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出境医 / 临床实验 / Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?

Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?

Study Description
Brief Summary:
Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.

Condition or disease
Cesarean Section Complications Hypotension Spinal Anesthesia Perfusion Index Pleth Variability Index

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : July 11, 2019
Actual Study Completion Date : July 11, 2019
Arms and Interventions
Group/Cohort
Hypotension group
Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure drop below 80 mmHg or have symptoms of hypotension such as dizziness, nausea and vomiting during the procedure.
Non-hypotension group
Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure does not drop below 80 mmHg or have any symptoms of hypotension during the procedure.
Outcome Measures
Primary Outcome Measures :
  1. pleth variability index (PVI) [ Time Frame: perioperative ]
    PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.

  2. Perfusion index (PI) [ Time Frame: perioperative ]
    PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.


Secondary Outcome Measures :
  1. blood pressure (mmHg) [ Time Frame: perioperative ]
    blood pressure will be recorded


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Criteria

Inclusion Criteria:

  • singleton parturient
  • planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

  • gestational age < 36 weeks

    • emergency cases
    • placenta previa, pre-eclampsia
    • BMI>40
    • Reynauld disease
    • patient refusal
    • cardiovascular disease
Contacts and Locations

Locations
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Turkey
Kahramanmaras Sutcu Imam University
Kahramanmaras, In The USA Or Canada, Please Select..., Turkey, 46100
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Study Director: MAHMUT ARSLAN KSU school of medicine
Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 20, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date May 21, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2019)
  • pleth variability index (PVI) [ Time Frame: perioperative ]
    PVI values (%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
  • Perfusion index (PI) [ Time Frame: perioperative ]
    PI values(%)at supine and lateral positions, before and after spinal anesthesia will be recorded and compared between the 2 groups.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2019)
blood pressure (mmHg) [ Time Frame: perioperative ]
blood pressure will be recorded
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Can Right Toe Perfusion Index or Pleth Variability Index Predict Spinal Anesthesia Induced Hypotension?
Official Title Can we Predict Predict Spinal Anesthesia Induced Hypotension During Caesarean Section Using Right Toe Perfusion Index or Pleth Variability Index?
Brief Summary Spinal anesthesia for caesarean section is associated with a decrease in systemic vascular resistance and cardiac output and may cause hypotension in a significant portion of the parturients. Hypotension during delivery may cause maternal and fetal complications. If parturients who are likely to develop hypotension after spinal anesthesia can be identified before surgery, anesthesiologists would have opportunity to take measures such as prophylactic vasopressor administration. Perfusion index (PI) measured by pulse oximetry reflects vasomotor tone which affects the degree of hypotension after spinal anesthesia. This is a non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ratio of pulsatile versus the non-pulsatile component of the blood flow. A lower PI indicates greater peripheral vasomotor tone. Pleth variability index (PVI) is calculated using maximum and minimum values of perfusion index during respiratory cycles. PVI is one of the dynamic indices that can predict fluid responsiveness. There are several studies investigating the predictive value of finger PI and PVI on hypotension after spinal anesthesia. However the aortocaval compression by the gravid uterus directly effects the lower extremity perfusion. So, in this study we aimed to investigate whether the right toe PI and PVI values at supine and left lateral positions can predict hypotension during caesarean section.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Parturients scheduled for elective low segment caesarean section under spinal anesthesia
Condition
  • Cesarean Section Complications
  • Hypotension
  • Spinal Anesthesia
  • Perfusion Index
  • Pleth Variability Index
Intervention Not Provided
Study Groups/Cohorts
  • Hypotension group
    Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure drop below 80 mmHg or have symptoms of hypotension such as dizziness, nausea and vomiting during the procedure.
  • Non-hypotension group
    Parturients undergoing elective C/S under spinal anesthesia whose systolic arterial pressure does not drop below 80 mmHg or have any symptoms of hypotension during the procedure.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2019)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date July 11, 2019
Actual Primary Completion Date July 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • singleton parturient
  • planned for elective LSCS under spinal anesthesia

Exclusion Criteria:

  • gestational age < 36 weeks

    • emergency cases
    • placenta previa, pre-eclampsia
    • BMI>40
    • Reynauld disease
    • patient refusal
    • cardiovascular disease
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03956186
Other Study ID Numbers KSU 2019-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
Study Sponsor Kahramanmaras Sutcu Imam University
Collaborators Not Provided
Investigators
Study Director: MAHMUT ARSLAN KSU school of medicine
PRS Account Kahramanmaras Sutcu Imam University
Verification Date July 2019