Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index

Anesthesia Clinical Trial

Official title:

Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anesthesia in Geriatric Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155461
• Other study ID #: Anaesth._0319/2023Med.Research
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: November 2023
• Source: Egymedicalpedia
• Contact: Mohammad Al-Bahar, M.D
• Phone: 01116723370
• Email: dr.ms.bahar3[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 15, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Anesthesia
• Geriatric Patients
• Hypotension

Intervention

Procedure:
• Preoperative 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.

Locations

Country	Name	City	State
Egypt	Al-Azhar University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the predictive value of pre-induction IVC	Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension	5 minutes
Secondary	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	5 minutes
Secondary	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	5 minutes