Cesarean SectionNCT04519996
Pre-operative Ultrasonographic Evaluation of the Internal Jugular Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index to Predict Post Spinal Hypotension in Pregnant Women Undergoing Caesarean Section
A study testing US Internal Jugular Vein Collapsibility Index measurment and US Inferior Vena Cava Collapsibility Index measurment in people with Cesarean Section, run by Tanta University.
Trial summary
Postspinal hypotension (PSH) is common in obstetric anesthesia practice, with an incidence of up to 71 %. PSH can occur precipitously and, if severe, can result in both maternal and fetal/neonatal adverse events. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- US Internal Jugular Vein Collapsibility Index measurment and US Inferior Vena Cava Collapsibility Index measurment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2020to 1 Dec 2020
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1.55 female patients 2. aged 20-40 years 3.ASA Physical Status Class I and II 4. scheduled for elective lower segment cesarean section
Who cannot join
- Patients who will refuse
- Emergency LSCS
- Patients with expected massive intraoperative blood loss e.g. placenta Previa and placenta accreta
- Cardiovascular, respiratory, renal diseases
- Patients who will receive preloading of intravenous fluid
About this study
Postspinal hypotension (PSH) is common in obstetric anesthesia practice, with an incidence of up to 71 %. PSH can occur precipitously and, if severe, can result in both maternal and fetal/neonatal adverse events. Pregnant women with predelivery hypovolemia are at risk of cardiovascular collapse and the sympathetic blockade may severely decrease venous return. Hence, prevention of PSH is an essential element in obstetric anesthesia and fasting for aspiration prophylaxis may further add up to the hypovolemia for the patients not on maintenance fluids.
Hemodynamic monitoring in obstetric patients has evolved during the last decade, with the development of minimally invasive and noninvasive continuous cardiac output (CO) monitors. Ultrasound (USG) is a method for noninvasive hemodynamic optimization in the ICU and ED, and it may be more helpful than other noninvasive methods. Transabdominal USG measurements of inferior vena cava (IVC) are noninvasive and thus are not associated with complications. USG of the IVC diameter is a useful and easy method for assessing a patient's volume status by calculating the IVC collapsibility index (IVCCI).
Read more
Recently, the usefulness of point-of-care ultrasonographic examination, performed by anesthesiologists in real time, for perioperative management has been reported . Ultrasonographic studies have established the utility of measuring the inferior vena cava (IVC) or internal jugular Vein (IJV) for evaluating intravascular volume status .
In particular, IVC diameter and collapsibility, obtained from ultrasonographic measurement, have been demonstrated to be predictors of hypotension after anesthetic administration.
Read the detailed description
Pregnant women planned for elective surgery will be advised for nil per oral after midnight and. After detailed preanesthetic checkup, on arrival in operating room, standard monitoring devices will be attached (pulse oximeter, noninvasive blood pressure and 3-lead electrocardiography).
Machine
A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm). A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used.
Measurements
IJV measurement
All the measurements will be done on Right IJV with the patients initially lying supine at 0° and later head end elevated at 30°. With the patients in supine position, the USG transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position
IVC measurements
The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100.
The patients will be positioned in sitting position to give the spinal anesthesia at L3-L4/L2-L3 intervertebral level in the midline approach. After local infiltration of skin and subcutaneous tissue with 2% lignocaine, 25 G B-braun spinal needle will be used to administer subarachnoid block (SAB) with 2.5 ml of hyperbaric bupivacaine (5%) and 20 µg of fentanyl after confirmation of free flow of cerebrospinal fluid (CSF) at the hub of the needle. Patients will be coloaded with 10-12 ml/kg (over the period of 15 min) of Ringer's Lactate (RL) solution at the time of SAB. Thereafter, patients will be placed in supine position with wedge under the right hip. HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and SpO2 will be recorded throughout the procedure every 3 min till 15 min of SAB. Level of sensory block will be assessed by response to cold touch and surgery will be allowed after sensory blocks reaches to T6 level. Hypotension (reduction in MAP more than 20% and/or MAP <65 mmHg) will be treated with 6 mg of injection of ephedrine and a bolus of 250 ml of Ringer's Lactate (RL) solution over 10 minutes. Number of boluses of ephedrine and fluids will be recorded. Bradycardia (Heart Rate < 50 beats/ min) will be treated with 0.6 mg of injection atropine.
