Intraoperative Fluid VolumeNCT06957171
Assess the Potential of the IVC Distensibility Index as a Predictor of Postoperative Fluid Status in Children.
An observational study of Intraoperative Fluid Volume and Inferior Vena Cava Diameter, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators will assess the relationship between the amount of fluid administered during pediatric surgery and the subsequent IVC distensibility index postoperatively. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Fluid Volume, Inferior Vena Cava Diameter
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 31 Aug 2024
- 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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will include pediatric patients aged 1-12 years undergoing elective surgery under general anesthesia.
Who may be able to join
- Pediatric patients aged 1-12 years.
- ASA status I - II
- Patients undergoing elective surgical procedures requiring general anesthesia.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Intraoperative Fluid Volume and Postoperative Inferior Vena Cava Distensibility Index in Pediatric Operations
The investigators will assess the relationship between the amount of fluid administered during pediatric surgery and the subsequent IVC distensibility index postoperatively.
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Age 1-4 years, Conservative Fluid | Patients aged 1 to 4 years receiving intraoperative fluid <10 ml/kg/h. | |
| Group 2: Age 1-4 years, Liberal Fluid | Patients aged 1 to 4 years receiving intraoperative fluid ≥10 ml/kg/h. | |
| Group 3: Age 4-8 years, Conservative Fluid | Patients aged 4 to 8 years receiving intraoperative fluid <10 ml/kg/h. | |
| Group 4: Age 4-8 years, Liberal Fluid | Patients aged 4 to 8 years receiving intraoperative fluid ≥10 ml/kg/h. | |
| Group 5: Age 8-12 years, Conservative Fluid | Patients aged 8 to 12 years receiving intraoperative fluid <10 ml/kg/h. | |
| Group 6: Age 8-12 years, Liberal Fluid | Patients aged 8 to 12 years receiving intraoperative fluid ≥10 ml/kg/h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior Vena Cava distensibility index
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).
Measured: At the end of surgery, before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Apr 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Fluid VolumeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rawan Abu Deif, M.B.B.CH, Principal investigator, Anaesthesia resident Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957171
- Sponsor's protocol ID
- FMASU MS 728/2024
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intraoperative Fluid Volume and Postoperative Inferior Vena Cava Distensibility Index in Pediatric Operations
- ClinicalTrials.gov ID
- NCT06957171
- Acronym / sponsor ID
- FMASU MS 728/2024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will assess the relationship between the amount of fluid administered during pediatric surgery and the subsequent IVC distensibility index postoperatively.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: Age 1-4 years, Conservative Fluid | – | –Patients aged 1 to 4 years receiving intraoperative fluid <10 ml/kg/h. |
| Group 2: Age 1-4 years, Liberal Fluid | – | –Patients aged 1 to 4 years receiving intraoperative fluid ≥10 ml/kg/h. |
| Group 3: Age 4-8 years, Conservative Fluid | – | –Patients aged 4 to 8 years receiving intraoperative fluid <10 ml/kg/h. |
| Group 4: Age 4-8 years, Liberal Fluid | – | –Patients aged 4 to 8 years receiving intraoperative fluid ≥10 ml/kg/h. |
| Group 5: Age 8-12 years, Conservative Fluid | – | –Patients aged 8 to 12 years receiving intraoperative fluid <10 ml/kg/h. |
| Group 6: Age 8-12 years, Liberal Fluid | – | –Patients aged 8 to 12 years receiving intraoperative fluid ≥10 ml/kg/h. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will include pediatric patients aged 1-12 years undergoing elective surgery under general anesthesia.
Key inclusion criteria (3 listed)
- Pediatric patients aged 1-12 years.
- ASA status I - II
- Patients undergoing elective surgical procedures requiring general anesthesia.
Key exclusion criteria (3 listed)
- Patients with known congenital heart disease, valvular heart disease or Pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inferior Vena Cava distensibility index
Time frame: At the end of surgery, before extubation
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rawan Abu Deif, M.B.B.CH principal investigator
Anaesthesia resident Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Fluid Volume and Inferior Vena Cava Diameter, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inferior Vena Cava distensibility index (time frame: At the end of surgery, before extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2025.