Post-Op Complication Clinical Trial
— DISOfficial title:
A Behavioral Study of Digital Technology for Improving Post-Operative Incentive Spirometer Adherence
Verified date | September 2019 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 14, 2019 |
Est. primary completion date | August 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | BIDMC | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Bartlett RH, Gazzaniga AB, Geraghty TR. Respiratory maneuvers to prevent postoperative pulmonary complications. A critical review. JAMA. 1973 May 14;224(7):1017-21. — View Citation
Branson RD. The scientific basis for postoperative respiratory care. Respir Care. 2013 Nov;58(11):1974-84. doi: 10.4187/respcare.02832. Review. — View Citation
do Nascimento Junior P, Módolo NS, Andrade S, Guimarães 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;(2):CD006058. doi: 10.1002/14651858.CD006058.pub3. Review. — View 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. — View Citation
Warner DO. Preventing postoperative pulmonary complications: the role of the anesthesiologist. Anesthesiology. 2000 May;92(5):1467-72. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of Post-Operative Pulmonary Complications | Pulmonary related complications and events such as radiographic exams, increased utilization of oxygen therapy, use of accessory breathing devices (BiPAP, CPAP). The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | |
Secondary | Incidence of post-operative respiratory infection | Diagnosis of respiratory infection, such as pneumonia, in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. | |
Secondary | Incidence of clinically relevant complications | Diagnosis of clinically relevant complications such as surgical site infection, falls, delerium, or any other non-pulmonary event in the post-operative period. The measure will be dichotomous outcome based on whether event took place or not. | Enrollment after patient finishes their surgery and data collection continues until patient is discharged home, or up to 2 weeks, whichever is sooner. |
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