HypotensionNCT02944266
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
An observational study of Hypotension, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This is an observational study to evaluate the role of a Bed side Focus assessed Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of developing hypotension secondary to general anesthesia induction using the FATE parameters like velocity time integral ( VTI ), Inferior venacava… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension
- What is being tested?
- Pre operative Focus assessed Transthoracic echocardiographic assessment.
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2016to Dec 2016
- 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
- Healthy volunteers accepted
- Adult
Study population: Any ASA - I/II patient posted for a routine general anaesthesia procedure who is between the age groups 18-60 years, with a BMI between 18-40 , without preexisting haemodynamic instability , sepsis or a documented ventricular dysfunction.
Who may be able to join
- Any ASA - I/II patient posted for a routine general anaesthesia procedure and who do not fit with the exclusion criteria.
Who cannot join
- a) Extremes of age <18 years and >60 years
- BMI<18 and >40
- Patients with pre-existing hemodynamic instability, ventricular dysfunction and
- Sepsis.
- Patients on beta blocking agents.
- Preinduction mean arterial pressure of <70 mm hg.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
J S Rahul
Chandigarh, Chandigarh, 160012
Dr vikas saini, MD, 7087008119, drvsaini@gmail.com
About this study
This is an observational study to evaluate the role of a Bed side Focus assessed Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of developing hypotension secondary to general anesthesia induction using the FATE parameters like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left ventricular end end diastolic area.
Read the detailed description
Various haemodynamic parameters like central venous pressure , pulmonary capillary wedge pressure , systolic pulse pressure variations , stroke volume variation , pleth variability index etc are being used as markers of volume status and which in turn have been used as indicators of post general anesthesia induction hypotension in the past . In the current study the investigators aim to validate the role of a bed side 2-D transthoracic echocardiography (TTE) as a guide to identify the volume status of the patient before induction and clinically observe for the haemodynamic changes in the form of mean arterial pressure variations in the immediate post induction period.
The investigators aim to perform preoperative bed side Transthoracic echocardiography in 150 American society of Anesthesiologists grade-I/II patients posted for routine General anaesthesia procedures and assess their volume status . Then the investigators would collect 10 mean arterial pressure recordings at one minute interval in the immediate postinduction period and assess the accuracy of TTE in identifying potential patients at risk of developing post induction hypotension.
- Conditions
- Hypotension
- Being tested
- Pre operative Focus assessed Transthoracic echocardiographic assessment.
- Keywords
- post general anaesthesia induced
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre operative Focus assessed Transthoracic echocardiographic assessment.Other
| Study group | Role | What they receive |
|---|---|---|
| Hypovolemia group | Those patients who are said to be positive for one or more of the following TTE criteria are grouped under this , them being i.IVC diameter of less than 1 cm , ii.Caval index of > 50%, iii.Left ventricular end diastolic area of < 10 cm2 iv. VTI variation with respiration of < 12.5%, are grouped under the hypovolaemia group . Receives: Other: Pre operative Focus assessed Transthoracic echocardiographic assessment. | |
| Normovolaemia group | Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here. Receives: Other: Pre operative Focus assessed Transthoracic echocardiographic assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Role of Transthoracic echocardiography in assessing preoperative volume status using various parameters like Velocity time integral , Inferior vena cava diameter , Caval index , Left Ventricular end diastolic area etc ., in accurately predicting the incidence of hypotension at the time of induction in patients who are being administered general anaesthesia
Measured: January 2016- November 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J S Rahul, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944266
- Sponsor's protocol ID
- NK/2172/MD/11249-50
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
PubMed 16115962Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
PubMed 17122571Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
PubMed 16157727Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
PubMed 19934864Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PubMed 12065368Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.
PubMed 16052125Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.
PubMed 15045170Reuter DA, Felbinger TW, Schmidt C, Kilger E, Goedje O, Lamm P, Goetz AE. Stroke volume variations for assessment of cardiac responsiveness to volume loading in mechanically ventilated patients after cardiac surgery. Intensive Care Med. 2002 Apr;28(4):392-8. doi: 10.1007/s00134-002-1211-z. Epub 2002 Mar 20.
