Hypotension Drug-InducedNCT05143684
Maternal Lateral Tilt and Cardiac Output in Caesarean Section
An observational study of Hypotension Drug-Induced, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Left Lateral Uterine Displacement
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 31 Jul 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective caesarean section under spinal anesthesia at IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Who may be able to join
- pregnant patients at term (36th to 40th week of gestation) scheduled for elective caesarean section under spinal anesthesia.
Who cannot join
- 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
Show all 11Show fewer
- foetal complications
- coagulation disorders or contraindication to neuraxial block
- emergency surgery
- preoperative infection
- patient's refusal
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Rome, 00168
About this study
Official title: Impact of Maternal Lateral Tilt on Cardiac Output During Caesarean Section Under Spinal Anaesthesia: A Prospective Observational Study
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
Read the 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 MAP>65mmHg. Bradycardia was defined as a heart rate of < 60 bpm. Atropine 0.5 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.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Left Lateral Uterine Displacement
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Lateral Uterine DisplacementProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: at 5 minutes from left lateral uterine tilt removal under spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Jun 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypotension Drug-InducedStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SONNINO CHIARA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Gaetano A Draisci, MD, Study director, IRCCS Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143684
- Sponsor's protocol ID
- LUD-CS
- Status last verified
- Nov 2021
- First submitted
- 24 Oct 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35410115
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Lateral Tilt on Cardiac Output During Caesarean Section Under Spinal Anaesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05143684
- Acronym / sponsor ID
- LUD-CS
- Conditions
- Hypotension Drug-Induced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 3 Dec 2021 (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.
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
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 MAP>65mmHg. Bradycardia was defined as a heart rate of < 60 bpm. Atropine 0.5 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective caesarean section under spinal anesthesia at IRCCS Fondazione Policlinico Universitario Agostino Gemelli
Key inclusion criteria (1 listed)
- pregnant patients at term (36th to 40th week of gestation) scheduled for elective caesarean section under spinal anesthesia.
Key exclusion criteria (11 listed)
- age <18 years
- American Society of Anesthesiologists score >3
- cardiac arrhythmias or aortic regurgitation
- pregnancy-induced hypertension
- pre-eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Lateral Uterine Displacementa 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 | Procedure or surgery | – |
Primary outcome
Cardiac Output (l/min) measured by non-invasive hemodynamic monitoring
Time frame: at 5 minutes from left lateral uterine tilt removal under spinal anesthesia
Does cardiac output decrease significantly after left lateral uterine displacement removal in patients under spinal anesthesia for caesarean delivery?
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 3 Dec 2021.
- Derived from this study: PubMed 35410115Sonnino 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hypotension Drug-Induced
RecruitingPhase 4
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Hypotension Drug-Induced
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
Not yet recruiting
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
Hypotension Drug-Induced, Spinal Aneshtesia
Recruiting
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
Paracetamol, Hypotension Drug-Induced
RecruitingPhase 2/3
Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
Post Operative Analgesia, Bradycardia
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.
Gaetano A Draisci, MD study director
IRCCS Fondazione Policlinico Universitario Agostino Gemelli
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 Drug-Induced, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 1 inclusion and 11 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 3 Dec 2021. 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?
Cardiac Output (l/min) measured by non-invasive hemodynamic monitoring (time frame: at 5 minutes from left lateral uterine tilt removal under spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05143684, which also lists 1 linked publication.
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 3 Dec 2021.