IVC Collapsibility Index as Predictor for HypotensionNCT05368363
Inferior Vena Cava Collapsibility Index and Caval Aorta Index for Prediction of Hypotension General Anaesthesia
An observational study of IVC Collapsibility Index as Predictor for Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
1. To estimate sensitivity and specificity of preoperative IVCCI, max aortic diameter and IVC:Ao index as predictors of hypotension after induction of general anesthesia. 2. To compare accuracy of preoperative values of IVC: Ao index to preoperative IVCCI in prediction of hypotension after induction of general… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IVC Collapsibility Index as Predictor for Hypotension
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2022to 27 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients aged 18 - 60 years old , Patients undergoing elective surgery under general anesthesia, ASA I, II
Who may be able to join
- Patients aged 18 - 60 years old
- Patients undergoing elective surgery under general anesthesia.
- ASA I, II
Who cannot join
- Patients with BMI more than 35.
- Pregnant patients
- Emergency cases
- Patients with a baseline arterial SBP less than 90 mmHg or mean arterial pressure (MAP) less than 70 mmHg.
- Patients with major severe vascular disease, Unstable angina, Ejection fraction< 40 %, Respiratory distress, Implanted pacemaker or Patients on angiotensin converting enzyme inhibitors or angiotensin receptor blockers
- Patients with increased intra-abdominal pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Preoperative Evaluation of Inferior Vena Cava Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anaesthesia: "A Prospective Observational Study"
- To estimate sensitivity and specificity of preoperative IVCCI, max aortic diameter and IVC:Ao index as predictors of hypotension after induction of general anesthesia.
- To compare accuracy of preoperative values of IVC: Ao index to preoperative IVCCI in prediction of hypotension after induction of general anesthesia.
Read the detailed description
After obtaining approval from the hospital ethics committee, informed consent will be obtained from 102 patients who will undergo elective surgery requiring general anaesthesia in supine position. Patients will be evaluated by history taking and proper examination. Pre-operative investigations will be checked. On the day of surgery, pre-operative fasting for 8 hours will be confirmed.
Upon arrival to the operating room, routine monitors in the form of pulse oximetry, electrocardiogarm and non-invasive blood pressure monitors will be applied. Intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansetron 4 mg) will be administered.
- IVC Ultrasonography (IVCCI and IVC:Ao index) : While the patient is lying supine, the IVC and aorta will be examined before induction of general anaesthesia using a curved ultrasound transducer set to abdominal mode with a B-mode scan (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The transducer is placed in the subxiphoid region in a longitudinal position. IVC measurements are made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC is identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCDmax) and minimum (IVCDmin) 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: (7) IVCCI = [ (IVCDmax - IVCDmin) / IVCDmax ] X 100. To the left of the IVC, the abdominal aorta is visualized 10 mm above the coeliac trunk. The maximum internal AP diameter of the abdominal aorta is measured during systole. The IVC:Ao index is derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole.
- Induction of anesthesia:
Standard noninvasive monitoring including ECG, noninvasive blood pressure (BP) measurements every minute and oxygen saturation will be applied. Heart rate (HR), SBP and MBP will be recorded immediately before general anaesthesia and will be defined as baseline readings.
General anaesthesia induction will be started using propofol intravenous anaesthetic (2 mg/kg) and Fentanyl (1 microgram/kg) and Atracrurium non-depolarizing muscle relaxant (0.5 mg/kg).Smooth endotracheal intubation with appropriate sized-cuffed endotracheal tube will be done after 3 mins of manual bag mask ventilation. Confirmation of endotracheal intubation will be done by 3 successive capnography waves and by bilateral lung auscultation. Meanwhile, the noninvasive BP will be recorded immediately after induction, then 5 and 10 minutes post induction, with continuous monitoring of other vital parameters (HR and oxygen saturation) during the postinduction period.
Any episode of hypotension (defined as mean arterial pressure < 80% of the baseline reading or or MAP less than 60 mmHg) will be managed by ephedrine 5 mg every 2 min to increase SBP to 80% of the baseline or MAP more than 70 mmHg. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered. Any episodes of bradycardia (defined as heart rate less than 50 bpm) will be managed by atropine (0.01 mg/kg).
Patients will then be divided into two groups depending on whether they'll develop post general anesthesia induction hypotension or won't. Any complications, such as hypoxia or allergic reaction will be noted and managed accordingly.
The attending anesthesiologist who will perform the induction of general anaesthesia and monitor the patient during the study period will be blinded to the ultrasound measurements of IVCCI and IVC :Ao index recorded pre-operatively.
Measurement tools
- Mean arterial blood pressure will be measured in supine position in one of the upper limbs in the operating room at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: 1-minute post-induction reading, 2-minutes post-induction reading, pre-intubation reading \& post-intubation readings until skin incision. Taking in consideration that the maximum time for recording the readings of the blood pressure is 15 minutes because if hypotension occurred after this time it is unlikely to be due to the effect of induction of anesthesia.
- Heart rate will be recorded at 1-minute intervals starting from the baseline pre-operative reading until skin incision as follows: 1-minute post-induction reading, 2-minutes post-induction reading, pre-intubation reading \& post-intubation readings until skin incision.
- Demographic data: (age - gender - comorbidities - current medications).
- The incidence of post-induction hypotension.
- The incidence of bradycardia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
Measured: 5 minutes
Secondary outcomes (2)
Correlation between each of maximum aortic diameter with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Correlation between each of maximum aortic diameter with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Measured: 5 minutes
Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start30 May 2022
- Primary completion25 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IVC Collapsibility Index as Predictor for HypotensionStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Omar Ahmed, Cairo University
- Investigators
- Heba Omar, Study director, associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368363
- Sponsor's protocol ID
- MD-266-2020
- Status last verified
- Jul 2022
- First submitted
- 6 May 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
PubMed 26771910Salama ER, Elkashlan M. Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):297-302. doi: 10.1097/EJA.0000000000000956.
PubMed 30664523
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Preoperative Evaluation of Inferior Vena Cava Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anaesthesia: "A Prospective Observational Study"
- ClinicalTrials.gov ID
- NCT05368363
- Acronym / sponsor ID
- MD-266-2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 10 May 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.
- To estimate sensitivity and specificity of preoperative IVCCI, max aortic diameter and IVC:Ao index as predictors of hypotension after induction of general anesthesia.
- To compare accuracy of preoperative values of IVC: Ao index to preoperative IVCCI in prediction of hypotension after induction of general anesthesia.
Detailed description
After obtaining approval from the hospital ethics committee, informed consent will be obtained from 102 patients who will undergo elective surgery requiring general anaesthesia in supine position. Patients will be evaluated by history taking and proper examination. Pre-operative investigations will be checked. On the day of surgery, pre-operative fasting for 8 hours will be confirmed.
Upon arrival to the operating room, routine monitors in the form of pulse oximetry, electrocardiogarm and non-invasive blood pressure monitors will be applied. Intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansetron 4 mg) will be administered.
- IVC Ultrasonography (IVCCI and IVC:Ao index) : While the patient is lying supine, the IVC and aorta will be examined before induction of general anaesthesia using a curved ultrasound transducer set to abdominal mode with a B-mode scan (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). The transducer is placed in the subxiphoid region in a longitudinal position. IVC measurements are made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC is identified by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCDmax) and minimum (IVCDmin) 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: (7) IVCCI = [ (IVCDmax - IVCDmin) / IVCDmax ] X 100. To the left of the IVC, the abdominal aorta is visualized 10 mm above the coeliac trunk. The maximum internal AP diameter of the abdominal aorta is measured during systole. The IVC:Ao index is derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole.
- Induction of anesthesia:
Standard noninvasive monitoring including ECG, noninvasive blood pressure (BP) measurements every minute and oxygen saturation will be applied. Heart rate (HR), SBP and MBP will be recorded immediately before general anaesthesia and will be defined as baseline readings.
General anaesthesia induction will be started using propofol intravenous anaesthetic (2 mg/kg) and Fentanyl (1 microgram/kg) and Atracrurium non-depolarizing muscle relaxant (0.5 mg/kg).Smooth endotracheal intubation with appropriate sized-cuffed endotracheal tube will be done after 3 mins of manual bag mask ventilation. Confirmation of endotracheal intubation will be done by 3 successive capnography waves and by bilateral lung auscultation. Meanwhile, the noninvasive BP will be recorded immediately after induction, then 5 and 10 minutes post induction, with continuous monitoring of other vital parameters (HR and oxygen saturation) during the postinduction period.
Any episode of hypotension (defined as mean arterial pressure < 80% of the baseline reading or or MAP less than 60 mmHg) will be managed by ephedrine 5 mg every 2 min to increase SBP to 80% of the baseline or MAP more than 70 mmHg. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered. Any episodes of bradycardia (defined as heart rate less than 50 bpm) will be managed by atropine (0.01 mg/kg).
Patients will then be divided into two groups depending on whether they'll develop post general anesthesia induction hypotension or won't. Any complications, such as hypoxia or allergic reaction will be noted and managed accordingly.
The attending anesthesiologist who will perform the induction of general anaesthesia and monitor the patient during the study period will be blinded to the ultrasound measurements of IVCCI and IVC :Ao index recorded pre-operatively.
Measurement tools
- Mean arterial blood pressure will be measured in supine position in one of the upper limbs in the operating room at 1-minute intervals starting from the baseline preoperative reading until skin incision as follows: 1-minute post-induction reading, 2-minutes post-induction reading, pre-intubation reading \& post-intubation readings until skin incision. Taking in consideration that the maximum time for recording the readings of the blood pressure is 15 minutes because if hypotension occurred after this time it is unlikely to be due to the effect of induction of anesthesia.
- Heart rate will be recorded at 1-minute intervals starting from the baseline pre-operative reading until skin incision as follows: 1-minute post-induction reading, 2-minutes post-induction reading, pre-intubation reading \& post-intubation readings until skin incision.
- Demographic data: (age - gender - comorbidities - current medications).
- The incidence of post-induction hypotension.
- The incidence of bradycardia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients aged 18 - 60 years old , Patients undergoing elective surgery under general anesthesia, ASA I, II
Key inclusion criteria (3 listed)
- Patients aged 18 - 60 years old
- Patients undergoing elective surgery under general anesthesia.
- ASA I, II
Key exclusion criteria (6 listed)
- Patients with BMI more than 35.
- Pregnant patients
- Emergency cases
- Patients with a baseline arterial SBP less than 90 mmHg or mean arterial pressure (MAP) less than 70 mmHg.
- Patients with major severe vascular disease, Unstable angina, Ejection fraction< 40 %, Respiratory distress, Implanted pacemaker or Patients on angiotensin converting enzyme inhibitors or angiotensin receptor blockers
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
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
Time frame: 5 minutes
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension
2 secondary outcomes
Correlation between each of maximum aortic diameter with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Time frame: 5 minutes
Correlation between each of IVC collapsibility index with the percentage of themaximum decrease in mean arterial pressure after induction of anesthesia
Time frame: 5 minutes
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 29 Jul 2022.
- Background: PubMed 26771910Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
- Background: PubMed 30664523Salama ER, Elkashlan M. Pre-operative ultrasonographic evaluation of inferior vena cava collapsibility index and caval aorta index as new predictors for hypotension after induction of spinal anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2019 Apr;36(4):297-302. doi: 10.1097/EJA.0000000000000956.
- 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.
Heba Omar study director
associate professor of anesthesia and surgical ICU, faculty of medicine, 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 IVC Collapsibility Index as Predictor for Hypotension, 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 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 29 Jul 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?
Area under receiver operating characteristic curves (AUROC) of the preoperative IVCCI inprediction of post-induction hypotension (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05368363, which also lists 2 linked publications.
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 29 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.