PubMed 11967591Feissel M, Michard F, Mangin I, Ruyer O, Faller JP, Teboul JL. Respiratory changes in aortic blood velocity as an indicator of fluid responsiveness in ventilated patients with septic shock. Chest. 2001 Mar;119(3):867-73. doi: 10.1378/chest.119.3.867.
PubMed 11243970Filipovic M, Seeberger MD, Schneider MC, Schmid M, Pargger H, Hunziker P, Skarvan K. Transthoracic echocardiography for perioperative haemodynamic monitoring. Br J Anaesth. 2000 Jun;84(6):800-3. doi: 10.1093/oxfordjournals.bja.a013596.
PubMed 10895760Jensen MB, Sloth E, Larsen KM, Schmidt MB. Transthoracic echocardiography for cardiopulmonary monitoring in intensive care. Eur J Anaesthesiol. 2004 Sep;21(9):700-7. doi: 10.1017/s0265021504009068.
PubMed 15595582Cowie B. Focused cardiovascular ultrasound performed by anesthesiologists in the perioperative period: feasible and alters patient management. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):450-6. doi: 10.1053/j.jvca.2009.01.018. Epub 2009 Mar 19.
PubMed 19303330American Society of Anesthesiologists and Society of Cardiovascular Anesthesiologists Task Force on Transesophageal Echocardiography. Practice guidelines for perioperative transesophageal echocardiography. An updated report by the American Society of Anesthesiologists and the Society of Cardiovascular Anesthesiologists Task Force on Transesophageal Echocardiography. Anesthesiology. 2010 May;112(5):1084-96. doi: 10.1097/ALN.0b013e3181c51e90. No abstract available.
PubMed 20418689Colreavy FB, Donovan K, Lee KY, Weekes J. Transesophageal echocardiography in critically ill patients. Crit Care Med. 2002 May;30(5):989-96. doi: 10.1097/00003246-200205000-00007.
PubMed 12006793Brienza N, Giglio MT, Marucci M, Fiore T. Does perioperative hemodynamic optimization protect renal function in surgical patients? A meta-analytic study. Crit Care Med. 2009 Jun;37(6):2079-90. doi: 10.1097/CCM.0b013e3181a00a43.
PubMed 19384211
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
- ClinicalTrials.gov ID
- NCT02944266
- Acronym / sponsor ID
- NK/2172/MD/11249-50
- Conditions
- Hypotension
- Keywords
- post general anaesthesia induced
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Oct 2016 (estimated)
- 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.
This is an observational study to evaluate the role of a Bed side Focus assessed Transthoracic Echocardiography (FATE) in identifying the patients at a potential risk of developing hypotension secondary to general anesthesia induction using the FATE parameters like velocity time integral ( VTI ), Inferior venacava diameter , Caval index and Left ventricular end end diastolic area.
Detailed description
Various haemodynamic parameters like central venous pressure , pulmonary capillary wedge pressure , systolic pulse pressure variations , stroke volume variation , pleth variability index etc are being used as markers of volume status and which in turn have been used as indicators of post general anesthesia induction hypotension in the past . In the current study the investigators aim to validate the role of a bed side 2-D transthoracic echocardiography (TTE) as a guide to identify the volume status of the patient before induction and clinically observe for the haemodynamic changes in the form of mean arterial pressure variations in the immediate post induction period.
The investigators aim to perform preoperative bed side Transthoracic echocardiography in 150 American society of Anesthesiologists grade-I/II patients posted for routine General anaesthesia procedures and assess their volume status . Then the investigators would collect 10 mean arterial pressure recordings at one minute interval in the immediate postinduction period and assess the accuracy of TTE in identifying potential patients at risk of developing post induction hypotension.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypovolemia group | – | Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.Those patients who are said to be positive for one or more of the following TTE criteria are grouped under this , them being i.IVC diameter of less than 1 cm , ii.Caval index of > 50%, iii.Left ventricular end diastolic area of < 10 cm2 iv. VTI variation with respiration of < 12.5%, are grouped under the hypovolaemia group . |
| Normovolaemia group | – | Other: Pre operative Focus assessed Transthoracic echocardiographic assessment.Those patients without the above said TTE findings are hypothesised to be normovolaemic and grouped in here. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Any ASA - I/II patient posted for a routine general anaesthesia procedure who is between the age groups 18-60 years, with a BMI between 18-40 , without preexisting haemodynamic instability , sepsis or a documented ventricular dysfunction.
