Perfusion IndexNCT06742619
PERFUSION INDEX, PRONE ,SUPİNE AND SITTING POSITION
An observational study of Perfusion Index, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
The aim was to investigate the effect of anesthesia management on perfusion index changes in obese patients and different anesthesia positions. The effect of positional intra-abdominal pressure and lung-related variables was investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Perfusion Index
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Feb 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will be operated in supine prone and sitting positions
Who may be able to join
- 18-70 years range
- Patients who will be operated in supine prone and sitting positions
Who cannot join
- Heart Failure
- antiarrhythmic drug use hemodynamic instability uncooperative patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OBESE PATIENTS AND ANAESTHESİA İNDUCTİON: PERFUSION INDEX, PRONE ,SUPİNE AND SITTING POSITION
The aim was to investigate the effect of anesthesia management on perfusion index changes in obese patients and different anesthesia positions. The effect of positional intra-abdominal pressure and lung-related variables was investigated.
Read the detailed description
There may be changes in haemodynamic findings in patients after anaesthesia. The most common of these are hypotension and bradycardia. Many factors play a role on the hypotensive effect of anaesthesia induction1 . Position changes in patients during surgery in obese patients affect these changes.In our study, the changes in haemodimaic findings and the changes in PI and PVI were investigated in patients with BMI 30 and above and in patients with BMI within normal limits after induction of anaesthesia by giving prone position and sitting position.Position changes in patients during surgery in obese patients affect these changes. Hypertension and hypotension after induction of anaesthesia are common in obese patients. In addition, decreased venous return to the heart due to increased intrathoracic pressure during mechanical ventilation may trigger bradycardia and hypotension.
- Conditions
- Perfusion Index
- Keywords
- perfusion index, prone, supine, anesthesia
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gruops | patient supine position | |
| groupp | patient prone position | |
| grupsitting | patient sitting position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group P-S-ST
Comparison after anesthesia induction in prone, supine and sitting positions.(Perfusion index value)
Measured: preoperative 5 minute and after anesthesia induction 10 20 30. mimute Perfusion İndex value)
Secondary outcomes (1)
Body mass index, age,comorbidities
in preoperative period patiens body mass index (kg/m2), age (years) and comorbidities were recorded
Measured: preoperative perion (10 minutes before anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perfusion IndexStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742619
- Sponsor's protocol ID
- u1103
- Status last verified
- Dec 2024
- First submitted
- 18 Nov 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Many studies can be done due to sharing
Publications
Hara K, Ichihara K, Yamaguchi M, Takeshita H, Kuroki T. Effect of intraoperative operating table rotation on lower limb perfusion index in patients in the lithotomy position. Medicine (Baltimore). 2022 Sep 23;101(38):e30412. doi: 10.1097/MD.0000000000030677.
PubMed 36197219
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBESE PATIENTS AND ANAESTHESİA İNDUCTİON: PERFUSION INDEX, PRONE ,SUPİNE AND SITTING POSITION
- ClinicalTrials.gov ID
- NCT06742619
- Acronym / sponsor ID
- u1103
- Conditions
- Perfusion Index
- Keywords
- perfusion index, prone, supine, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 19 Dec 2024 (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 aim was to investigate the effect of anesthesia management on perfusion index changes in obese patients and different anesthesia positions. The effect of positional intra-abdominal pressure and lung-related variables was investigated.
Detailed description
There may be changes in haemodynamic findings in patients after anaesthesia. The most common of these are hypotension and bradycardia. Many factors play a role on the hypotensive effect of anaesthesia induction1 . Position changes in patients during surgery in obese patients affect these changes.In our study, the changes in haemodimaic findings and the changes in PI and PVI were investigated in patients with BMI 30 and above and in patients with BMI within normal limits after induction of anaesthesia by giving prone position and sitting position.Position changes in patients during surgery in obese patients affect these changes. Hypertension and hypotension after induction of anaesthesia are common in obese patients. In addition, decreased venous return to the heart due to increased intrathoracic pressure during mechanical ventilation may trigger bradycardia and hypotension.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gruops | – | –patient supine position |
| groupp | – | –patient prone position |
| grupsitting | – | –patient sitting position |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be operated in supine prone and sitting positions
Key inclusion criteria (2 listed)
- 18-70 years range
- Patients who will be operated in supine prone and sitting positions
Key exclusion criteria (2 listed)
- Heart Failure
- antiarrhythmic drug use hemodynamic instability uncooperative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Group P-S-ST
Time frame: preoperative 5 minute and after anesthesia induction 10 20 30. mimute Perfusion İndex value)
Comparison after anesthesia induction in prone, supine and sitting positions.(Perfusion index value)
1 secondary outcome
Body mass index, age,comorbidities
Time frame: preoperative perion (10 minutes before anesthesia)
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 19 Dec 2024.
- Results publication: PubMed 36197219Hara K, Ichihara K, Yamaguchi M, Takeshita H, Kuroki T. Effect of intraoperative operating table rotation on lower limb perfusion index in patients in the lithotomy position. Medicine (Baltimore). 2022 Sep 23;101(38):e30412. doi: 10.1097/MD.0000000000030677.
- Individual participant dataSharing planned: Undecided. Many studies can be done due to sharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Index, run by Amasya 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 2 inclusion and 2 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 19 Dec 2024. 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?
Group P-S-ST (time frame: preoperative 5 minute and after anesthesia induction 10 20 30. mimute Perfusion İndex value)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06742619, which also lists 1 linked publication.
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 19 Dec 2024.