<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984956</url>
  </required_header>
  <id_info>
    <org_study_id>ERZINCAN UNIVERSITY 4</org_study_id>
    <nct_id>NCT02984956</nct_id>
  </id_info>
  <brief_title>Pleth Variability Index and Hypotension</brief_title>
  <official_title>Hypotension Relationship With Pleth Variability Index In Hip Fracture Patients Who Underwent Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erzincan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erzincan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Correct assessment of a patient's volume status is the most important goal for an&#xD;
      anesthetist. However, most of the variables used for fluid response evaluation are invasive&#xD;
      and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used&#xD;
      monitoring method in many countries. Our aim in this study is to investigate the usefulness&#xD;
      of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture&#xD;
      patients who underwent spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detecting pleth variability index-hypotension relationship</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>pleth variability index response to fluid management</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Make a differential diagnosis of hypotension with pleth variability index</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between arterial hemoglobin and pleth variability index hemoglobin</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hypotension</condition>
  <condition>Pleth Variability Index</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pleth variability index</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent spinal anesthesia for hip fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 65 years old&#xD;
&#xD;
          -  Patients to undergo spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 65 years old&#xD;
&#xD;
          -  Patients to undergo general anesthesia or only sedation&#xD;
&#xD;
          -  Patients with cardiac arrhythmia&#xD;
&#xD;
          -  Patients with low ventricular ejection fraction&#xD;
&#xD;
          -  Heart valve disease patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Erzincan University</name>
      <address>
        <city>Erzincan</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kumar A, Anel R, Bunnell E, Habet K, Zanotti S, Marshall S, Neumann A, Ali A, Cheang M, Kavinsky C, Parrillo JE. Pulmonary artery occlusion pressure and central venous pressure fail to predict ventricular filling volume, cardiac performance, or the response to volume infusion in normal subjects. Crit Care Med. 2004 Mar;32(3):691-9. doi: 10.1097/01.ccm.0000114996.68110.c9.</citation>
    <PMID>15090949</PMID>
  </reference>
  <reference>
    <citation>Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.</citation>
    <PMID>17080001</PMID>
  </reference>
  <reference>
    <citation>Preisman S, Kogan S, Berkenstadt H, Perel A. Predicting fluid responsiveness in patients undergoing cardiac surgery: functional haemodynamic parameters including the Respiratory Systolic Variation Test and static preload indicators. Br J Anaesth. 2005 Dec;95(6):746-55. doi: 10.1093/bja/aei262.</citation>
    <PMID>16286349</PMID>
  </reference>
  <reference>
    <citation>Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.</citation>
    <PMID>18522935</PMID>
  </reference>
  <reference>
    <citation>Derichard A, Robin E, Tavernier B, Costecalde M, Fleyfel M, Onimus J, Lebuffe G, Chambon JP, Vallet B. Automated pulse pressure and stroke volume variations from radial artery: evaluation during major abdominal surgery. Br J Anaesth. 2009 Nov;103(5):678-84. doi: 10.1093/bja/aep267. Epub 2009 Sep 29.</citation>
    <PMID>19797246</PMID>
  </reference>
  <reference>
    <citation>Solus-Biguenet H, Fleyfel M, Tavernier B, Kipnis E, Onimus J, Robin E, Lebuffe G, Decoene C, Pruvot FR, Vallet B. Non-invasive prediction of fluid responsiveness during major hepatic surgery. Br J Anaesth. 2006 Dec;97(6):808-16. doi: 10.1093/bja/ael250. Epub 2006 Sep 16.</citation>
    <PMID>16980709</PMID>
  </reference>
  <reference>
    <citation>Cannesson M, Delannoy B, Morand A, Rosamel P, Attof Y, Bastien O, Lehot JJ. Does the Pleth variability index indicate the respiratory-induced variation in the plethysmogram and arterial pressure waveforms? Anesth Analg. 2008 Apr;106(4):1189-94, table of contents. doi: 10.1213/ane.0b013e318167ab1f.</citation>
    <PMID>18349191</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20035228</PMID>
  </reference>
  <reference>
    <citation>Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.</citation>
    <PMID>20705785</PMID>
  </reference>
  <reference>
    <citation>Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. The ability of pleth variability index to predict the hemodynamic effects of positive end-expiratory pressure in mechanically ventilated patients under general anesthesia. Anesth Analg. 2010 Mar 1;110(3):792-8. doi: 10.1213/ANE.0b013e3181cd6d06.</citation>
    <PMID>20185658</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erzincan University</investigator_affiliation>
    <investigator_full_name>ILKE KUPELI</investigator_full_name>
    <investigator_title>assist. prof.</investigator_title>
  </responsible_party>
  <keyword>Hypotension</keyword>
  <keyword>Pleth variability index</keyword>
  <keyword>Hip Fracture</keyword>
  <keyword>Spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984956
org study id: ERZINCAN UNIVERSITY 4
nct id: NCT02984956
lead sponsor: 
has dmc: No
Correct assessment of a patient's volume status is the most important goal for an
      anesthetist. However, most of the variables used for fluid response evaluation are invasive
      and technically challenging.Pulse oximeter is a non-invasive, standardized and widely used
      monitoring method in many countries. Our aim in this study is to investigate the usefulness
      of the noninvasive pleth variability index to predict hypotension in orthopedic hip fracture
      patients who underwent spinal anesthesia.