Key inclusion criteria (1 listed)
- Any ASA - I/II patient posted for a routine general anaesthesia procedure and who do not fit with the exclusion criteria.
Key exclusion criteria (6 listed)
- a) Extremes of age <18 years and >60 years
- Sepsis.
- Patients on beta blocking agents.
- Preinduction mean arterial pressure of <70 mm hg.
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 |
|---|---|---|
| Pre operative Focus assessed Transthoracic echocardiographic assessment. | Other | Hypovolemia group, Normovolaemia group |
Primary outcome
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension
Time frame: January 2016- November 2016
Role of Transthoracic echocardiography in assessing preoperative volume status using various parameters like Velocity time integral , Inferior vena cava diameter , Caval index , Left Ventricular end diastolic area etc ., in accurately predicting the incidence of hypotension at the time of induction in patients who are being administered general anaesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 16115962Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.
- Background: PubMed 17122571Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.
- Background: PubMed 16157727Devereaux PJ, Goldman L, Cook DJ, Gilbert K, Leslie K, Guyatt GH. Perioperative cardiac events in patients undergoing noncardiac surgery: a review of the magnitude of the problem, the pathophysiology of the events and methods to estimate and communicate risk. CMAJ. 2005 Sep 13;173(6):627-34. doi: 10.1503/cmaj.050011.
- Background: PubMed 19934864Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
- Background: PubMed 12065368Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
- Background: PubMed 16052125Michard F. Changes in arterial pressure during mechanical ventilation. Anesthesiology. 2005 Aug;103(2):419-28; quiz 449-5. doi: 10.1097/00000542-200508000-00026.
- Background: PubMed 15045170Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.
- Background: PubMed 11967591Reuter DA, Felbinger TW, Schmidt C, Kilger E, Goedje O, Lamm P, Goetz AE. Stroke volume variations for assessment of cardiac responsiveness to volume loading in mechanically ventilated patients after cardiac surgery. Intensive Care Med. 2002 Apr;28(4):392-8. doi: 10.1007/s00134-002-1211-z. Epub 2002 Mar 20.
- Background: PubMed 11243970Feissel M, Michard F, Mangin I, Ruyer O, Faller JP, Teboul JL. Respiratory changes in aortic blood velocity as an indicator of fluid responsiveness in ventilated patients with septic shock. Chest. 2001 Mar;119(3):867-73. doi: 10.1378/chest.119.3.867.
- Background: PubMed 10895760Filipovic M, Seeberger MD, Schneider MC, Schmid M, Pargger H, Hunziker P, Skarvan K. Transthoracic echocardiography for perioperative haemodynamic monitoring. Br J Anaesth. 2000 Jun;84(6):800-3. doi: 10.1093/oxfordjournals.bja.a013596.
- Background: PubMed 15595582Jensen MB, Sloth E, Larsen KM, Schmidt MB. Transthoracic echocardiography for cardiopulmonary monitoring in intensive care. Eur J Anaesthesiol. 2004 Sep;21(9):700-7. doi: 10.1017/s0265021504009068.
- Background: PubMed 19303330Cowie B. Focused cardiovascular ultrasound performed by anesthesiologists in the perioperative period: feasible and alters patient management. J Cardiothorac Vasc Anesth. 2009 Aug;23(4):450-6. doi: 10.1053/j.jvca.2009.01.018. Epub 2009 Mar 19.
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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.
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 Hypotension, run by Post Graduate Institute of Medical Education and Research, Chandigarh 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 1 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahul JS Dr, MD (8437722798, drrahulsamj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focussed Echocardiography to Detect Preoperative Hypovolemia and Left Ventricular Dysfunction as a Predictor of Post-Induction Hypotension (time frame: January 2016- November 2016). 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 NCT02944266, which also lists 21 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 25 Oct 2016.