Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension

NCT03653442 | Completed

• 1 other identifier: Reg. 2018/0051
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension, Controlled; Anaesthesia, Spinal; Caesarean Section

Keywords

Induced hypotension; Spinal Anaesthesia; Elective Caesarean section; non-invasive haemodynamic parameters

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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)

  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)

  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)

  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)

  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)

  before Caesarean section

Secondary Outcomes (1)

• Neuraxial induced hypotension

  from immediately after induction of spinal anaesthesia to 15 minutes later

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy pregnant women admitted in the enrolling Centre to undergo to elective Caesarean section under spinal anaesthesia

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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)

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Asst Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chiara Viviani, M.D.

  ASST Papa Giovanni XXIII, Bergamo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: August 31, 2018
• Study Start: June 10, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

IT (1)