- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927860
Sleep and Activity Monitoring After Thoracic Surgery
January 7, 2019 updated by: Mark Allen, Mayo Clinic
Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Little is known about how sleep deprivation affects recovery after thoracic surgery.
There is some evidence that in cardiac surgery, sleep disturbance can lead to delayed recovery and mental status changes in the postoperative period.
There are no similar reports of studies after thoracic surgery.
We think that increased activity after surgery is beneficial for a rapid recovery and prevents blood clots, pneumonia and deconditioning.
Without specific data this is difficult to prove.
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mayo Clinic Rochester patients undergoing thoracic surgery
Description
Inclusion Criteria:
- undergoing thoracic surgery at Mayo Clinic Rochester
- expected to stay in hospital for at least 4 days
- signed consent form
Exclusion Criteria:
- Unable to provide consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of Stay
Time Frame: Until discharge, an average of 5 days
|
Until discharge, an average of 5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of pneumonia while hospitalized
Time Frame: Until discharge, an average of 5 days
|
Until discharge, an average of 5 days
|
Incidence of blood clot while hospitalized
Time Frame: Until discharge, an average of 5 days
|
Until discharge, an average of 5 days
|
Incidence of deconditioning while hospitalized
Time Frame: Until discharge, an average of 5 days
|
Until discharge, an average of 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark S Allen, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
August 8, 2017
Study Completion (Actual)
August 8, 2017
Study Registration Dates
First Submitted
October 6, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-006864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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