Assess the Potential of the IVC Distensibility Index as a Predictor of Postoperative Fluid Status in Children.
Correlation Between Intraoperative Fluid Volume and Postoperative Inferior Vena Cava Distensibility Index in Pediatric Operations
Study Overview
Status
Detailed Description
Preoperative settings:
Preoperative assessment will be done which includes Medical History and Clinical Examination: Age, gender, and weight will be recorded, Number of fasting hours, Surgical History documentation of previous surgeries, if any, including details on anesthetic techniques. family history of cardiovascular, renal, or fluid balance disorders. Information on any known allergies, particularly to medications, as well as a list of current medications being taken by the patient. Any coexisting medical conditions, particularly autoimmune, inflammatory, or chronic diseases, will be documented (e.g., asthma, diabetes, renal insufficiency).
Specific Examination for IVC Distensibility:
• Ultrasonographic Examination: Preoperative ultrasound will be used to measure the baseline Inferior Vena Cava (IVC) diameter and assess its distensibility as a part of the preoperative evaluation.
Preoperative Assessment of Fluid Balance:
• Laboratory Tests: Baseline blood tests, including complete blood count, serum electrolytes, and renal function tests, will be performed to assess overall fluid and electrolyte balance.
Intraoperative Monitoring:
Intraoperative fluid strategy will be followed with the local protocol 10 ml/kg/h will be given, and additional boluses 10-20 ml/kg if needed (in case of hemodynamic instability, increasing lactate), losses will be compensated with fluid or blood (if exceeded the allowable blood loss).
This fluid regimen is individualized by the attending anaesthesiologist according to the actual requirement, The volume of fluids administered intraoperatively will be meticulously recorded. Urine Output Documentation of baseline urine output as an indicator of renal function and fluid status.
Postoperative Settings:
All ultrasonographic measurments of IVC will be performed at the end of surgery, before extubation (patient is anaesthetized and completely relaxed, in the supine position, PEEP less than 7 cmH2O and tidal volume 6-8 ml/kg The probe will be placed at the sub xiphoid area and measurements will be obtained in M-mode imaging performed 2 to 3 cm distal to the right atrium in the long-axis subcostal view..IVC diameter during inspiration (IVCi) and expiration (IVCe) will be measured, Collapsibility index (CI) measured as difference between IVCe, IVCi divided on IVCe (CI = IVCe - IVCi /IVCe x100).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt, 11111
- Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatric patients aged 1-12 years.
- ASA status I - II
- Patients undergoing elective surgical procedures requiring general anesthesia.
Exclusion Criteria:
Patients with known congenital heart disease, valvular heart disease or Pulmonary hypertension
- Renal disorders (Acute or Chronic).
- PEEP more than 7 cmH2O at time of assessment of IVC distensibility index
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1: Age 1-4 years, Conservative Fluid
Patients aged 1 to 4 years receiving intraoperative fluid <10 ml/kg/h.
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Group 2: Age 1-4 years, Liberal Fluid
Patients aged 1 to 4 years receiving intraoperative fluid ≥10 ml/kg/h.
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Group 3: Age 4-8 years, Conservative Fluid
Patients aged 4 to 8 years receiving intraoperative fluid <10 ml/kg/h.
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Group 4: Age 4-8 years, Liberal Fluid
Patients aged 4 to 8 years receiving intraoperative fluid ≥10 ml/kg/h.
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Group 5: Age 8-12 years, Conservative Fluid
Patients aged 8 to 12 years receiving intraoperative fluid <10 ml/kg/h.
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Group 6: Age 8-12 years, Liberal Fluid
Patients aged 8 to 12 years receiving intraoperative fluid ≥10 ml/kg/h.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Inferior Vena Cava distensibility index
Time Frame: At the end of surgery, before extubation
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All ultrasonographic measurments of IVC will be performed at the end of surgery, before extubation (patient is anaesthetized and completely relaxed, in the supine position, PEEP less than 7 cmH2O and tidal volume 6-8 ml/kg The probe will be placed at the sub xiphoid area and measurements will be obtained in M-mode imaging performed 2 to 3 cm distal to the right atrium in the long-axis subcostal view..IVC diameter during inspiration (IVCi) and expiration (IVCe) will be measured, Collapsibility index (CI) measured as difference between IVCe, IVCi divided on IVCe (CI = IVCe - IVCi /IVCe x100).
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At the end of surgery, before extubation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rawan Abu Deif, M.B.B.CH, Anaesthesia resident Ain Shams University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMASU MS 728/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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