observational model: Cohort
time perspective: Prospective
measure: Detecting pleth variability index-hypotension relationship
time frame: one year
measure: pleth variability index response to fluid management
time frame: one year
measure: Make a differential diagnosis of hypotension with pleth variability index
time frame: one year
measure: Correlation between arterial hemoglobin and pleth variability index hemoglobin
time frame: one year
intervention type: Device
intervention name: pleth variability index
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
citation: Kumar A, Anel R, Bunnell E, Habet K, Zanotti S, Marshall S, Neumann A, Ali A, Cheang M, Kavinsky C, Parrillo JE. Pulmonary artery occlusion pressure and central venous pressure fail to predict ventricular filling volume, cardiac performance, or the response to volume infusion in normal subjects. Crit Care Med. 2004 Mar;32(3):691-9. doi: 10.1097/01.ccm.0000114996.68110.c9.
PMID: 15090949
citation: Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
PMID: 17080001
citation: Preisman S, Kogan S, Berkenstadt H, Perel A. Predicting fluid responsiveness in patients undergoing cardiac surgery: functional haemodynamic parameters including the Respiratory Systolic Variation Test and static preload indicators. Br J Anaesth. 2005 Dec;95(6):746-55. doi: 10.1093/bja/aei262.
PMID: 16286349
citation: Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
PMID: 18522935
citation: Derichard A, Robin E, Tavernier B, Costecalde M, Fleyfel M, Onimus J, Lebuffe G, Chambon JP, Vallet B. Automated pulse pressure and stroke volume variations from radial artery: evaluation during major abdominal surgery. Br J Anaesth. 2009 Nov;103(5):678-84. doi: 10.1093/bja/aep267. Epub 2009 Sep 29.
PMID: 19797246
citation: Solus-Biguenet H, Fleyfel M, Tavernier B, Kipnis E, Onimus J, Robin E, Lebuffe G, Decoene C, Pruvot FR, Vallet B. Non-invasive prediction of fluid responsiveness during major hepatic surgery. Br J Anaesth. 2006 Dec;97(6):808-16. doi: 10.1093/bja/ael250. Epub 2006 Sep 16.
PMID: 16980709
citation: Cannesson M, Delannoy B, Morand A, Rosamel P, Attof Y, Bastien O, Lehot JJ. Does the Pleth variability index indicate the respiratory-induced variation in the plethysmogram and arterial pressure waveforms? Anesth Analg. 2008 Apr;106(4):1189-94, table of contents. doi: 10.1213/ane.0b013e318167ab1f.
PMID: 18349191
citation: 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.
PMID: 20035228
citation: Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
PMID: 20705785
citation: Desebbe O, Boucau C, Farhat F, Bastien O, Lehot JJ, Cannesson M. The ability of pleth variability index to predict the hemodynamic effects of positive end-expiratory pressure in mechanically ventilated patients under general anesthesia. Anesth Analg. 2010 Mar 1;110(3):792-8. doi: 10.1213/ANE.0b013e3181cd6d06.
PMID: 20185658
responsible party type: Principal Investigator
investigator affiliation: Erzincan University
investigator full name: ILKE KUPELI
investigator title: assist. prof.
mesh term: Hypotension
sharing ipd: No