Maternal Lateral Tilt and Cardiac Output in Caesarean Section

NCT05143684 | Completed

• 1 other identifier: LUD-CS
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Left uterine displacement (LUD) has been questioned as an effective strategy to prevent aortocaval compression after spinal anesthesia (SA) for cesarean delivery (CD). The investigators tested if LUD has a significant impact on cardiac output (CO) in patients undergoing CD under SA during continuous non-invasive hemodynamic monitoring. Methods: Forty-six patients were included in the final analysis. The investigators considered 4 timepoints of 5 minutes each: T1=baseline with LUD; T2=baseline without LUD; T3=after SA with LUD; T4=after SA without LUD. LUD was then repositioned for CD. Primary outcome was to test if CO decreased from T3 to T4. We also compared CO between T1 and T2 and other hemodynamic variables: mean, systolic and diastolic blood pressure (respectively MAP, SAP and DAP), heart rate (HR), stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PPV), contractility (dP/dt), dynamic arterial elastance (Eadyn) at the different timepoints. Data on fetal Apgar scores and umbilical arterial and venous pH were collecte

Conditions

Hypotension Drug-Induced

Outcome Measures

Primary Outcomes (1)

• Cardiac Output (l/min) measured by non-invasive hemodynamic monitoring

  Does cardiac output decrease significantly after left lateral uterine displacement removal in patients under spinal anesthesia for caesarean delivery?

  at 5 minutes from left lateral uterine tilt removal under spinal anesthesia

Interventions

Left Lateral Uterine Displacement PROCEDURE

a wooden wedge wrapped with cotton, to make it comfortable, and medical sheets with a measured angle of 15° under the right flank of the laying down patient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study only involves female pregnant patients at term scheduled for elective caesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective caesarean section under spinal anesthesia at IRCCS Fondazione Policlinico Universitario Agostino Gemelli

You may qualify if:

• pregnant patients at term (36th to 40th week of gestation) scheduled for elective caesarean section under spinal anesthesia.

You may not qualify if:

• age \<18 years
• American Society of Anesthesiologists score \>3
• cardiac arrhythmias or aortic regurgitation
• pregnancy-induced hypertension
• pre-eclampsia
• body mass index (BMI) \> 35 kg/m2
• foetal complications
• coagulation disorders or contraindication to neuraxial block
• emergency surgery
• preoperative infection
• patient's refusal

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Fondazione Policlinico Universitario Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

• Sonnino C, Frassanito L, Piersanti A, Giuri PP, Zanfini BA, Catarci S, Draisci G. Impact of maternal lateral tilt on cardiac output during caesarean section under spinal anaesthesia: a prospective observational study. BMC Anesthesiol. 2022 Apr 11;22(1):103. doi: 10.1186/s12871-022-01640-6.

  PMID: 35410115 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gaetano A Draisci, MD

  IRCCS Fondazione Policlinico Universitario Agostino Gemelli

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Anesthesiologist

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: December 3, 2021
• Study Start: June 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

IT (1)