Clinical trial NCT03686631: The Digital Incentive Spirometer (DIS): Improving Adherence to Incentive Spirometry
Official title: A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Infection
Adherence, Patient
Pulmonary Atelectasis
Incentive Spirometry
Post-Op Complication
Keywords: respiratory therapy
Pulmonary Atelectasis
perioperative medicine
incentive spirometry
smartphone
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be enrolled randomly into either the passive arm or the smartphone arm prior to their surgery.
Primary purpose: PREVENTION

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.

Detailed description: This study is a prospective, randomized, participant blinded, single center, clinical trial to ascertain whether a smartphone connected digital incentive spirometer, the Smartpeakflow™, can improve participant adherence to prescribed incentive spirometer exercises. A control group will be given the Beth Israel Deaconess Medical Center (BIDMC) standard Voldyne Incentive Spirometer with an attached microcontroller that will record use of the spirometer. The study group will be given the Smartpeakflow ™ connected to an android motherboard (microcomputer, aka smartphone) running Android OS, that will then record use and store this data on the smartphone itself. Participants will then use an app on the BIDMC provided smartphone to view their usage and receive encouragement to continue using their device. All data on use will be recorded locally and there will be no internet connection or communication with participant through this device at any time.

The study is designed as a technology evaluation to assess feasibility, usability and assess for early impact on our outcome measures. The investigators plan to enroll up to 50 participants to participate in this study.

At the time of enrollment, participants who meet the inclusion criteria, and none of the exclusion criteria, will be asked to opt in to the study. Participants will read information about the study and research staff will explain what it means to "opt in". Prospective participants will be given ample time to read the informed consent form and ask any questions.

Once enrolled, participants will be randomized electronically to either the study group or control group. Participants that are randomized to the control group will have no further training or instructions at the Pre-Anesthesia Testing Clinic. Participants that are in the study group will be instructed on how to use the smartphone application and device which will then be provided to them in the Post Anesthesia Care Unit after their surgery. Both groups will retain and utilize the spirometers throughout their hospital stay, and the devices will be collected by the investigators when the participant is discharged from the hospital.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adherence to prescribed post-operative incentive spirometer exercises
timeFrame: 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:
measure: Incidence of Post-Operative Pulmonary Complications
timeFrame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
measure: Incidence of post-operative respiratory infection
timeFrame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
measure: Incidence of clinically relevant complications
timeFrame: Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner.
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Charlie Safran, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832.
citation: 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.
citation: 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.
citation: 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.