Hypotension, ControlledNIHNAHNCT03653442
Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension
An observational study of Hypotension, Controlled and Anaesthesia, Spinal, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypotension, Controlled, Anaesthesia, Spinal, Caesarean Section
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2018to 1 Jan 2020
- 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: Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean section under spinal anaesthesia
Who may be able to join
- Pregnant women with high bleeding risk (previous caesarean section, previous uterine surgery, placenta praevia/accrete, previous documented uterine atony, foetal macrosomia, polyhydramnios)
- Obstetric nulliparous or multiparous patients
- Spontaneous pregnancy
- Single foetus, at term
- Elective Caesarean section, fasting according to international guidelines
- At term BMI > 18 and < 35 kg/m2
Who cannot join
- Contraindications to neuraxial anaesthesia
- Previous documented maternal cardiovascular problems
- Gestational hypertension (defined as new onset systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two occasions at east 4 - 6 hours apart while the patient is on bed rest, with an appropriately sized cuff, after 20 weeks gestation)
- Chronic hypertension of any causes (defined as systemic blood pressure > 140/90 mmHg)
- Preeclampsia (defined as gestational hypertension with one or more of the following de novo conditions:
- Proteinuria (defined as the excretion of 300 mg or more of protein in a 24-hour urine collection or a protein/creatinine ratio of at least 0.3 (each measured as mg/dL) or at least 1 g/L [2+] on dipstick testing)
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- Other maternal organ dysfunction:
- progressive renal insufficiency (renal creatinine concentration greater than 1.1 mg/dL or a doubling of the serum creatinine concentration in the absence of other renal disease),
- impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (at least twice upper limit of normal concentration), severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnoses, or both),
- new-onset cerebral or visual disturbances (examples include eclampsia, altered mental status, blindness, stroke, or more commonly hyperreflexia when accompanied by clonus, severe headaches when accompanied by hyperreflexia, persistent visual scotoma),
- haematological complications (thrombocytopenia - platelet count below 150,000/dL, disseminated intravascular coagulation (DIC), haemolysis).
- Uteroplacental dysfunction with foetal growth restriction (less than fifth percentile)
- Reversed end-diastolic flow on umbilical artery Doppler studies (IR > 0,5 at 24 week gestation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Haemodynamic Parameters Predictive of Hypotension Induced by Neuraxial Anaesthesia During Elective Caesarean Section
Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications.
Read the detailed description
Hypotension induced by neuraxial anaesthesia (NA-induced hypotension) is defined as systolic blood pressure (SBP) less than 100 mmHg or a decrease of 20-30% from baseline values. The incidence of hypotension could exceed 71% and can cause, if serious and prolonged, nausea, vomiting, lost of consciousness, placental hypoperfusion and foetal acidosis.
There are two alternative hypotheses to explain why hypotension might be so commonly diagnosed after regional analgesia during labour: preload reduction theory and afterload reduction theory. A non-invasive continue haemodynamic monitoring could be useful in detecting pregnant women with a positive preoperative supine stress, at increased risk for clinically significant hypotension during Caesarean section under spinal anaesthesia. These women seem more likely to benefit from optimizing the administration of fluids and vasoconstrictors to maintain pressure and cardiac output at basal levels.
Predictors of clinical need of therapy to counteract symptomatic hypotension (dependant variable) will be sought by using regression logistic analysis. Putative variable to include in the model will be selected through clinical and statistical criteria. Univariate screening will be performed assuming the usual cut-off of p<0,1 and taking into account the biological relevance. The final variable to challenge in the multivariate model will be selected according to the parsimony criteria in order to avoid overfitting and multicollinearity.
- Keywords
- Induced hypotension, Spinal Anaesthesia, Elective Caesarean section, non-invasive haemodynamic parameters
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress tests and Systolic blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Diastolic blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Diastolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Mean arterial blood pressure
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Mean arterial blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Heart rate
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Heart rate in beats per minute) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Cardiac output
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Cardiac output in L/min) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Stroke volume
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Stroke volume in mL/beat) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Stress tests and Systemic vascular resistance
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systemic vascular resistance in dynes - sec/cm^5) and neuraxial anaesthesia induced hypotension (clinical end point)
Measured: before Caesarean section
Secondary outcomes (1)
Neuraxial induced hypotension
Neuraxial induced hypotension is defined as a reduction of SBP < 100 mmHg or a decrease by 20 - 30%, compared to basal value
Measured: from immediately after induction of spinal anaesthesia to 15 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start10 Jun 2018
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension, ControlledStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Viviani, Papa Giovanni XXIII Hospital
- Investigators
- Chiara Viviani, M.D., Principal investigator, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653442
- Sponsor's protocol ID
- Reg. 2018/0051
- Acronym
- NIHNAH
- Status last verified
- Mar 2020
- First submitted
- 14 May 2018
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Haemodynamic Parameters Predictive of Hypotension Induced by Neuraxial Anaesthesia During Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT03653442
- Acronym / sponsor ID
- NIHNAH / Reg. 2018/0051
- Keywords
- Induced hypotension, Spinal Anaesthesia, Elective Caesarean section, non-invasive haemodynamic parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 31 Aug 2018 (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.
