with need for oxygen supplement at the time of hospital discharge was collected from medical record for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Number of Participants With Need for Oxygen Supplement at Hospital Discharge	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 day after the hospital discharge

Number of total hospital readmissions post-enrollment was obtained from medical record.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Reported 30-, 60-, and 90-day Readmission Rates	0 Participants	0 Participants

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Data on the diagnosis of organism by sputum (positive sputum culture) was collected from medical record. We have counted number of participants with intervention and without intervention.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=5 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Number of Participants With Positive Sputum Culture	1 Participants	3 Participants

SECONDARY outcome

Timeframe: duration of hospital stay, an expected average of 4 days

Number of participants transferred to the intensive care unit post enrollment was obtained from medical record for both groups.

Outcome measures

Outcome measures
Measure	OPEP Therapy Added to Standard Pneumonia Care n=5 Participants The intervention group will be asked to use an OPEP device twice daily, with the help of study investigators, for a total of at least 5 minutes per session. This treatment will be in addition to the usual care that the hospital physician prescribe for them to treat the pneumonia.	Standard Pneumonia Care n=6 Participants The control group will continue to receive the usual care that their hospital team prescribe for them to treat the pneumonia.
Number of Participants Transferred to the Intensive Care Unit (ICU)	1 Participants	1 Participants

Adverse Events

OPEP Therapy Added to Standard Pneumonia Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Pneumonia Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joann Petrini

Nuvance Health (formerly Western Connecticut Health Network)

Phone: 203-739-6882

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place