PerfusionNCT03121443
Patient Positions and Perfusion Index
An observational study of Perfusion, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The association between patient positions including supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and perfusion index. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Perfusion
- What is being tested?
- Perfusion index
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2017to 5 Jul 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Volunteers American society of anesthesiologists score of 1
Who may be able to join
- American society of anesthesiologists score of 1
Who cannot join
- any kind of disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
Official title: The Association Between Surgical Patient Positions and Perfusion Index
The association between patient positions including supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and perfusion index.
Read the detailed description
Participants are taken to the recovery room and they will wait 15 minutes until measurements. After monitoring the perfusion index using the right ring finger, first the participant will be taken to supine position. The perfusion index value will be obtained after three minutes of measurement. Second, the position will change to 45 degrees back up sitting position and the measurement will be repeated. Then the participant will be taken to Trendelenburg position, reverse Trendelenburg position, prone, 45 degrees legs lifted supine position respectively, and same measurement will perform.
- Conditions
- Perfusion
- Being tested
- Perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion indexOther
supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position.
| Study group | Role | What they receive |
|---|---|---|
| Patient position | Perfusion index Receives: Other: Perfusion index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index
Perfusion
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start10 May 2017
- Primary completion2 Jul 2017
- Study completion5 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerfusionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Assistan professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121443
- Sponsor's protocol ID
- 17-KAEK-2017
- Status last verified
- May 2017
- First submitted
- 17 Apr 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Surgical Patient Positions and Perfusion Index
- ClinicalTrials.gov ID
- NCT03121443
- Acronym / sponsor ID
- 17-KAEK-2017
- Conditions
- Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 2 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 20 Apr 2017 (actual)
- 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.
The association between patient positions including supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position and perfusion index.
Detailed description
Participants are taken to the recovery room and they will wait 15 minutes until measurements. After monitoring the perfusion index using the right ring finger, first the participant will be taken to supine position. The perfusion index value will be obtained after three minutes of measurement. Second, the position will change to 45 degrees back up sitting position and the measurement will be repeated. Then the participant will be taken to Trendelenburg position, reverse Trendelenburg position, prone, 45 degrees legs lifted supine position respectively, and same measurement will perform.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient position | – | Other: Perfusion indexPerfusion index |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers American society of anesthesiologists score of 1
Key inclusion criteria (1 listed)
- American society of anesthesiologists score of 1
Key exclusion criteria (1 listed)
- any kind of disease
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 |
|---|---|---|
| Perfusion indexsupine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position. | Other | Patient position |
Primary outcome
Perfusion index
Time frame: one month
Perfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- 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.
Hakan Tapar principal investigator
Assistan professor
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 Perfusion, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 11 Jul 2017. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perfusion index (time frame: one month). 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 11 Jul 2017.