Spinal (or neuraxial) anaesthesia is still considered the first choice technique for elective Caesarean section as simple, quick, reliable and cheap. However, this anaesthetic method can be burdened by maternal hypotension with significant maternal and foetal implications.
Detailed description
Hypotension induced by neuraxial anaesthesia (NA-induced hypotension) is defined as systolic blood pressure (SBP) less than 100 mmHg or a decrease of 20-30% from baseline values. The incidence of hypotension could exceed 71% and can cause, if serious and prolonged, nausea, vomiting, lost of consciousness, placental hypoperfusion and foetal acidosis.
There are two alternative hypotheses to explain why hypotension might be so commonly diagnosed after regional analgesia during labour: preload reduction theory and afterload reduction theory. A non-invasive continue haemodynamic monitoring could be useful in detecting pregnant women with a positive preoperative supine stress, at increased risk for clinically significant hypotension during Caesarean section under spinal anaesthesia. These women seem more likely to benefit from optimizing the administration of fluids and vasoconstrictors to maintain pressure and cardiac output at basal levels.
Predictors of clinical need of therapy to counteract symptomatic hypotension (dependant variable) will be sought by using regression logistic analysis. Putative variable to include in the model will be selected through clinical and statistical criteria. Univariate screening will be performed assuming the usual cut-off of p<0,1 and taking into account the biological relevance. The final variable to challenge in the multivariate model will be selected according to the parsimony criteria in order to avoid overfitting and multicollinearity.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean section under spinal anaesthesia
Key inclusion criteria (6 listed)
- Pregnant women with high bleeding risk (previous caesarean section, previous uterine surgery, placenta praevia/accrete, previous documented uterine atony, foetal macrosomia, polyhydramnios)
- Obstetric nulliparous or multiparous patients
- Spontaneous pregnancy
- Single foetus, at term
- Elective Caesarean section, fasting according to international guidelines
Key exclusion criteria (13 listed)
- Contraindications to neuraxial anaesthesia
- Previous documented maternal cardiovascular problems
- Gestational hypertension (defined as new onset systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg on two occasions at east 4 - 6 hours apart while the patient is on bed rest, with an appropriately sized cuff, after 20 weeks gestation)
- Chronic hypertension of any causes (defined as systemic blood pressure > 140/90 mmHg)
- Preeclampsia (defined as gestational hypertension with one or more of the following de novo conditions:
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
Stress tests and Systolic blood pressure
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Diastolic blood pressure
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Diastolic blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Mean arterial blood pressure
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Mean arterial blood pressure in mmHg) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Heart rate
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Heart rate in beats per minute) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Cardiac output
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Cardiac output in L/min) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Stroke volume
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Stroke volume in mL/beat) and neuraxial anaesthesia induced hypotension (clinical end point)
Stress tests and Systemic vascular resistance
Time frame: before Caesarean section
to identify correlations among stress tests (supine, deep breath in supine, left lateral, deep breath in left lateral, standing, deep breath in standing, leg raising), non-invasive haemodynamic parameter detected (Systemic vascular resistance in dynes - sec/cm^5) and neuraxial anaesthesia induced hypotension (clinical end point)
1 secondary outcome
Neuraxial induced hypotension
Time frame: from immediately after induction of spinal anaesthesia to 15 minutes later
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 4 Mar 2020.
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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.
Chiara Viviani, M.D. principal investigator
A.O. Ospedale Papa Giovanni XXIII
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, Controlled and Anaesthesia, Spinal, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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 6 inclusion and 13 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 4 Mar 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 Italy. 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?
Stress tests and Systolic blood pressure (time frame: before Caesarean section). The study lists 7 primary outcomes in all. 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 4 Mar 2020.