AzTrials
AzTrials

Hemodynamic MonitoringNCT03009669

The Application of Pleth Variability Index in Continuous Monitoring the Volume Status of Intraoperative Patients

An observational study of Hemodynamic Monitoring, run by First Affiliated Hospital, Sun Yat-Sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hemodynamic Monitoring
How many people
50 participants
Where
No sites listed yet
Study dates
Dec 2016to Sep 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ,aged 18-65 years,BMI 18~30kg/㎡.

Who may be able to join

  • patients undergoing elective intestinal tumor surgery
  • American Society of Anesthesiologists (ASA) physical status of grade I-Ⅲ
  • Aged 18-65 years
  • BMI 18~30kg/㎡

Who cannot join

  • Patients under 18 years or above 65 years
  • patients with severe aortic regurgitation
  • patients with permanent cardiac arrhythmias
  • patients with intra-aortic balloon pump
  • patients with severe pulmonary disease
  • patients undergoing emergency surgery

About this study

Official title: The Application of Pleth Variability Index in Continuous Monitoring Volume Status in Patients Undergoing Intestinal Tumor Surgery

To assess the value of using pleth variability index(PVI) to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and PVI and their correlation in patients undergoing intestinal tumor surgeries.

Read the detailed description

Objective: To assess the value of using PVI to monitor the patient's intra-operative volume status continuously by observing the application of stroke volume variation(SVV) and pleth variability index(PVI) and their correlation in patients undergoing intestinal tumor surgeries.

Methods: 50 patients undergoing elective intestinal tumor surgery were enrolled, ASAⅠ-Ⅲ, aged 18-65 years. After the induction of general anesthesia, cardiac index(CI), cardiac output(CO), stroke volume variability(SVV), stroke volume index(SVI) were monitored with Vigileo system, while pleth variability index(PVI) and perfusion index(PI) were monitored with Massion Radical 7 system. During the surgery, goal directed fluid therapy was conducted according to the data of CI、SVI and SVV. Heart rate(HR), mean arterial pressure(MAP), central venous pressure(CVP), CO, CI, SVI, SVV, PI, PVI were recorded while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4). And we calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

Keywords
pleth variability index, stroke volume variation, perfusion Index, intraoperative, intestinal tumor
Medical subject headings
Intestinal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the correlation of SVV and PVI

    SVV and PVI were recorded while after the induction of anesthesia(T1),making surgical incision(T2),performing intestinal anastomosis(T3) and closing the abdominal incision(T4). We calculate the correlation of SVV and PVI using Pearson Correlation Analysis at different time points.

    Measured: during the surgery

Secondary outcomes (5)

  1. stroke volume variability(SVV)

    stroke volume variability(SVV) in percentage.Record the date of SVV while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVV between the time points.

    Measured: during the surgery

  2. pleth variability index(PVI)

    pleth variability index(PVI) in percentage.Record the date of PVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PVI between the time points.

    Measured: during the surgery

  3. pleth index(PI)

    pleth index(PI) in percentage.Record the date of PI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of PI between the time points.

    Measured: during the surgery

  4. cardiac index(CI)

    cardiac index(CI) in L•min-1•m-2.Record the date of CI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of CI between the time points.

    Measured: during the surgery

  5. stroke volume index(SVI)

    (SVI) in ml•m-2.Record the date of SVI while after the induction of anesthesia(T1), making surgical incision(T2), performing intestinal anastomosis(T3) and closing the abdominal incision(T4).Compare the differences of SVI between the time points.

    Measured: during the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionJul 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009669
Sponsor's protocol ID
H20160049（01）
Status last verified
Dec 2016
First submitted
30 Dec 2016
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.

    PubMed 16850777

  • Grocott MPW, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-1106. doi: 10.1213/01.ANE.0000148691.33690.AC.

    PubMed 15781528

  • Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. doi: 10.1097/00000542-200507000-00008.

    PubMed 15983453

  • Strunden MS, Heckel K, Goetz AE, Reuter DA. Perioperative fluid and volume management: physiological basis, tools and strategies. Ann Intensive Care. 2011 Mar 21;1(1):2. doi: 10.1186/2110-5820-1-2.

    PubMed 21906324

  • Samra T, Arya VK. Comparison of cardiac output estimation by FloTrac/Vigileo TM and intermittent pulmonary artery thermodilution in patient with Takayasu arteritis. Ann Card Anaesth. 2011 May-Aug;14(2):163-4. doi: 10.4103/0971-9784.81579. No abstract available.

    PubMed 21636945

  • Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available.

    PubMed 20022261

  • Mathews L, Singh RK. Cardiac output monitoring. Ann Card Anaesth. 2008 Jan-Jun;11(1):56-68. doi: 10.4103/0971-9784.38455.

    PubMed 18182765

  • Cannesson M, Attof Y, Rosamel P, Joseph P, Bastien O, Lehot JJ. Comparison of FloTrac cardiac output monitoring system in patients undergoing coronary artery bypass grafting with pulmonary artery cardiac output measurements. Eur J Anaesthesiol. 2007 Oct;24(10):832-9. doi: 10.1017/S0265021507001056. Epub 2007 Aug 1.

    PubMed 17666154

  • Rex S, Brose S, Metzelder S, Huneke R, Schalte G, Autschbach R, Rossaint R, Buhre W. Prediction of fluid responsiveness in patients during cardiac surgery. Br J Anaesth. 2004 Dec;93(6):782-8. doi: 10.1093/bja/aeh280. Epub 2004 Oct 1.

    PubMed 15465840

  • Michard F, Alaya S, Zarka V, Bahloul M, Richard C, Teboul JL. Global end-diastolic volume as an indicator of cardiac preload in patients with septic shock. Chest. 2003 Nov;124(5):1900-8. doi: 10.1378/chest.124.5.1900.

    PubMed 14605066

  • Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.

    PubMed 20156348

  • Haas S, Trepte C, Hinteregger M, Fahje R, Sill B, Herich L, Reuter DA. Prediction of volume responsiveness using pleth variability index in patients undergoing cardiac surgery after cardiopulmonary bypass. J Anesth. 2012 Oct;26(5):696-701. doi: 10.1007/s00540-012-1410-x. Epub 2012 May 16.

    PubMed 22588287

  • Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.

    PubMed 20035228

  • Desgranges FP, Desebbe O, Ghazouani A, Gilbert K, Keller G, Chiari P, Robin J, Bastien O, Lehot JJ, Cannesson M. Influence of the site of measurement on the ability of plethysmographic variability index to predict fluid responsiveness. Br J Anaesth. 2011 Sep;107(3):329-35. doi: 10.1093/bja/aer165. Epub 2011 Jun 16.

    PubMed 21680600

  • Monnet X, Teboul JL. Volume responsiveness. Curr Opin Crit Care. 2007 Oct;13(5):549-53. doi: 10.1097/MCC.0b013e3282ec68b2.

    PubMed 17762234

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic Monitoring, run by First Affiliated Hospital, Sun Yat-Sen University.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

the correlation of SVV and PVI (time frame: during the surgery). 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 NCT03009669, which also lists 18 linked publications.

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 4 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in