Pneumonia, Ventilator-Associated, Pulmonary Atelectasis
Conditions
Brief summary
This is a pilot study to obtain preliminary information on the usability and efficacy of a pre-habilitation program. The investigators will recruit up to 100 patients. The two specific aims of this study are to conduct an initial pilot study with the following goals: 1. To obtain information on feasibility and utilization of the program 2. To determine whether participation in the program improves a patient's Maximal Inspiratory Pressure
Detailed description
Participants will engage in a pre-habilitation program prior to surgery at home, that includes using an inspiratory muscle training (IMT) device that will strengthen the muscles of breathing. Participants will keep a log of training. The Maximum Inspiratory Pressure will be measured at baseline and prior to surgery.
Interventions
BEHAVIORALInspiratory Muscle Training (IMT)
Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All participants will receive the same intervention.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing thoracic or upper abdominal surgery with an estimated date of surgery between 2-10 weeks after enrollment * Age\>65 y/o
Exclusion criteria
* Impaired cognition that would limit participation in the program * History of spontaneous pneumothorax * Any other physician judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Inspiratory muscle training compliance as assessed by daily logs | Up to 10 Weeks | The primary outcome variable will be compliance with \>70% of inspiratory muscle training. Patients will be instructed to follow the prescribed program daily from the day consent is obtained until the day of surgery. Patients will complete a daily log of breathing exercises. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempted inspiratory muscle training as assessed by percent days the program was attempted | Up to 10 Weeks | Secondary feasibility outcome variables will be compliance (percent days the program was attempted). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery. |
| Number of completed inspiratory muscle training as assessed by percent days with full compliance | Up to 10 Weeks | Secondary feasibility outcome variables will be compliance (percent days with full compliance). Patients will complete a daily log of breathing exercises and document the completion of each breathing exercise. The amount of days to be measured will be the number of days from consent to the day of surgery. |
| Change in maximum inspiratory pressure | Baseline and on the day of surgery, up to 10 weeks from enrollment | The change in maximum inspiratory pressure will be determined by comparing the baseline maximum inspiratory pressure to the maximum inspiratory pressure on the day of surgery to assess the efficacy of the inspiratory muscle training. |
| Interest in Using Program for Future Surgeries as assessed by a likert scale | Day of Surgery, up to 10 weeks from enrollment | The patient's willingness to use this program for future surgeries will be measured using the Likert scale 1 to 5. Higher scores mean more willingness to use program for future surgeries. |
| Overall Satisfaction with the Program as assessed by a likert scale | Day of Surgery, up to 10 weeks from enrollment | The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction. |
Countries
United States
Outcome results
None listed