Ultrasound Based IVC IJVNCT05526625
Comparison Of Ultrasound-Based Measures Of Inferior Vena Cava And Internal Jugular Vein For Prediction Of Hypotension During Induction Of General Anesthesia
An observational study of Ultrasound Based IVC IJV, run by Cairo University at 1 site in Egypt.
Trial summary
Hypotension after induction of general anesthesia is a frequent event in routine practice. Even a short period of hypotension may lead to tissue hypoperfusion and predispose to postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Ultrasound Based IVC IJV
- What is being tested?
- Ultrasound-based measurements of IVC & IJV.
- How many people
- 133 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Mar 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients undergoing elective non-cardiac surgery under general anesthesia in Kasr Al-Ainy hospital.
Who may be able to join
- Patients aged 18 - 50 years old
- Any scheduled non-cardiac surgery under general anesthesia
- ASA I, II
Who cannot join
- Patients with major vascular disease
- Unstable angina
- Ejection fraction < 40 %
- Respiratory distress
- Increased intra-abdominal pressure.
- Diabetes mellitus
Show all 9Show fewer
- Implanted pacemaker
- Patients on ACEI or ARB
- Anticipated difficult intubation
Trial locations and contacts
1 site in 1 country.
About this study
Hypotension after induction of general anesthesia is a frequent event in routine practice. Even a short period of hypotension may lead to tissue hypoperfusion and predispose to postoperative complications. Intra-operative hypotension is associated with renal injury, ischemic stroke, myocardial injury and postoperative mortality in patients having non-cardiac surgery under general anesthesia. Underlying hypovolemia is an important and modifiable risk factor for hypotension after anesthetics administration. Ultrasonographic studies of the inferior vena cava (IVC) and the internal jugular vein (IJV) for evaluation of intravascular volume status and prediction of hypotension during induction of general anesthesia have been established.
The present study was designed to compare, on ultrasound-based measures, between inferior vena cava and internal jugular vein for prediction of prolonged hypotension during induction of general anesthesia. The study was conducted at Kasr Al-Ainy hospital, Cairo University in Patients undergoing elective non-cardiac surgery under general anesthesia.
Read the detailed description
Upon arrival to the operating room, routine monitors in the form of pulse oximetry, electrocardiogarm and non-invasive blood pressure monitors were applied. Intravenous line was secured and routine premedications (ranitidine 50 mg and ondansetron 4 mg) were administered.
IVC evaluation was done for the patients in the supine position. The examination was performed after 5 minutes rest. A curved ultrasound transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea) was placed in the subcostal area to visualize the IVC in the paramedian long-axis view. The IVC was visualized using two-dimensional mode as it enters the right atrium; then, pulse wave doppler was used to differentiate the IVC from the aorta. Respiratory variations of the IVC diameter were evaluated using M-mode imaging at medium sweep speed 2 to 3 cm distal to the right atrium. The measures were obtained 3 times and their average was calculated. Maximum and minimum IVC diameters over a single respiratory cycle were used to calculate the collapsibility index as follows:
(dIVCmax- dIVCmin)/dIVCmax Collapsibility index was expressed as a percentage.
IJV measurements were obtained in the supine position using a linear ultrasound transducer (5 - 13 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The probe was placed horizontally at the middle level of the thyroid cartilage. After obtaining a clear transverse view of the right IJV, the IJV area was measured. The measures were repeated after changing the patient's position to the 10° Trendelenburg position. The maximum area of the IJV in the supine and Trendelenburg positions was recorded and the rate of change in IJV area was calculated as follows:
IJV change rate with posture = (IJV area in Trendelenburg position - IJV area in supine position)/(IJV area in Trendelenburg position) All ultrasonographic measurements were performed by a single trained anesthesiologist.
IJV measurements were obtained in the supine position using a linear ultrasound transducer (5 - 13 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The probe was placed horizontally at the middle level of the thyroid cartilage. After obtaining a clear transverse view of the right IJV, the IJV area was measured. The measures were repeated after changing the patient's position to the 10° Trendelenburg position. The maximum area of the IJV in the supine and Trendelenburg positions was recorded and the rate of change in IJV area was calculated as follows:
IJV change rate with posture = (IJV area in Trendelenburg position - IJV area in supine position)/(IJV area in Trendelenburg position) All ultrasonographic measurements were performed by a single trained anesthesiologist.
- Conditions
- Ultrasound Based IVC IJV
- Being tested
- Ultrasound-based measurements of IVC & IJV.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-based measurements of IVC & IJV.Other
Ultrasound-based measurements of IVC \& IJV.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the accuracy of IVC and IJV variations in prediction of prolonged post-induction hypotension.
Comparison of the accuracy (area under receiver operating characteristic curves) of IVC and IJV variations in prediction of prolonged post-induction hypotension (defined as MBP < 80% of the baseline reading for 2 minutes or more).
Measured: Intra-operative along the time of the study
Secondary outcomes (8)
Incidence of prolonged post-induction hypotension.
Incidence of prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of maximum diameter of IVC in predicting prolonged post-induction hypotension.
The accuracy of maximum diameter of IVC in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of minimum diameter of IVC in predicting prolonged post-induction hypotension.
The accuracy of minimum diameter of IVC in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of IVC collapsibility index in predicting prolonged post-induction hypotension.
The accuracy of IVC collapsibility index in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of IJV area in supine position in predicting prolonged post-induction hypotension.
The accuracy of IJV area in supine position in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of IJV area in Trendelenburg position in predicting prolonged post-induction hypotension.
