HypotensionNCT06155461
Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index
An observational study of Hypotension and Geriatric Patients, run by Egymedicalpedia at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Hypotension, Geriatric Patients, Anesthesia
- What is being tested?
- Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 15 Apr 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery under general anesthesia, ASA I, II
Who may be able to join
- 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.
Who cannot join
- Refusal to join the study.
- Mental and psychiatric disorders (un co-operative patients).
- Emergency operations
- ASA physical status > II
- Dyspnea, respiratory distress, un-compensated respiratory disease (generalized wheezes, defective functional capacity, peripheral O2 saturation less than 90% on room air )
- patients with uncontrolled hypertension, Systolic blood pressure ≥ 180 mmHg
Show all 10Show fewer
- IVC non visualized
- Patients with increased intra-abdominal pressure (intra-abdominal mass compressing IVC).
- anticipated or accidental discovered difficult airway
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University hospitals
Cairo
Ismail Abdelgawad, Assist.Prof, 01117310053, ismailmoh000@gmail.com
Ahmed Sedeek, Lecturer
About this study
Official title: Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anesthesia in Geriatric Patients
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
- Conditions
- Hypotension, Geriatric Patients, Anesthesia
- Being tested
- Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter IndexProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the predictive value of pre-induction IVC
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
Measured: 5 minutes
Secondary outcomes (2)
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
Measured: 5 minutes
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Apr 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Saied, Professor, Study chair, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155461
- Sponsor's protocol ID
- Anaesth._0319/2023Med.Research
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anesthesia in Geriatric Patients
- ClinicalTrials.gov ID
- NCT06155461
- Acronym / sponsor ID
- Anaesth._0319/2023Med.Research
- Conditions
- Hypotension, Geriatric Patients, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 4 Dec 2023 (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.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery under general anesthesia, ASA I, II
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Refusal to join the study.
- Mental and psychiatric disorders (un co-operative patients).
- Emergency operations
- ASA physical status > II
- Dyspnea, respiratory distress, un-compensated respiratory disease (generalized wheezes, defective functional capacity, peripheral O2 saturation less than 90% on room air )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Ultrasonographic Evaluation of Caval Aorta Diameter Indexto 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. | Procedure or surgery | – |
Primary outcome
Evaluate the predictive value of pre-induction IVC
Time frame: 5 minutes
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
2 secondary outcomes
Incidence of post-induction hypotension
Time frame: 5 minutes
Correlation between each of IVC collapsibility index with the percentage of the maximum decrease in mean arterial pressure after induction of anesthesia
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Saied, Professor study chair
Al-Azhar University, Faculty of medicine for boys
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 Hypotension and Geriatric Patients, run by Egymedicalpedia 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Al-Bahar, M.D (01116723370, dr.ms.bahar3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the predictive value of pre-induction IVC (time frame: 5 minutes). 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 Dec 2023.