Post Spinal Anaesthesia HypotensionNCT06767033
Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
An observational study of Post Spinal Anaesthesia Hypotension and Inferior Vena Cava Collapsibility Index, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Anaesthesia Hypotension, Inferior Vena Cava Collapsibility Index
- What is being tested?
- Ultrasound Guided Inferior Vena Cava Collapsibility Index Assessment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2024to 1 Sep 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
Who may be able to join
- Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
- Both Sexes.
- Aged 30 to 60 years.
- Body mass index <35 kg/m2
Who cannot join
- Patients' refusal of procedure or participation in the study.
- Patients with contraindication to spinal anaesthesia.
- Patients with severe cardiovascular or pulmonary disease.
- Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.
Read the detailed description
Prospective Cohort Study conducted in Ain Shams University Hospitals.
- Being tested
- Ultrasound Guided Inferior Vena Cava Collapsibility Index Assessment
- Keywords
- Inferior Vena Cava Collapsibility Index, Post Spinal Anaesthesia Hypotension, Arthroscopic Knee Surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Inferior Vena Cava Collapsibility Index AssessmentDevice
Before spinal anaesthesia, inferior vena cava collapsibility index was measured for all patients using Ultrasound device.
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.
Measured: 6 months
Secondary outcomes (1)
to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start22 Feb 2024
- Primary completion22 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anaesthesia 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767033
- Sponsor's protocol ID
- FMASU MS89/2024
- Status last verified
- Sep 2024
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
- ClinicalTrials.gov ID
- NCT06767033
- Acronym / sponsor ID
- FMASU MS89/2024
- Keywords
- Inferior Vena Cava Collapsibility Index, Post Spinal Anaesthesia Hypotension, Arthroscopic Knee Surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 9 Jan 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 aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.
Detailed description
Prospective Cohort Study conducted in Ain Shams University Hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
Key inclusion criteria (4 listed)
- Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
- Both Sexes.
- Aged 30 to 60 years.
- Body mass index <35 kg/m2
Key exclusion criteria (4 listed)
- Patients' refusal of procedure or participation in the study.
- Patients with contraindication to spinal anaesthesia.
- Patients with severe cardiovascular or pulmonary disease.
- Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
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 |
|---|---|---|
| Ultrasound Guided Inferior Vena Cava Collapsibility Index AssessmentBefore spinal anaesthesia, inferior vena cava collapsibility index was measured for all patients using Ultrasound device. | Device | – |
Primary outcome
to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.
Time frame: 6 months
1 secondary outcome
to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension
Time frame: 6 months
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 9 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Post Spinal Anaesthesia Hypotension and Inferior Vena Cava Collapsibility Index, 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 4 inclusion and 4 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 9 Jan 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?
to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension. (time frame: 6 months). 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 9 Jan 2025.