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N/A

MIR Spirobank G for Abdominal Surgery

N/A

Waitlist Available

Led By Chet Hammill, M.D., MCR

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to postoperative day 3

Awards & highlights

Study Summary

This trial will test whether a device that encourages patients to do deep-breathing exercises before and after surgery can improve post-operative outcomes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to postoperative day 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to postoperative day 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to postoperative day 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Forced Expiratory Volume in One Second Parameter (FEV1)

Change in Forced Vital Capacity (FVC)

Change in Pulse Oximetry

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Pre-Surgery: Standard Incentive Spirometry (IS)Experimental Treatment1 Intervention

Will receive a conventional spirometer prior to surgery Will be asked to perform spirometry 30 times per day.

Group II: Pre-Surgery: Digital Incentive Spirometry (IS) + Text MessageExperimental Treatment2 Interventions

Will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results. Will be asked to perform spirometry 10 times per hour, every hour while awake, every day for at least 7 days prior to surgery. Absence of spirometry for 24 hours will trigger a text message reminder to encourage compliance with IS.

Group III: Post-Surgery: Digital Incentive Spirometry (IS) + Text MessageExperimental Treatment2 Interventions

After surgery, the participants will receive the digital incentive spirometer (Spirobank G) that is compatible with health monitoring software developed by ZEPHYRx®. The digital spirometer couples with a HIPAA-compliant mobile application that calculates and stores pulmonary function test (PFT) results. Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3 Will receive text reminders to perform spirometry if they do not perform spirometry in a 24-hour period.

Group IV: Pre-Surgery: No Incentive Spirometry (IS)Active Control1 Intervention

-Will not receive a incentive spirometer prior to surgery

Group V: Post-Surgery: Standard Incentive Spirometry (IS)Active Control1 Intervention

After surgery, the participants will receive a conventional spirometer. Will be instructed to perform spirometry 10 times per hour, every hour while awake through postoperative Day 3 The conventional spirometer will be equipped with an accelerometer that will allow the research team to determine whether the spirometer moves throughout the patients' postoperative stay (as a proxy for IS use)

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,707 Total Patients Enrolled

Chet Hammill, M.D., MCRPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this medical experiment?

"Indeed, records on clinicaltrials.gov indicate this medical experiment is presently enrolling individuals. It was initially posted on May 3rd 2022 and its details were most recently revised a day later; 156 participants are required from one location."

Answered by AI

Are any enrollees being recruited for this investigation presently?

"According to clinicaltrials.gov, this research effort is actively trying to source participants - it was first announced on May 3rd 2022 and the listing was recently revised on the following day."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery

2022. "Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04887922.