Digital Incentive Spirometry for Thoracic Surgery

No longer recruiting at 5 trial locations

Overseen By Doraid Jarrar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Psychiatric conditions, Cognitive issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool designed to assist patients in using an incentive spirometer after lung surgery. An incentive spirometer helps patients take deep breaths to prevent post-surgery lung problems. The trial incorporates a digital version with a mobile app that sends reminders and tracks progress to encourage consistent use. Individuals who have undergone lung surgery and will use an incentive spirometer as part of their recovery may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions and enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

No, you do not have to stop taking your current medications to participate in this trial.

What prior data suggests that this digital incentive spirometry device is safe for post-surgery patients?

Studies have shown that incentive spirometry, a tool for breathing exercises, is safe and beneficial for patients. Research indicates it can reduce the risk of lung problems after surgery. Specifically, one study found a 32% lower risk of lung issues and a 17.9% decrease in pneumonia cases for patients using this tool.

Other studies have used digital versions of these devices, like the one being tested here, without major safety concerns. While the digital tool may not always prevent lung problems, it is generally well-tolerated. For those considering joining the study, current evidence suggests the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital incentive spirometry for thoracic surgery because it offers a modern twist on a traditional recovery tool. Unlike standard incentive spirometers, which are often simple plastic devices, this digital version includes a sensor that tracks inspiratory breaths and sends data wirelessly to a secure cloud database. This allows for real-time progress tracking and integrates gamification strategies and patient reminders through a mobile app, which can significantly enhance adherence and engagement in recovery exercises. These innovative features could improve patient outcomes by encouraging consistent use and providing healthcare providers with valuable insights into patient progress.

What evidence suggests that this digital incentive spirometry device is effective for improving spirometry adherence post-surgery?

Research has shown that using an incentive spirometer (IS) can reduce the risk of post-surgery complications. Patients using IS have a 32% lower risk of lung issues and a 17.9% lower risk of pneumonia compared to those who do not use it. However, some studies suggest that IS might not be effective for everyone in preventing these problems. In this trial, the digital spirometer and app aim to help patients follow their exercise routine more easily. These tools could enhance recovery by encouraging regular use. ^{2 3 4 5 6}

Who Is on the Research Team?

Doraid Jarrar, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for patients who have recently undergone major chest surgery and are required to perform pulmonary function tests using an incentive spirometer. Participants should be willing to use a digital version of this device along with a mobile app designed to track and encourage their usage.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I am not restricted by my current medications.

Exclusion Criteria

History of prior non-compliance to prescribed therapy or presence or history of significant psychiatric condition (e.g., drug or alcohol addiction, psychosis, schizophrenia), or cognitive issue which would make it difficult for the patient to comply with the study procedures or follow the investigator's instructions

Pregnant individuals due to low likelihood of meeting inclusion criteria 4

Populations for whom incentive spirometry is deemed inappropriate due to medical condition or otherwise

Timeline for a Trial Participant

Preoperative Assessment

Preoperative assessments including DLCO, FVC, TLC, VC, FEV-1, and RV measurements

Up to 2 weeks before surgery

Postoperative Treatment

Use of digital incentive spirometer and mobile app to assess and promote spirometry adherence

Till discharge or up to 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Incentive Spirometry

Trial Overview

The study is testing whether a digital incentive spirometer, paired with a mobile app that includes reminders, gamification, and progress tracking, can improve patient adherence to post-surgery breathing exercises compared to standard practices.

How Is the Trial Designed?

Group I: Single arm proof of concept study of a digital incentive spirometer Experimental Treatment 1 Intervention

This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In a systematic review of 592 participants from seven studies, incentive spirometry (IS) showed no significant difference in preventing postoperative pulmonary complications compared to other physiotherapy methods in adults undergoing coronary artery bypass graft (CABG).

