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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02826889 |
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Date of registration:
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06/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table
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Scientific title:
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Date of first enrolment:
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May 24, 2016 |
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Target sample size:
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58 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02826889 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients between the age of 19 and 75, scheduled for spine surgery under general
anesthesia using the Jackson table
Exclusion Criteria:
1. Patient refusal
2. Patients that are not normal sinus rhythm on preoperative ECG
3. Patients with moderate~severe cardiac valve disease
4. Patients with an ejection fraction under 50%
5. Significant lung disease
6. Obesity (BMI>35kg/m2)
7. Patients with contraindications to esophageal doppler probe insertion
8. Illiterate patients or foreigners
Age minimum:
19 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis
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Spondylolisthesis
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Scoliosis or Tumors
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Spinal Fractures
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Intervention(s)
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Device: Pleth Variability Index (PVI)
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Device: Philips Intelivue MP70 monitor
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Primary Outcome(s)
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Pleth Variability Index (PVI)
[Time Frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position]
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Pulse Pressure Variation (PPV)
[Time Frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position]
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Secondary ID(s)
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4-2016-0189
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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