Hypotension on InductionNCT04658576
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension
An observational study of Hypotension on Induction, run by Cairo University at 1 site in Egypt.
Trial summary
Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 23 Oct 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: • Patients scheduled for elective orthopedic surgeries under general anaesthesia
Who may be able to join
- • Adult patients (>18years)
- ASA I-II
Who cannot join
- • ASA physical status > II
- Dyspnea
- Systolic blood pressure ≥ 180 mmHg
- Systolic blood pressure < 90 mmHg
- Agitation (RASS > 1)
- IVC non visualized
Show all 9Show fewer
- Epidural catheter in use
- Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anaesthesia: A Prospective Observational Cohort Study.
Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension
Read the detailed description
This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.
- Conditions
- Hypotension on Induction
What is being measured
The primary outcome is the main question the study is designed to answer.
• Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension
Measurement of pre-operative IVC-AOrta diameter index and IVC collapsibility index
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion23 Oct 2022
- Study completion23 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa Fathy, Cairo University
- Investigators
- Shymaa Fathy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658576
- Sponsor's protocol ID
- MD-245-2020
- Status last verified
- Jul 2023
- First submitted
- 2 Dec 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anaesthesia: A Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT04658576
- Acronym / sponsor ID
- MD-245-2020
- Conditions
- Hypotension on Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 23 Oct 2022 (actual)
- First posted
- 8 Dec 2020 (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.
Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension
Detailed description
This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- • Patients scheduled for elective orthopedic surgeries under general anaesthesia
Key inclusion criteria (2 listed)
- • Adult patients (>18years)
Key exclusion criteria (9 listed)
- • ASA physical status > II
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
• Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension
Time frame: 15 minutes
Measurement of pre-operative IVC-AOrta diameter index and IVC collapsibility index
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 5 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Shymaa Fathy, MD principal investigator
Cairo 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 Hypotension on Induction, run by Cairo 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 2 inclusion and 9 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 5 Jul 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?
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?
• Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension (time frame: 15 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 5 Jul 2023.