Thoracic SurgeryNCT02927860
Sleep and Activity Monitoring After Thoracic Surgery
An observational study of Thoracic Surgery and Surgery, Thoracic, run by Mayo Clinic at 1 site in United States.
Trial summary
Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, Surgery, Thoracic
- What is being tested?
- Fitbit
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 8 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mayo Clinic Rochester patients undergoing thoracic surgery
Who may be able to join
- undergoing thoracic surgery at Mayo Clinic Rochester
- expected to stay in hospital for at least 4 days
- signed consent form
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.
Read the 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.
- Conditions
- Thoracic Surgery, Surgery, Thoracic
- Being tested
- Fitbit
- Keywords
- sleep, exercise, activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
A FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Measured: Until discharge, an average of 5 days
Secondary outcomes (3)
Incidence of pneumonia while hospitalized
Measured: Until discharge, an average of 5 days
Incidence of blood clot while hospitalized
Measured: Until discharge, an average of 5 days
Incidence of deconditioning while hospitalized
Measured: Until discharge, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Why it stopped: Fitbit was not giving the necessary data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Allen, Mayo Clinic
- Investigators
- Mark S Allen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927860
- Sponsor's protocol ID
- 16-006864
- Status last verified
- Jan 2019
- First submitted
- 6 Oct 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Activity Monitoring After Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02927860
- Acronym / sponsor ID
- 16-006864
- Conditions
- Thoracic Surgery, Surgery, Thoracic
- Keywords
- sleep, exercise, activity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Fitbit was not giving the necessary data.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mayo Clinic Rochester patients undergoing thoracic surgery
Key inclusion criteria (3 listed)
- undergoing thoracic surgery at Mayo Clinic Rochester
- expected to stay in hospital for at least 4 days
- signed consent form
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitA FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer. | Other | – |
Primary outcome
Length of Stay
Time frame: Until discharge, an average of 5 days
3 secondary outcomes
Incidence of pneumonia while hospitalized
Time frame: Until discharge, an average of 5 days
Incidence of blood clot while hospitalized
Time frame: Until discharge, an average of 5 days
Incidence of deconditioning while hospitalized
Time frame: Until discharge, an average of 5 days
Results and safety
The study was stopped early (reason given: Fitbit was not giving the necessary data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Allen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Surgery, Thoracic, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Fitbit was not giving the necessary data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: Until discharge, an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.