Digital Incentive Spirometry Adherence

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Function; Incentive Spirometry; Patient Adherence; Lung Resection; Thoracic Surgery
• Interventions: Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.

• Registration Number: NCT06629454
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-04
• Study First Posted: 2024-10-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Study Start: 2025-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, 18 years or older.
4. Undergoes any anatomic lung resection surgery
5. An incentive spirometer is expected to be ordered for the patient as standard-of-care
6. There is no restriction on active medications.

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Exclusion Criteria

There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study:

1. Vulnerable populations who in the opinion of the investigator are unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
2. 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 in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
3. Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise.
4. Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm proof of concept study of a digital incentive spirometer	Adherence to digital incentive spirometer in the postop period after major chest surgery.	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.

Primary Outcome Measures

Name	Time	Method
Total incentive spirometry adherence	Till discharge or up to 7 days	Number of inspiratory breath attempts performed with the digital IS per day.
Consistency of incentive spirometry adherence throughout postoperative stay	Till discharge or up to 7 days	Percent of recorded hours in which at least one inspiratory breath was attempted using the digital IS.

Secondary Outcome Measures

Name	Time	Method
Flow rate of inspiratory breaths attempted from the digital IS	Till discharge or up to 7 days	Average flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device
Blood oxygen saturation	Till discharge or up to 7 days	Postoperative SpO2
Volume of inspiratory breaths attempted with the digital IS	Till discharge or up to 7 days	Inspiratory volume in milliliters measured from one inhalation from the device
Pain Scores	Till discharge or up to 7 days	Postoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain).

Trial Locations

Locations (6)

Penn Medicine Cherry Hill; 🇺🇸 Cherry Hill, New Jersey, United States

Penn Medicine Valley Forge; 🇺🇸 Berwyn, Pennsylvania, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Medicine University City; 🇺🇸 Philadelphia, Pennsylvania, United States

Penn Thoracic Surgery Presbyterian; 🇺🇸 Philadelphia, Pennsylvania, United States

Perelman Center for Advanced Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States