Postoperative Care Clinical Trial
Official title:
Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?
Verified date | October 2017 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing an elective surgical procedure in colorectal services at Emory University Hospital Exclusion Criteria: - Post-surgical admission into the intensive care unit (ICU) - Have an open abdomen due to surgical complications - Wound Vacuum Assisted Closure (VAC) dependent |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of number of steps taken between study arms | The number of steps taken by each participant will be measured by a Fitbit, which is a wireless activity tracking device. The number of steps taken will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. The Fitbit is commercially available and is worn on the wrist. Data will be collected from the Fitbit wirelessly using a dedicated study data collection phone and linked with an anonymized patient identifier. Data collection phones attached to chargers will be placed in patient rooms within range of the hospital bed to enable automatic wireless data collection. | Up to 10 days (postoperative day 0 through postoperative day 9) | |
Secondary | Comparison of time to first ambulation between study arms | The duration of time from administration of the Fitbit device until first postoperative ambulation will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Participants cleared to ambulate will be given a package containing the Fitbit device, paired study phone, and chargers while in the Post Anesthesia Care Unit (PACU). Participants will be instructed to equip the device prior to discharge from the PACU. | Up to 10 days (postoperative day 0 through postoperative day 9) | |
Secondary | Comparison of incidence of prolonged postoperative ileus between study arms | The incidence of prolonged postoperative ileus during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. For this study, postoperative ileus is defined as the interval from surgery until there is passage of flatus or stool and an oral diet is tolerated. Prolonged postoperative ileus is determined to be present if two or more of the following criteria are met on or after postoperative day 4, without prior resolution of postoperative ileus: Nausea or vomiting The inability to tolerate an oral diet over 24 hours Absence of flatus over 24 hours Abdominal distension Radiologic confirmation |
Up to 10 days (postoperative day 0 through postoperative day 9) | |
Secondary | Comparison of incidence of pulmonary complications between study arms | The incidence of pulmonary complications during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. For this study, pulmonary complications are defined as respiratory failure requiring mechanical ventilation, pneumonia, atelectasis requiring bronchoscopic intervention, or pneumothorax or pleural effusion requiring percutaneous intervention. | Up to 10 days (postoperative day 0 through postoperative day 9) | |
Secondary | Comparison of incidence of venous thromboembolism between study arms | The incidence of venous thromboembolism occurring during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Venous thromboembolism is when a blood clot (thrombus) forms within a vein and includes deep vein thrombosis (DVT) and pulmonary embolism (PE). | Up to 10 days (postoperative day 0 through postoperative day 9) | |
Secondary | Comparison of length of postoperative hospital stay between study arms | The length of hospitalization following surgery will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. | Up to 10 days (postoperative day 0 through postoperative day 9) |
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