Data collection
The attending anaesthesiologist who will perform subarachnoid block (SAB) and will monitor the patient during the study period will be blinded to the ultrasound measurements of both inferior vena cava collapsibility index (IVCCI) and internal jugular vein collapsibility index (IJVCI) which will be recorded by either of the two investigators pre-operatively.
Measurements:
- Demographic data as age, weight, height and ASA status.
- Hemodynamics including heart rate, mean arterial blood pressure every 3 min till 15 min of SAB.
- Number of boluses of ephedrine and fluids will be recorded
- Inferior vena cava collapsibility index (IVCCI) and internal jugular vein collapsibility index (IJVCI).
- Conditions
- Cesarean Section
- Being tested
- US Internal Jugular Vein Collapsibility Index measurment, US Inferior Vena Cava Collapsibility Index measurment
- Keywords
- cesarean section, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US Internal Jugular Vein Collapsibility Index measurmentProcedure or surgery
Machine
A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm).
The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position.
US Inferior Vena Cava Collapsibility Index measurmentProcedure or surgery
Machine
A sonosite M-Turbo ultrasound machine will be used for all the examinations. A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used.
The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100.
| Study group | Role | What they receive |
|---|---|---|
| US Internal Jugular Vein Collapsibility Index | Experimental | The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Receives: Procedure: US Internal Jugular Vein Collapsibility Index measurment |
| US Inferior Vena Cava Collapsibility Index | Experimental | The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. Receives: Procedure: US Inferior Vena Cava Collapsibility Index measurment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-operative inferior vena cava collapsibility index (IVCCI)
for predicting post-spinal anaesthesia hypotension (PSAH). The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100
Measured: pre-operative
pre-operative internal jugular vein collapsibility index (IJVCI)
for predicting post-spinal anaesthesia hypotension (PSAH), The maximum, minimum antero-pestorior diameters, and cross-sectional area will be estimated and, from this, corresponding collapsibility index will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%.
Measured: pre-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start30 Oct 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Arafa Elbadry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519996
- Sponsor's protocol ID
- IJVCI versus IVCCI
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Ultrasonographic Evaluation of the Internal Jugular Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index to Predict Post Spinal Hypotension in Pregnant Women Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT04519996
- Acronym / sponsor ID
- IJVCI versus IVCCI
- Conditions
- Cesarean Section
- Keywords
- cesarean section, hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Aug 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.
Postspinal hypotension (PSH) is common in obstetric anesthesia practice, with an incidence of up to 71 %. PSH can occur precipitously and, if severe, can result in both maternal and fetal/neonatal adverse events. Pregnant women with predelivery hypovolemia are at risk of cardiovascular collapse and the sympathetic blockade may severely decrease venous return. Hence, prevention of PSH is an essential element in obstetric anesthesia and fasting for aspiration prophylaxis may further add up to the hypovolemia for the patients not on maintenance fluids.
Hemodynamic monitoring in obstetric patients has evolved during the last decade, with the development of minimally invasive and noninvasive continuous cardiac output (CO) monitors. Ultrasound (USG) is a method for noninvasive hemodynamic optimization in the ICU and ED, and it may be more helpful than other noninvasive methods. Transabdominal USG measurements of inferior vena cava (IVC) are noninvasive and thus are not associated with complications. USG of the IVC diameter is a useful and easy method for assessing a patient's volume status by calculating the IVC collapsibility index (IVCCI).
Recently, the usefulness of point-of-care ultrasonographic examination, performed by anesthesiologists in real time, for perioperative management has been reported . Ultrasonographic studies have established the utility of measuring the inferior vena cava (IVC) or internal jugular Vein (IJV) for evaluating intravascular volume status .
In particular, IVC diameter and collapsibility, obtained from ultrasonographic measurement, have been demonstrated to be predictors of hypotension after anesthetic administration.
Detailed description
Pregnant women planned for elective surgery will be advised for nil per oral after midnight and. After detailed preanesthetic checkup, on arrival in operating room, standard monitoring devices will be attached (pulse oximeter, noninvasive blood pressure and 3-lead electrocardiography).