Patients using IS actually experienced worse pulmonary function and arterial oxygenation than those receiving positive pressure breathing techniques, indicating that IS may not be beneficial and could potentially have negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft. Freitas, ER., Soares, BG., Cardoso, JR., et al.[2023]

Incentive spirometry, commonly used after thoracic surgery, has not shown clear clinical benefits in reducing postoperative pulmonary complications or hospital stays for the general thoracic surgical patient population.

However, emerging evidence suggests that it may be beneficial for higher-risk patients, such as those with COPD, in reducing postoperative complications, despite challenges with patient adherence to the prescribed use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentive Spirometry for Prevention of Postoperative Pulmonary Complications After Thoracic Surgery. Kotta, PA., Ali, JM.[2023]

In a study of 7549 lung cancer patients undergoing video-assisted thoracic surgery (VATS), the use of incentive spirometry (IS) significantly reduced hospitalization costs by an average of $524.50 and decreased the risk of pneumonia (odds ratio of 0.55) compared to those not using IS.

While IS was more commonly used in patients undergoing thoracotomy (68.4%) than in those undergoing VATS (53.1%), it did not lead to differences in emergency department visits or hospitalizations at 3, 6, or 12 months post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is incentive spirometry beneficial for patients with lung cancer receiving video-assisted thoracic surgery? Liu, CJ., Tsai, WC., Chu, CC., et al.[2020]

A large majority of healthcare professionals (over 90%) believe that incentive spirometry (IS) is essential for patient care and effective in improving pulmonary function and preventing complications like atelectasis and pneumonia, despite limited clinical effectiveness data.

There is significant variability in the perceived appropriate use of IS among healthcare professionals, highlighting a disconnect between their beliefs and the lack of standardized protocols and evidence supporting its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on Incentive Spirometry Utility and Patient Protocols. Eltorai, AEM., Baird, GL., Eltorai, AS., et al.[2018]

Incentive spirometry is a useful tool for assessing lung function and respiratory recovery in patients after thoracic surgery, based on a review of seven key studies.

While incentive spirometry can aid in monitoring recovery, it does not replace the need for regular physiotherapy, which is more effective in reducing postoperative complications and improving lung function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is incentive spirometry effective following thoracic surgery? Agostini, P., Calvert, R., Subramanian, H., et al.[2008]

In a study of 50 adult patients with rib fractures, the use of an incentive spirometer (IS) significantly reduced the rate of pulmonary complications, with only 29.2% of the IS group experiencing complications compared to 80.7% in the control group.

Patients using the IS also showed significant improvements in lung function, as measured by forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1), indicating that the IS is an effective and safe intervention for enhancing recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial. Sum, SK., Peng, YC., Yin, SY., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11720981/

The Role of Incentive Spirometry in Enhanced Recovery After ...

IS group showed trends toward shorter hospital stays and lower time to chest drain removal, though without reaching statistical significance.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1015958422015883

Review Article Incentive spirometry is an effective strategy ...

Patients undergoing IS also had reduced risk of PPCs (32%) and postoperative pneumonia (17.9%) with statistical significance than patients not undergoing IS ( ...

3.

withpower.com

withpower.com/trial/phase-adherence-patient-9-2024-97d3c

Digital Incentive Spirometry for Thoracic Surgery

In a systematic review of 592 participants from seven studies, incentive spirometry (IS) showed no significant difference in preventing postoperative pulmonary ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07109934

Compare the Effect of Incentive Spirometry Versus Chest ...

The findings likely reveal that both methods positively impact lung expansion and oxygenation, but one may be superior in enhancing recovery and ...

5.

karger.com

karger.com/res/article/100/11/1114/829076/Use-of-Incentive-Spirometry-in-Adults-following

Use of Incentive Spirometry in Adults following Cardiac ...

This meta-analysis showed that IS alone likely results in little to no reduction in the number of adult patients with PPCs, in mortality, or in the LHS.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12357117/

Gamification of Incentive Spirometry in Trauma Patients

OmniFlow offers a promising, much-needed solution for promoting adherence to breathing exercises among patients with thoracic trauma. This study ...