Hemodynamic InstabilityNCT03337386
Subclavian Versus Inferior Vena Cava Collapsibility Indices.
A study testing inferior vena cava collapsibility, subclavian vein collapsibility and central venous pressure in people with Hemodynamic Instability, run by Mansoura University at 1 site in Egypt.
Trial summary
Traditional methods for intravascular volume status assessment include physical examination, raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion pressure (PAWP). Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- inferior vena cava collapsibility, subclavian vein collapsibility and central venous pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2017to 20 May 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. American society of anaesthesiologists physical status grade I and grade II .
- 2. Elective laparotomy. 3. Supine position
Who cannot join
- Patient refusal .
- Portal hypertension .
- Severe peripheral vascular diseases.
- Obstructive lung diseases .
- Right sided heart failure , arrhythmia and valvular heart heart diseases .
- Body mass index >35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Subclavian Vein Versus Inferior Vena Cava Collapsibility Indices for Preload Assessment.
Traditional methods for intravascular volume status assessment include physical examination, raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive and associated with significant complications. More recently, a number of less invasive techniques have been introduced, but they lack standardization and reliability. Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.
Read the detailed description
The aim of this study is that measurement of subclavian vein collapsibility index(SCV-CI) could be potential adjunct to IVC-CI where the IVC visualization is impaired or not possible .
-Finding a non-invasive reliable accurate method for evaluation of intravascular volume and response to volume resuscitation.
- Conditions
- Hemodynamic Instability
- Being tested
- inferior vena cava collapsibility, subclavian vein collapsibility, central venous pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior vena cava collapsibilityDiagnostic test
inferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI).
subclavian vein collapsibilityDiagnostic test
Right SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used.
central venous pressureDiagnostic test
ultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Vena Cava Collapsibility | Experimental | inferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI). Receives: Diagnostic Test: inferior vena cava collapsibility |
| Subclavian Vein Collapsibility | Experimental | Right SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used. Receives: Diagnostic Test: subclavian vein collapsibility |
| central venous pressure | Active comparator | ultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP. Receives: Diagnostic Test: central venous pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
inferior vena cava collapsibility index changes
ultrasound M mode maximum minus minimum over maximum then multiply by 100
Measured: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after10 ml/kg ringers preload, 4th 5 minutes before extubation.
Secondary outcomes (7)
subclavian vein collapsibility index changes
ultrasound M mode maximum minus minimum over the maximum then multiply by 100
Measured: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
central venous pressure changes
centimeter water
Measured: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
heart rate changes
beat per minute
Measured: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
mean blood pressure changes
millimeter mercury
Measured: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
fluid administration
milliliter
Measured: Intraoperative
blood loss
milliliter
Measured: intraoperative
urine output
milliliter
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start12 Nov 2017
- Primary completion10 Apr 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mazy Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337386
- Sponsor's protocol ID
- MS/17.05.137
- Status last verified
- Sep 2020
- First submitted
- 3 Nov 2017
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Subclavian Vein Versus Inferior Vena Cava Collapsibility Indices for Preload Assessment.
- ClinicalTrials.gov ID
- NCT03337386
- Acronym / sponsor ID
- MS/17.05.137
- Conditions
- Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Nov 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 9 Nov 2017 (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.
Traditional methods for intravascular volume status assessment include physical examination, raised leg test, central venous pressure (CVP) and pulmonary artery catheters occlusion pressure (PAWP). Central venous pressure and pulmonary artery occlusion pressure are invasive and associated with significant complications. More recently, a number of less invasive techniques have been introduced, but they lack standardization and reliability. Ultrasonically, inferior vena cava collapsibility can detect hypovolemia non-invasively.
Detailed description
The aim of this study is that measurement of subclavian vein collapsibility index(SCV-CI) could be potential adjunct to IVC-CI where the IVC visualization is impaired or not possible .
-Finding a non-invasive reliable accurate method for evaluation of intravascular volume and response to volume resuscitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inferior Vena Cava Collapsibility | Experimental | Diagnostic Test: inferior vena cava collapsibilityinferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI). |
| Subclavian Vein Collapsibility | Experimental | Diagnostic Test: subclavian vein collapsibilityRight SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used. |
| central venous pressure | Active comparator | Diagnostic Test: central venous pressureultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. American society of anaesthesiologists physical status grade I and grade II .
- 2. Elective laparotomy. 3. Supine position
Key exclusion criteria (6 listed)
- Patient refusal .
- Portal hypertension .
- Severe peripheral vascular diseases.
- Obstructive lung diseases .
- Right sided heart failure , arrhythmia and valvular heart heart diseases .
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 |
|---|---|---|
| inferior vena cava collapsibilityinferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI). | Diagnostic test | Inferior Vena Cava Collapsibility |
| subclavian vein collapsibilityRight SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used. | Diagnostic test | Subclavian Vein Collapsibility |
| central venous pressureultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP. | Diagnostic test | central venous pressure |
Primary outcome
inferior vena cava collapsibility index changes
Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after10 ml/kg ringers preload, 4th 5 minutes before extubation.
ultrasound M mode maximum minus minimum over maximum then multiply by 100
7 secondary outcomes
subclavian vein collapsibility index changes
Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
central venous pressure changes
Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
heart rate changes
Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
mean blood pressure changes
Time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after 10 ml/kg ringers preload, 4th 5 minutes before extubation.
fluid administration
Time frame: Intraoperative
blood loss
Time frame: intraoperative
urine output
Time frame: intraoperative
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 18 Sep 2020.
Related trials for Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
RecruitingObservational study
Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
Intraoperative Hypotension, Perioperative Care
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
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?
A study testing inferior vena cava collapsibility, subclavian vein collapsibility and central venous pressure in people with Hemodynamic Instability, run by Mansoura 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 6 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 18 Sep 2020. 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?
inferior vena cava collapsibility index changes (time frame: intraoperative changes:1st basal before induction of anesthesia, 2nd before start of surgery, 3rd after10 ml/kg ringers preload, 4th 5 minutes before extubation.). 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 18 Sep 2020.