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Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension (NIHNAH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653442
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Chiara Viviani, Papa Giovanni XXIII Hospital

Brief 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.

Condition or disease
Hypotension, Controlled Anaesthesia, Spinal Caesarean Section

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.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Haemodynamic Parameters Predictive of Hypotension Induced by Neuraxial Anaesthesia During Elective Caesarean Section
Actual Study Start Date : June 10, 2018
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)


Secondary Outcome Measures :
  1. Neuraxial induced hypotension [ Time Frame: from immediately after induction of spinal anaesthesia to 15 minutes later ]
    Neuraxial induced hypotension is defined as a reduction of SBP < 100 mmHg or a decrease by 20 - 30%, compared to basal value



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean section under spinal anaesthesia
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
    • Other maternal organ dysfunction:

      1. 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),
      2. 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),
      3. 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),
      4. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653442


Locations
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Italy
Asst Papa Giovanni Xxiii
Bergamo, Italy, 24127
Sponsors and Collaborators
Papa Giovanni XXIII Hospital
Investigators
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Principal Investigator: Chiara Viviani, M.D. ASST Papa Giovanni XXIII, Bergamo, Italy

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Responsible Party: Chiara Viviani, Principal Investigator, Papa Giovanni XXIII Hospital
ClinicalTrials.gov Identifier: NCT03653442    
Other Study ID Numbers: Reg. 2018/0051
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Chiara Viviani, Papa Giovanni XXIII Hospital:
Induced hypotension
Spinal Anaesthesia
Elective Caesarean section
non-invasive haemodynamic parameters
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs