Total Fluid Volume DecreasedSVC IVC CINCT05548920
Preoperative Ultrasound Guided Evaluation of SVC-CI and IVC -CI as Predictors of Hypotension After Induction of Anaesthesia in Major Onco-surgery
An observational study of Total Fluid Volume Decreased, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Total Fluid Volume Decreased
- What is being tested?
- Ultrasound guided Superior Vena Cava Collapsibility Index and Inferior Vena Cava Collapsibility Index
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jun 2021to 10 Jan 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing major Onco-surgeries.
Who may be able to join
- Patients belonging to ASA Grade I,II,III
- For major Oncosurgery under general anaesthesia
Who cannot join
- Patient refusal
- BMI>30
- Emergency surgery
- Preoperative Hypotension MAP < 70 mmHg
- LVEF<40%
- Difficult Airway
- Nasal Intubation
- Inability to obtain good ultrasound images of SCV and IVC .
Trial locations and contacts
1 site in 1 country.
India1 site
Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, National Capital Territory of Delhi, 110085
About this study
Official title: Preoperative Ultrasound Guided Evaluation of Subclavian Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index as Predictors of Hypotension After Induction of General Anesthesia in Major Onco-surgery
Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia.
Read the detailed description
Investigators plan prospective study , written informed will be taken from all included patients. In the OR 5 lead ECG, NIBP,SPO2 monitors will be attached , patients will be explained about Ultrasound imaging . Preinduction using SONOSITE EDGE II ultrasonography machine and placing high frequency linear array probe (6-13 Hz) beneath the middle of the clavicle aligned in deltopectoral groove to obtain short axis view of Subclavian/Infraclavicular axillary vein in B-Mode (2-D imaging). Doppler pulse waveform and minimum and maximum diameter measurements of SVC will be obtained in M-mode , both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will be calculated using the following equation SCV AV CI = (dSCV max- dSCV min)/ dSCV max ×100.
A phased array or cardiac ultrasound probe (1-5Hz) will be placed in the subxiphoid window to view IVC at the junction of IVC with right atrium .Then the transducer will be adjusted to obtain the long axis view of IVC. Doppler pulse waveform will be obtained to ensure imaging of IVC and then in the M mode the minimum and maximum diameter measurements of IVC will be obtained both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will calculated using the following equation:IVC CI = (dIVCmax- dIVCmin )/ dIVCmax ×100 . In all the patients both SVC and IVC -CI will be calculated.
All patients will receive standard General Anesthesia with IV Fentanyl 1-2 mcg/kg , Sleeping dose propofol , Atracurium 0.5mg/kg and orally placed Endotracheal tube.The heart rate (HR) and mean arterial pressure (MAP) will be recorded in two phases .Intraoperative hypotension (IOH) been defined as MAP<60mmHg or >30%decrease in MAP from baseline.
- Post induction phase: Readings will be taken at 1 min intervals from the start of induction till intubation (upto 5 minutes) and
- Post intubation phase: Readings will be taken at 2 min intervals upto 10 min and at 5 min intervals up to 30 mins or till incision . Each hypotensive episode encountered will be treated with leg lifting first (lifting both lower extremities for 2 minutes by technical staff) , if hypotension persists then IV Ephedrine 6 mg boluses will be given . All patients will receive preloading 200ml crystalloids prior to induction of anesthesia .
- Conditions
- Total Fluid Volume Decreased
- Being tested
- Ultrasound guided Superior Vena Cava Collapsibility Index, Inferior Vena Cava Collapsibility Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Superior Vena Cava Collapsibility IndexOther
Preoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured
Inferior Vena Cava Collapsibility IndexOther
Preoperative Inferior Vena Cava Collapsibility Index will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI) | Preoperative ultrasound guided Superior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration. Receives: Other: Ultrasound guided Superior Vena Cava Collapsibility Index | |
| Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI) | Preoperative Ultrasound guided Inferior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration. Receives: Other: Inferior Vena Cava Collapsibility Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Subclavian Vein Collapsibility Index in percentage with Inferior Vena Cava Collapsibility Index in percentage as predictor of hypotension after induction of General anaesthesia
Preoperative Ultrasound guided Subclavian / Infraclavicular Axillary Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index was measured with spontaneous breathing and on deep inspiration.
Measured: 30 minutes prior to induction of anaesthesia
Secondary outcomes (1)
To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .
Preoperative US Guided SVC-CI in percentage and IVC -CI in percentage values will be obtained and statistical analysis will be done
Measured: 30 minutes prior to induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start26 Jun 2021
- Primary completion30 Dec 2022
- Study completion10 Jan 2023
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 Total Fluid Volume DecreasedStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Anita C Kulkarni, MD, Principal investigator, Senior Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548920
- Sponsor's protocol ID
- SCV IVC Collapsibility
- Acronym
- SVC IVC CI
- Status last verified
- Jan 2023
- First submitted
- 14 Sep 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi MH, Chae JS, Lee HJ, Woo JH. Pre-anaesthesia ultrasonography of the subclavian/infraclavicular axillary vein for predicting hypotension after inducing general anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2020 Jun;37(6):474-481. doi: 10.1097/EJA.0000000000001192.
PubMed 32205573Kaptein YE, Kaptein EM. Comparison of subclavian vein to inferior vena cava collapsibility by ultrasound in acute heart failure: A pilot study. Clin Cardiol. 2022 Jan;45(1):51-59. doi: 10.1002/clc.23758. Epub 2021 Dec 21.
PubMed 34931333
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound Guided Evaluation of Subclavian Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index as Predictors of Hypotension After Induction of General Anesthesia in Major Onco-surgery
- ClinicalTrials.gov ID
- NCT05548920
- Acronym / sponsor ID
- SVC IVC CI / SCV IVC Collapsibility
- Conditions
- Total Fluid Volume Decreased
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 22 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.
Patients undergoing major Oncosurgeries are fluid deficit due to preoperative fasting , inadequate intake due to disease hence prone to development of hypotension after induction of general anaesthesia owing to vasodilatory effects of anesthetic induction agents. Investigators plan study to measure ultrasound guided Superior Vena Cava and Inferior Vena Cava collapsibility Index as predictors of hypotension after induction of General anaesthesia.
Detailed description
Investigators plan prospective study , written informed will be taken from all included patients. In the OR 5 lead ECG, NIBP,SPO2 monitors will be attached , patients will be explained about Ultrasound imaging . Preinduction using SONOSITE EDGE II ultrasonography machine and placing high frequency linear array probe (6-13 Hz) beneath the middle of the clavicle aligned in deltopectoral groove to obtain short axis view of Subclavian/Infraclavicular axillary vein in B-Mode (2-D imaging). Doppler pulse waveform and minimum and maximum diameter measurements of SVC will be obtained in M-mode , both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will be calculated using the following equation SCV AV CI = (dSCV max- dSCV min)/ dSCV max ×100.
A phased array or cardiac ultrasound probe (1-5Hz) will be placed in the subxiphoid window to view IVC at the junction of IVC with right atrium .Then the transducer will be adjusted to obtain the long axis view of IVC. Doppler pulse waveform will be obtained to ensure imaging of IVC and then in the M mode the minimum and maximum diameter measurements of IVC will be obtained both during spontaneous breathing and after deep inspiration, using digital calipers after freezing the image. The collapsibility index CI will calculated using the following equation:IVC CI = (dIVCmax- dIVCmin )/ dIVCmax ×100 . In all the patients both SVC and IVC -CI will be calculated.
All patients will receive standard General Anesthesia with IV Fentanyl 1-2 mcg/kg , Sleeping dose propofol , Atracurium 0.5mg/kg and orally placed Endotracheal tube.The heart rate (HR) and mean arterial pressure (MAP) will be recorded in two phases .Intraoperative hypotension (IOH) been defined as MAP<60mmHg or >30%decrease in MAP from baseline.
- Post induction phase: Readings will be taken at 1 min intervals from the start of induction till intubation (upto 5 minutes) and
- Post intubation phase: Readings will be taken at 2 min intervals upto 10 min and at 5 min intervals up to 30 mins or till incision . Each hypotensive episode encountered will be treated with leg lifting first (lifting both lower extremities for 2 minutes by technical staff) , if hypotension persists then IV Ephedrine 6 mg boluses will be given . All patients will receive preloading 200ml crystalloids prior to induction of anesthesia .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI) | – | Other: Ultrasound guided Superior Vena Cava Collapsibility IndexPreoperative ultrasound guided Superior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration. |
| Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI) | – | Other: Inferior Vena Cava Collapsibility IndexPreoperative Ultrasound guided Inferior Vena Cava collapsibility Index will be measured with patient breathing spontaneously and on deep inspiration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing major Onco-surgeries.
Key inclusion criteria (2 listed)
- Patients belonging to ASA Grade I,II,III
- For major Oncosurgery under general anaesthesia
Key exclusion criteria (8 listed)
- Patient refusal
- BMI>30
- Emergency surgery
- Preoperative Hypotension MAP < 70 mmHg
- LVEF<40%
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 guided Superior Vena Cava Collapsibility IndexPreoperative Ultrasound guided Superior Vena Cava Collapsibility Index will be measured | Other | Ultrasound guided Superior Vena Cava Collapsibility Index (SVC - CI) |
| Inferior Vena Cava Collapsibility IndexPreoperative Inferior Vena Cava Collapsibility Index will be measured. | Other | Ultrasound Guided Inferior Vena Cava Collapsibility Index (IVC -CI) |
Primary outcome
To compare Subclavian Vein Collapsibility Index in percentage with Inferior Vena Cava Collapsibility Index in percentage as predictor of hypotension after induction of General anaesthesia
Time frame: 30 minutes prior to induction of anaesthesia
Preoperative Ultrasound guided Subclavian / Infraclavicular Axillary Vein Collapsibility Index and Inferior Vena Cava Collapsibility Index was measured with spontaneous breathing and on deep inspiration.
1 secondary outcome
To evaluate the sensitivity of SVC -CI and IVC -CI as a predictor of hypotension after induction of General anesthesia .
Time frame: 30 minutes prior to induction of anaesthesia
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 Jan 2023.
- Results publication: PubMed 32205573Choi MH, Chae JS, Lee HJ, Woo JH. Pre-anaesthesia ultrasonography of the subclavian/infraclavicular axillary vein for predicting hypotension after inducing general anaesthesia: A prospective observational study. Eur J Anaesthesiol. 2020 Jun;37(6):474-481. doi: 10.1097/EJA.0000000000001192.
- Results publication: PubMed 34931333Kaptein YE, Kaptein EM. Comparison of subclavian vein to inferior vena cava collapsibility by ultrasound in acute heart failure: A pilot study. Clin Cardiol. 2022 Jan;45(1):51-59. doi: 10.1002/clc.23758. Epub 2021 Dec 21.
- 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.
Anita C Kulkarni, MD principal investigator
Senior Consultant
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 Total Fluid Volume Decreased, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 8 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 Jan 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 India. 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?
To compare Subclavian Vein Collapsibility Index in percentage with Inferior Vena Cava Collapsibility Index in percentage as predictor of hypotension after induction of General anaesthesia (time frame: 30 minutes prior to induction of anaesthesia). 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 NCT05548920, 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 18 Jan 2023.