Ignite Creation Date:
2024-05-06 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05143684
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2021-10-24
Brief Title:
Maternal Lateral Tilt and Cardiac Output in Caesarean Section
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Impact of Maternal Lateral Tilt on Cardiac Output During Caesarean Section Under Spinal Anaesthesia A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 T1baseline with LUD T2baseline without LUD T3after SA with LUD T4after 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 dPdt dynamic arterial elastance Eadyn at the different timepoints Data on fetal Apgar scores and umbilical arterial and venous pH were collecte
Methods Forty-six patients were included in the final analysis The investigators considered 4 timepoints of 5 minutes each T1baseline with LUD T2baseline without LUD T3after SA with LUD T4after 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 dPdt dynamic arterial elastance Eadyn at the different timepoints Data on fetal Apgar scores and umbilical arterial and venous pH were collecte
Detailed Description:
The primary outcome was to test if CO decreases significantly after LUD removal in patients under SA for CD This is a prospective observational study
Data were gathered from pregnant patients who in addition to standard monitoring underwent perioperative non-invasive hemodynamic monitoring by ClearSight system on the Edwards Lifesciences HemoSphere platform Edwards Lifesciences Irvine CA
The parameters were recorded at 20 seconds-intervals The investigators considered 4 timepoints T1 were the baseline values recorded for 5 minutes after initial stabilization of parameters with the patient laying down on the operating table with LUD At T2 LUD was removed and we considered for the analysis hemodynamic data of the subsequent 5 minutes The investigators indicated as T3 the 5 minutes following SA with a satisfactory sensory block and as T4 the subsequent 5 minutes following LUD removal Figure 1 summarizes the timepoints of our analysis LUD was accomplished by positioning 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 In all patients after T4 the 15 wooden wedge was positioned again and surgery was performed with LUD
Anesthesia was standard spinal procedure fluid management was left to the attending anesthesiologist
The attending anesthesiologist was blinded to the advanced hemodynamic parameters from the ClearSight system except for the continuous BP values The investigators defined hypotension as an absolute value of MAP 65 mmHg This value was considered as trigger for the attending anesthesiologist for the administration of norepinephrine 5 mcg Norepinephrine boluses were repeated to reach a MAP65mmHg Bradycardia was defined as a heart rate of 60 bpm Atropine 05 mg was administered for the treatment of bradycardia combined with hypotension or for an absolute value of heart rate 45 bpm After delivery Oxytocin was administered to facilitate the uterine contraction
We also evaluated the impact of maternal blood pressure and CO on fetal outcome collecting neonatal Apgar scores at 1 and 5 minutes after birth and umbilical cord arterial and venous pH
Data were gathered from pregnant patients who in addition to standard monitoring underwent perioperative non-invasive hemodynamic monitoring by ClearSight system on the Edwards Lifesciences HemoSphere platform Edwards Lifesciences Irvine CA
The parameters were recorded at 20 seconds-intervals The investigators considered 4 timepoints T1 were the baseline values recorded for 5 minutes after initial stabilization of parameters with the patient laying down on the operating table with LUD At T2 LUD was removed and we considered for the analysis hemodynamic data of the subsequent 5 minutes The investigators indicated as T3 the 5 minutes following SA with a satisfactory sensory block and as T4 the subsequent 5 minutes following LUD removal Figure 1 summarizes the timepoints of our analysis LUD was accomplished by positioning 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 In all patients after T4 the 15 wooden wedge was positioned again and surgery was performed with LUD
Anesthesia was standard spinal procedure fluid management was left to the attending anesthesiologist
The attending anesthesiologist was blinded to the advanced hemodynamic parameters from the ClearSight system except for the continuous BP values The investigators defined hypotension as an absolute value of MAP 65 mmHg This value was considered as trigger for the attending anesthesiologist for the administration of norepinephrine 5 mcg Norepinephrine boluses were repeated to reach a MAP65mmHg Bradycardia was defined as a heart rate of 60 bpm Atropine 05 mg was administered for the treatment of bradycardia combined with hypotension or for an absolute value of heart rate 45 bpm After delivery Oxytocin was administered to facilitate the uterine contraction
We also evaluated the impact of maternal blood pressure and CO on fetal outcome collecting neonatal Apgar scores at 1 and 5 minutes after birth and umbilical cord arterial and venous pH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None