Preoperative Optimization to Improve Functional Status

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

Preoperative Optimization to Improve Functional Status

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04566172
• Other study ID #: IRB00227450
• Status: Withdrawn
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2027
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Pulmonary Atelectasis

Intervention

Behavioral:
• Inspiratory Muscle Training (IMT)
Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.

Locations

Country	Name	City	State
United States	The Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Inspiratory muscle training compliance as assessed by daily logs	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.	Up to 10 Weeks
Secondary	Number of attempted inspiratory muscle training as assessed by percent days the program was attempted	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.	Up to 10 Weeks
Secondary	Number of completed inspiratory muscle training as assessed by percent days with full compliance	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.	Up to 10 Weeks
Secondary	Change in maximum inspiratory pressure	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.	Baseline and on the day of surgery, up to 10 weeks from enrollment
Secondary	Interest in Using Program for Future Surgeries as assessed by a likert scale	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.	Day of Surgery, up to 10 weeks from enrollment
Secondary	Overall Satisfaction with the Program as assessed by a likert scale	The patient's satisfaction with the program will be measure using the Likert scale 1 to 5. Higher scores mean better satisfaction.	Day of Surgery, up to 10 weeks from enrollment