The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry

NCT03686631 | Completed

• 1 other identifier: 2018P000230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the protocol is to assess how incentive spirometer data gathered via a smartphone platform can be utilized to improve participant adherence to prescribed incentive spirometer exercises in the post-operative period. Half of the participants will receive a standard of care incentive spirometer with a passive tracking device while the other half of the participants will receive a smartphone connected device and smartphone with an application that will encourage their use.

Conditions

Post-Op Infection; Adherence, Patient; Pulmonary Atelectasis; Incentive Spirometry; Post-Op Complication

Keywords

respiratory therapy; Pulmonary Atelectasis; perioperative medicine; incentive spirometry; smartphone

Outcome Measures

Primary Outcomes (1)

• Adherence to prescribed post-operative incentive spirometer exercises

  The primary outcome of the study will be a measure of how adherent the participant has been to the prescribed post-operative incentive spirometer exercises. Participants are prescribed ten breathing exercises per hour using the spirometer and the electronic devices in both arms will record how often the participant utilizes the device, measured on an hourly basis.

  Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

Secondary Outcomes (3)

• Incidence of Post-Operative Pulmonary Complications

  Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

• Incidence of post-operative respiratory infection

  Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

• Incidence of clinically relevant complications

  Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.

Study Arms (2)

Passive Arm

NO INTERVENTION

This arm uses a passive tracking device to assess the number of times a patient uses their prescribed incentive spirometer.

Smartphone Arm

EXPERIMENTAL

This arm uses a smartphone connected device and smartphone application to remind and encourage patients to use the spirometer as well as track the number of times they utilize the spirometer.

Behavioral: Smartphone Arm

Interventions

Smartphone Arm BEHAVIORAL

The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a "gamified" application for that patient to do so.

Smartphone Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists Physical Class (ASA) 1-3 patients undergoing elective Surgery at BIDMC requiring Incentive Spirometer use in the post-op period
• Greater than 18 years of age.
• Required to have a Pre-Anesthesia Testing Clinic Appointment
• Able to understand and sign a study consent form
• Able to understand and utilize a smartphone application

You may not qualify if:

• Diagnosis of Obstructive Sleep Apnea (OSA), treatment with CPAP or BIPAP for OSA
• Lack of regular smartphone use, or visual, mental or motor impairment that impedes use of smartphone
• Upper extremity surgery resulting in temporary or permanent inability to use two hands with spirometer device
• ASA 4 or greater, any ASA-E status (emergency surgical procedure)
• Suspected or established respiratory infection
• Previous spontaneous pneumothorax
• Severe pulmonary disease, or use of home O2
• Does not speak or understand English

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

• do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.

  PMID: 24510642 BACKGROUND

• Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.

  PMID: 24155356 BACKGROUND

• Warner DO. Preventing postoperative pulmonary complications: the role of the anesthesiologist. Anesthesiology. 2000 May;92(5):1467-72. doi: 10.1097/00000542-200005000-00037. No abstract available.

  PMID: 10781293 BACKGROUND

• THOREN L. Post-operative pulmonary complications: observations on their prevention by means of physiotherapy. Acta Chir Scand. 1954 May 5;107(2-3):193-205. No abstract available.

  PMID: 13188561 BACKGROUND

• Bartlett RH, Gazzaniga AB, Geraghty TR. Respiratory maneuvers to prevent postoperative pulmonary complications. A critical review. JAMA. 1973 May 14;224(7):1017-21. No abstract available.

  PMID: 4574097 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Pulmonary Atelectasis; Postoperative Complications

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charlie Safran, MD MS

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor / statistician will be blinded to which group each patient is in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Clinical Informatics

Model Details: Patients will be enrolled randomly into either the passive arm or the smartphone arm prior to their surgery.

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: September 27, 2018
• Study Start: July 9, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)