HypotensionNCT02584803
Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views
An observational study of Hypotension and Hypovolemic Shock, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Hypovolemic Shock
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Sep 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Full term pregnant patient coming for elective cesarean section
Who may be able to join
- Adults pregnant females,
- Age 18-45,
- Term pregnancy Parturients not in established labor Singleton pregnancies
Who cannot join
- Advanced labor,
- Multiple gestations,
- Maternal or fetal distress,
- BMI > 45.
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. This study will not involve any change in management of the participating patients.
Read the detailed description
Anesthesiology consultants and trainees with US experience will first perform scans from the RUQ view starting on the mid-axillary line at the T4 intercostal space, looking to obtain a view of the IVC as it enters the right atrium (RA). Following successful acquisition, the examiner will perform scan from the subxiphoid position, looking to obtain the same view of the IVC transitioning into the RA. Primary endpoint will be time to obtaining quality of images. The investigator will use a stopwatch to time acquisition of images. If the duration of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. Each image will be separately reviewed by 2 different US specialists with extensive US experience. Images will be assessed according to a Likert scale from 1 to 5. (Very poor (1), poor (2), acceptable (3), good (4), very good (5)) Secondary endpoints will be assessed as follows: 1. Acceptability: all patients participating in the study will complete a questionnaire to assess acceptability. 2. Comfort: During the exam the patient will have the option to suspend the scan by stating they are uncomfortable and wish to stop. Each request will be noted and taken into the account at data analysis. Furthermore, patients will be given a questionnaire at the end of the scan and asked to rate their comfort level during procedure according to Likert scale. (Very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very uncomfortable (1)) 3. Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5))
- Conditions
- Hypotension, Hypovolemic Shock
- Being tested
- Ultrasound
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
Evaluating the feasibility and efficacy of IVC ultrasound imaging through the RUQ and subxiphoid view in term parturients.
- Patient Acceptability of procedure
- Patient Comfort:
- Ease of exam for the examiner
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to obtaining good Quality IVC images through RUQ and subxiphoid window
Measured: 60 seconds
Secondary outcomes (3)
Patient Acceptability of procedure
Would you agree to have similar ultrasound scans again?
Yes/No
Measured: 10 seconds
patient comfort
Please rate your comfort during the ultrasound scan, on a scale of 1 to 5. Where 5 is very comfortable and 0 is not comfortable
Measured: 10 seconds
Ease of exam for the examiner
Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5)
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startMay 2016
- Primary completionAug 2017
- Study completionSep 2017
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 HypotensionStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indu Singh, Principal investigator, Western University, Schulish school of Medicine, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584803
- Sponsor's protocol ID
- 103637
- Status last verified
- May 2016
- First submitted
- 19 Oct 2015
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dennis A, Arhanghelschi I, Simmons S, Royse C. Prospective observational study of serial cardiac output by transthoracic echocardiography in healthy pregnant women undergoing elective caesarean delivery. Int J Obstet Anesth. 2010 Apr;19(2):142-8. doi: 10.1016/j.ijoa.2009.06.007. Epub 2010 Mar 3.
PubMed 20202818Dennis AT. Transthoracic echocardiography in obstetric anaesthesia and obstetric critical illness. Int J Obstet Anesth. 2011 Apr;20(2):160-8. doi: 10.1016/j.ijoa.2010.11.007. Epub 2011 Feb 18.
PubMed 21315578
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Vena Cava Assessment in Term Pregnancy Using Ultrasound: a Feasibility Study of Subxiphoid and RUQ Views
- ClinicalTrials.gov ID
- NCT02584803
- Acronym / sponsor ID
- 103637
- Conditions
- Hypotension, Hypovolemic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 23 Oct 2015 (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 study is to assess the feasibility of 2 different ultrasound views of the inferior vena cava (IVC), a large vein that returns blood to the heart. Ultrasound is safe in pregnancy and, is regularly used to evaluate the fetus. It is hoped that imaging of the IVC will then allow us to determine the fluid status of the parturient which could be helpful in treating hemodynamic instability. This study will not involve any change in management of the participating patients.
Detailed description
Anesthesiology consultants and trainees with US experience will first perform scans from the RUQ view starting on the mid-axillary line at the T4 intercostal space, looking to obtain a view of the IVC as it enters the right atrium (RA). Following successful acquisition, the examiner will perform scan from the subxiphoid position, looking to obtain the same view of the IVC transitioning into the RA. Primary endpoint will be time to obtaining quality of images. The investigator will use a stopwatch to time acquisition of images. If the duration of scanning exceeds ten minutes, the scan will be discontinued and labeled as failed. Each image will be separately reviewed by 2 different US specialists with extensive US experience. Images will be assessed according to a Likert scale from 1 to 5. (Very poor (1), poor (2), acceptable (3), good (4), very good (5)) Secondary endpoints will be assessed as follows: 1. Acceptability: all patients participating in the study will complete a questionnaire to assess acceptability. 2. Comfort: During the exam the patient will have the option to suspend the scan by stating they are uncomfortable and wish to stop. Each request will be noted and taken into the account at data analysis. Furthermore, patients will be given a questionnaire at the end of the scan and asked to rate their comfort level during procedure according to Likert scale. (Very comfortable (5), comfortable (4), equivocal (3), uncomfortable (2), very uncomfortable (1)) 3. Ease of exam: Examiner will rate the ease of image acquirement according to Likert scale. (impossible (1), difficult (2), equivocal (3), easy (4), very easy (5))
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Full term pregnant patient coming for elective cesarean section
Key inclusion criteria (3 listed)
- Adults pregnant females,
- Age 18-45,
- Term pregnancy Parturients not in established labor Singleton pregnancies
Key exclusion criteria (5 listed)
- Advanced labor,
- Multiple gestations,
- Maternal or fetal distress,
- BMI > 45.
- Inability to obtain informed consent
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 |
|---|---|---|
| UltrasoundEvaluating the feasibility and efficacy of IVC ultrasound imaging through the RUQ and subxiphoid view in term parturients. 1. Patient Acceptability of procedure 2. Patient Comfort: 3. Ease of exam for the examiner | Radiation | – |
Primary outcome
Time to obtaining good Quality IVC images through RUQ and subxiphoid window
Time frame: 60 seconds
3 secondary outcomes
Patient Acceptability of procedure
Time frame: 10 seconds
patient comfort
Time frame: 10 seconds
Ease of exam for the examiner
Time frame: 10 seconds
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 11 Dec 2018.
- Results publication: PubMed 20202818Dennis A, Arhanghelschi I, Simmons S, Royse C. Prospective observational study of serial cardiac output by transthoracic echocardiography in healthy pregnant women undergoing elective caesarean delivery. Int J Obstet Anesth. 2010 Apr;19(2):142-8. doi: 10.1016/j.ijoa.2009.06.007. Epub 2010 Mar 3.
- Results publication: PubMed 21315578Dennis AT. Transthoracic echocardiography in obstetric anaesthesia and obstetric critical illness. Int J Obstet Anesth. 2011 Apr;20(2):160-8. doi: 10.1016/j.ijoa.2010.11.007. Epub 2011 Feb 18.
- Individual participant dataSharing planned: Undecided
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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.
Indu Singh principal investigator
Western University, Schulish school of Medicine, Department of Anesthesia
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 and Hypovolemic Shock, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 11 Dec 2018. 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 Canada. 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?
Time to obtaining good Quality IVC images through RUQ and subxiphoid window (time frame: 60 seconds). 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 NCT02584803, 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 11 Dec 2018.