ClinicalTrials.gg
Status unknownNCT06155461Updated Dec 4, 2023

Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index

An observational study in Hypotension, Geriatric Patients and Anesthesia, sponsored by Egymedicalpedia. Status unknown at 1 site in Egypt. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-04.

Sponsored by Egymedicalpedia · Observational

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
105
Ages
60 Years to 85 Years
Sex
All
01

Study summary

General anesthesia is frequently used in daily clinical practice. Elderly patients often require a higher level of care than younger patients during the perioperative period, with higher health care costs.

Strategies to optimize anesthesia care to reduce complications and improve outcomes in elderly surgical patients will also be of great value to the individual patients and society.

Read the detailed description

Prevention of an undesired hypotensive event has a key role in providing patient safety. Patients' susceptibility to intra-operative hypotension can be influenced by the pre-operative volume status.

Despite worldwide improvement in preoperative optimization and changing practices, promoting the avoidance of unnecessary fasting and mechanical bowel preparation, optimized fluid therapy remains the cornerstone of treatment with excellent effectiveness.

The earlier, non-invasive and bedside investigation for assessment of volume status will enhance the effective prevention and management of post-induction hypotension and hence better clinical outcome .

Several methodologies have been tried with a specific goal to predict post-induction hypotension, including heart rate variability (HRV), passive leg raise test and perfusion index.

Despite this, assessing intravascular volume status is still challenging matter. Therefore, the aim of this study will be to compare between the collapsibility index of the inferior vena cava (IVCCI) and IVC to aorta diameter index (IVCD: AoD index) as a potential screening tool to identify patients who are vulnerable to hypotensive events related to general anesthesia.

IVCCI has been tested before in several studies as a predictor of post-induction hypotension. However, IVCD: AoD index has not been investigated before for prediction of hypotension after induction of general anesthesia in elderly. Among the earliest studies to assess the IVCD: AoD index was carried out by Kodiak et al., in hypovolemic patients.

Additionally, it has been investigated for predicting the postspinal anesthesia hypotension and showed promising results

02

Conditions studied

  • Hypotension
  • Geriatric Patients
  • Anesthesia

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03

In context

Hypotension

1,021 studies on the registry are indexed under Hypotension; 172 are open to participants now.

This study's planned enrollment of 105 is above the median of 84 across 301 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing elective surgery under general anesthesia, ASA I, II

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients ( 60 - 85 ) years old of both sexes with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for elective surgeries under general anesthesia.

Exclusion criteria

Exclusion Criteria:

  1. Refusal to join the study.
  2. Mental and psychiatric disorders (un co-operative patients).
  3. Emergency operations
  4. ASA physical status > II
  5. Dyspnea, respiratory distress, un-compensated respiratory disease (generalized wheezes, defective functional capacity, peripheral O2 saturation less than 90% on room air )
  6. patients with uncontrolled hypertension, Systolic blood pressure ≥ 180 mmHg
  7. IVC non visualized
  8. Patients with increased intra-abdominal pressure (intra-abdominal mass compressing IVC).
  9. anticipated or accidental discovered difficult airway
  10. patients taking angiotensin converting enzyme inhibitors or angiotensin receptors blockers, documented heart failure, elevated pulmonary arterial pressure > 40 mmHg, significant valvular heart disease, significant carotid stenosis, peripheral vascular diseases, unstable angina or cardiac ejection fraction less than 40%, implanted pacemaker or cardioversion , known cases of abdominal aortic abnormality as aneurysm or previous operations.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
105 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePreoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index

    to evaluate the ability of preoperative ultrasound measurements of IVC to aorta diameter index and the inferior vena cava collapsibility index (IVCCI) for predicting post induction hypotension after general anesthesia in geriatric patients.

06

What researchers measure

Primary outcomes

  1. Evaluate the predictive value of pre-induction IVC

    Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension

    Time frame: 5 minutes

Secondary outcomes

  1. Incidence of post-induction hypotension

    Correlation between each of maximum aortic diameter with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia

    Time frame: 5 minutes

  2. Correlation between each of IVC collapsibility index with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia

    Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
  • Al-Azhar University hospitals
    Cairo, Egypt
    • Ismail Abdelgawad, Assist.Prof · Contact · ismailmoh000@gmail.com · 01117310053
    • Ahmed Sedeek, Lecturer · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2023 (actual). Primary completion is estimated for Apr 2024, 12 months after the start.

Of 177 observational studies under Hypotension, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's planned 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 19, 2023
First posted
Dec 4, 2023
StartActual
Apr 1, 2023
Primary completionEst.
Apr 1, 2024
CompletionEst.
Apr 15, 2024
Last update
Dec 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06155461
Lead sponsor
Egymedicalpedia
Responsible party
Sponsor
First posted
Dec 4, 2023
Start date
Apr 1, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 15, 2024 (estimated)
Last update
Dec 4, 2023

Study contacts

Mohammad Al-Bahar, M.D
Contact
dr.ms.bahar3@gmail.com
01116723370
Ahmed Saied, Professor
study chair · Al-Azhar University, Faculty of medicine for boys

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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