The accuracy of IJV area in Trendelenburg position in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
The accuracy of IJV change rate in predicting prolonged post-induction hypotension.
The accuracy of IJV change rate in predicting prolonged post-induction hypotension.
Measured: Intra-operative along the time of the study
Incidence of severe post-induction hypotension.
Incidence of severe post-induction hypotension (defined as MBP < 60% of the baseline preoperative reading) until 15 minutes after anesthetics administration or until skin incision whichever is earlier.
Measured: Intra-operative along the time of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jun 2020
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound Based IVC IJVStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Fathy Ahmed Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526625
- Sponsor's protocol ID
- MD-13-2020
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- 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 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound-Based Measures Of Inferior Vena Cava And Internal Jugular Vein For Prediction Of Hypotension During Induction Of General Anesthesia
- ClinicalTrials.gov ID
- NCT05526625
- Acronym / sponsor ID
- MD-13-2020
- Conditions
- Ultrasound Based IVC IJV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 2 Sep 2022 (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.
Hypotension after induction of general anesthesia is a frequent event in routine practice. Even a short period of hypotension may lead to tissue hypoperfusion and predispose to postoperative complications. Intra-operative hypotension is associated with renal injury, ischemic stroke, myocardial injury and postoperative mortality in patients having non-cardiac surgery under general anesthesia. Underlying hypovolemia is an important and modifiable risk factor for hypotension after anesthetics administration. Ultrasonographic studies of the inferior vena cava (IVC) and the internal jugular vein (IJV) for evaluation of intravascular volume status and prediction of hypotension during induction of general anesthesia have been established.
The present study was designed to compare, on ultrasound-based measures, between inferior vena cava and internal jugular vein for prediction of prolonged hypotension during induction of general anesthesia. The study was conducted at Kasr Al-Ainy hospital, Cairo University in Patients undergoing elective non-cardiac surgery under general anesthesia.
Detailed description
Upon arrival to the operating room, routine monitors in the form of pulse oximetry, electrocardiogarm and non-invasive blood pressure monitors were applied. Intravenous line was secured and routine premedications (ranitidine 50 mg and ondansetron 4 mg) were administered.
IVC evaluation was done for the patients in the supine position. The examination was performed after 5 minutes rest. A curved ultrasound transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea) was placed in the subcostal area to visualize the IVC in the paramedian long-axis view. The IVC was visualized using two-dimensional mode as it enters the right atrium; then, pulse wave doppler was used to differentiate the IVC from the aorta. Respiratory variations of the IVC diameter were evaluated using M-mode imaging at medium sweep speed 2 to 3 cm distal to the right atrium. The measures were obtained 3 times and their average was calculated. Maximum and minimum IVC diameters over a single respiratory cycle were used to calculate the collapsibility index as follows:
(dIVCmax- dIVCmin)/dIVCmax Collapsibility index was expressed as a percentage.
IJV measurements were obtained in the supine position using a linear ultrasound transducer (5 - 13 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The probe was placed horizontally at the middle level of the thyroid cartilage. After obtaining a clear transverse view of the right IJV, the IJV area was measured. The measures were repeated after changing the patient's position to the 10° Trendelenburg position. The maximum area of the IJV in the supine and Trendelenburg positions was recorded and the rate of change in IJV area was calculated as follows:
IJV change rate with posture = (IJV area in Trendelenburg position - IJV area in supine position)/(IJV area in Trendelenburg position) All ultrasonographic measurements were performed by a single trained anesthesiologist.
IJV measurements were obtained in the supine position using a linear ultrasound transducer (5 - 13 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The probe was placed horizontally at the middle level of the thyroid cartilage. After obtaining a clear transverse view of the right IJV, the IJV area was measured. The measures were repeated after changing the patient's position to the 10° Trendelenburg position. The maximum area of the IJV in the supine and Trendelenburg positions was recorded and the rate of change in IJV area was calculated as follows:
IJV change rate with posture = (IJV area in Trendelenburg position - IJV area in supine position)/(IJV area in Trendelenburg position) All ultrasonographic measurements were performed by a single trained anesthesiologist.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing elective non-cardiac surgery under general anesthesia in Kasr Al-Ainy hospital.
Key inclusion criteria (3 listed)
- Patients aged 18 - 50 years old
- Any scheduled non-cardiac surgery under general anesthesia
- ASA I, II
Key exclusion criteria (9 listed)
- Patients with major vascular disease
- Unstable angina
- Ejection fraction < 40 %
- Respiratory distress
- Increased intra-abdominal pressure.
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-based measurements of IVC & IJV.Ultrasound-based measurements of IVC \& IJV. | Other | – |
Primary outcome
Comparison of the accuracy of IVC and IJV variations in prediction of prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
Comparison of the accuracy (area under receiver operating characteristic curves) of IVC and IJV variations in prediction of prolonged post-induction hypotension (defined as MBP < 80% of the baseline reading for 2 minutes or more).
8 secondary outcomes
Incidence of prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of maximum diameter of IVC in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of minimum diameter of IVC in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of IVC collapsibility index in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of IJV area in supine position in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of IJV area in Trendelenburg position in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
The accuracy of IJV change rate in predicting prolonged post-induction hypotension.
Time frame: Intra-operative along the time of the study
Incidence of severe post-induction hypotension.
Time frame: Intra-operative along the time of the study
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 2 Sep 2022.
- Individual participant dataSharing planned: No
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 Ultrasound Based IVC IJV, 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 3 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 2 Sep 2022. 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 of IVC and IJV variations in prediction of prolonged post-induction hypotension. (time frame: Intra-operative along the time of the study). 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 2 Sep 2022.