Machine
A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm). A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used.
Measurements
IJV measurement
All the measurements will be done on Right IJV with the patients initially lying supine at 0° and later head end elevated at 30°. With the patients in supine position, the USG transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position
IVC measurements
The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100.
The patients will be positioned in sitting position to give the spinal anesthesia at L3-L4/L2-L3 intervertebral level in the midline approach. After local infiltration of skin and subcutaneous tissue with 2% lignocaine, 25 G B-braun spinal needle will be used to administer subarachnoid block (SAB) with 2.5 ml of hyperbaric bupivacaine (5%) and 20 µg of fentanyl after confirmation of free flow of cerebrospinal fluid (CSF) at the hub of the needle. Patients will be coloaded with 10-12 ml/kg (over the period of 15 min) of Ringer's Lactate (RL) solution at the time of SAB. Thereafter, patients will be placed in supine position with wedge under the right hip. HR, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and SpO2 will be recorded throughout the procedure every 3 min till 15 min of SAB. Level of sensory block will be assessed by response to cold touch and surgery will be allowed after sensory blocks reaches to T6 level. Hypotension (reduction in MAP more than 20% and/or MAP <65 mmHg) will be treated with 6 mg of injection of ephedrine and a bolus of 250 ml of Ringer's Lactate (RL) solution over 10 minutes. Number of boluses of ephedrine and fluids will be recorded. Bradycardia (Heart Rate < 50 beats/ min) will be treated with 0.6 mg of injection atropine.
Data collection
The attending anaesthesiologist who will perform subarachnoid block (SAB) and will monitor the patient during the study period will be blinded to the ultrasound measurements of both inferior vena cava collapsibility index (IVCCI) and internal jugular vein collapsibility index (IJVCI) which will be recorded by either of the two investigators pre-operatively.
Measurements:
- Demographic data as age, weight, height and ASA status.
- Hemodynamics including heart rate, mean arterial blood pressure every 3 min till 15 min of SAB.
- Number of boluses of ephedrine and fluids will be recorded
- Inferior vena cava collapsibility index (IVCCI) and internal jugular vein collapsibility index (IJVCI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US Internal Jugular Vein Collapsibility Index | Experimental | Procedure: US Internal Jugular Vein Collapsibility Index measurmentThe US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. |
| US Inferior Vena Cava Collapsibility Index | Experimental | Procedure: US Inferior Vena Cava Collapsibility Index measurmentThe transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.55 female patients 2. aged 20-40 years 3.ASA Physical Status Class I and II 4. scheduled for elective lower segment cesarean section
Key exclusion criteria (5 listed)
- Patients who will refuse
- Emergency LSCS
- Patients with expected massive intraoperative blood loss e.g. placenta Previa and placenta accreta
- Cardiovascular, respiratory, renal diseases
- Patients who will receive preloading of intravenous fluid
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 |
|---|---|---|
| US Internal Jugular Vein Collapsibility Index measurmentMachine A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm). The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position. | Procedure or surgery | US Internal Jugular Vein Collapsibility Index |
| US Inferior Vena Cava Collapsibility Index measurmentMachine A sonosite M-Turbo ultrasound machine will be used for all the examinations. A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used. The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100. | Procedure or surgery | US Inferior Vena Cava Collapsibility Index |
Primary outcome
pre-operative inferior vena cava collapsibility index (IVCCI)
Time frame: pre-operative
for predicting post-spinal anaesthesia hypotension (PSAH). The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100
pre-operative internal jugular vein collapsibility index (IJVCI)
Time frame: pre-operative
for predicting post-spinal anaesthesia hypotension (PSAH), The maximum, minimum antero-pestorior diameters, and cross-sectional area will be estimated and, from this, corresponding collapsibility index will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing US Internal Jugular Vein Collapsibility Index measurment and US Inferior Vena Cava Collapsibility Index measurment in people with Cesarean Section, run by Tanta University.
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 5 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
pre-operative inferior vena cava collapsibility index (IVCCI) (time frame: pre-operative). The study lists 2 primary outcomes in all. 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 27 Oct 2020.