Cesarean Section ComplicationsNCT03170427
Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section
A study testing Impedance cardiography, Sensory levels and Motor block in people with Cesarean Section Complications, run by University of Foggia.
Trial summary
Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Impedance cardiography, Sensory levels and Motor block
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 May 2014
- Phase
- Interventional
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant undergoing elective Caesarean delivery at term of singleton pregnancy, with American Society of Anesthesiologists physical status of class I or II, without preeclampsia or diabetes,
Who cannot join
- Patient with a known allergy to amide local anesthetics and other drugs, with BMI≥40 kg/m2, cardiologic or systemic disease, in treatment with antihypertensive or anticoagulant
About this study
Official title: Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study
Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to compare the duration and quality of analgesia and anesthesia
Read the detailed description
On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on the left arm, two sensors will be placed above the clavicle on each side of the neck, and two sensors will bw placed on either side of the thorax at midaxillary line corresponding to the level of the xiphoid process. Using a computer- generated sequence of numbers, patients will be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a 18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural space.
- Conditions
- Cesarean Section Complications
- Being tested
- Impedance cardiography, Sensory levels, Motor block, Sensory level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance cardiographyDevice
hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine
Sensory levelsDiagnostic test
Sensory levels are checked using ice test cold
Motor blockDiagnostic test
motor block is measured by modified Bromage scale
Sensory levelDiagnostic test
Sensory levels are checked using touch with alcohol puffs
| Study group | Role | What they receive |
|---|---|---|
| 8 mg (2 mL) levobupivacaine | Sham comparator | 8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored Receives: Device: Impedance cardiography; Diagnostic Test: Sensory levels; Diagnostic Test: Motor block; Diagnostic Test: Sensory level |
| 6 mg (1.6 mL) levobupivacaine | Active comparator | 6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored Receives: Device: Impedance cardiography; Diagnostic Test: Sensory levels; Diagnostic Test: Motor block; Diagnostic Test: Sensory level |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic continuous monitoring by impedance cardiography
Impedance cardiography as a tool for hemodynamic monitoring during cesarean section
Measured: intraoperative time
Secondary outcomes (4)
onset of sensory block
onset time of sensory block after intrathecal levobupivacaine
Measured: intraoperative time
offset of sensory block
offset time of sensory block after intrathecal levobupivacaine
Measured: intraoperative time
onset of motor block
onset time of motor block after intrathecal levobupivacaine
Measured: intraoperative time
offset of motor block
offset time of motor block after intrathecal levobupivacaine
Measured: intraoperative time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jan 2013
- Primary completion1 Jan 2014
- Study completion31 May 2014
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 Cesarean Section ComplicationsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170427
- Sponsor's protocol ID
- 18/CE/2012
- Status last verified
- Oct 2017
- First submitted
- 23 May 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
D'Ambrosio A, Cotoia A, Beck R, Salatto P, Zibar L, Cinnella G. Impedance cardiography as tool for continuous hemodynamic monitoring during cesarean section: randomized, prospective double blind study. BMC Anesthesiol. 2018 Mar 27;18(1):32. doi: 10.1186/s12871-018-0498-4.
PubMed 29587655
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Cardiography as Tool for Continuous Hemodynamic Monitoring During Cesarean Section: Randomized, Prospective Double Blind Study
- ClinicalTrials.gov ID
- NCT03170427
- Acronym / sponsor ID
- 18/CE/2012
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 31 May 2017 (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.
Impedance Cardiography (ICG) is a non-invasive tool for continuous hemodynamic monitoring. Aims of our study is to assess the utility of ICG to evaluate the hemodynamic impact of 6 mg (GL6) vs 8 mg (GL8) levobupivacaine combined with fentanyl in healthy patients undergoing elective cesarean section; secondary, to compare the duration and quality of analgesia and anesthesia
Detailed description
On arrival in the recovery room the ICG non-invasive blood pressure cuff will be placed on the left arm, two sensors will be placed above the clavicle on each side of the neck, and two sensors will bw placed on either side of the thorax at midaxillary line corresponding to the level of the xiphoid process. Using a computer- generated sequence of numbers, patients will be randomly allocated in one of the two groups: 6 mg (1.6 mL) levobupivacaine + 20 µg fentanyl (GL6 group) or 8 mg (2 mL) levobupivacaine + 20 µg fentanyl (GL8 group). Continuous spinal epidural anesthesia (CSE) will be performed with patient in sitting position: a 18-gauge Tuohy needle will be inserted into the L2-L3 interspace using the loss of resistance of saline technique to identify the epidural space; a 27-gauge Withacre spinal needle will be then placed through the Tuohy needle until the dura mater wwill be punctured and isobaric undiluted levobupivacaine plus 20 µg fentanyl was administered. Afterwards, an epidural catheter (Espocan, B.Braun, Melsungen, Germany) wwill be inserted 4 cm into the epidural space.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8 mg (2 mL) levobupivacaine | Sham comparator | Device: Impedance cardiography, Diagnostic Test: Sensory levels, Diagnostic Test: Motor block, Diagnostic Test: Sensory level8mg (2ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored |
| 6 mg (1.6 mL) levobupivacaine | Active comparator | Device: Impedance cardiography, Diagnostic Test: Sensory levels, Diagnostic Test: Motor block, Diagnostic Test: Sensory level6mg (1.6ml) levobupivacaine plus 20 µg fentanyl will be given intrathecally by spinal anesthesia. The impendance cardiography, the sensory and motor block will be monitored |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant undergoing elective Caesarean delivery at term of singleton pregnancy, with American Society of Anesthesiologists physical status of class I or II, without preeclampsia or diabetes,
Key exclusion criteria (1 listed)
- Patient with a known allergy to amide local anesthetics and other drugs, with BMI≥40 kg/m2, cardiologic or systemic disease, in treatment with antihypertensive or anticoagulant
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 |
|---|---|---|
| Impedance cardiographyhemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine | Device | 6 mg (1.6 mL) levobupivacaine, 8 mg (2 mL) levobupivacaine |
| Sensory levelsSensory levels are checked using ice test cold | Diagnostic test | 6 mg (1.6 mL) levobupivacaine, 8 mg (2 mL) levobupivacaine |
| Motor blockmotor block is measured by modified Bromage scale | Diagnostic test | 6 mg (1.6 mL) levobupivacaine, 8 mg (2 mL) levobupivacaine |
| Sensory levelSensory levels are checked using touch with alcohol puffs | Diagnostic test | 6 mg (1.6 mL) levobupivacaine, 8 mg (2 mL) levobupivacaine |
Primary outcome
hemodynamic continuous monitoring by impedance cardiography
Time frame: intraoperative time
Impedance cardiography as a tool for hemodynamic monitoring during cesarean section
4 secondary outcomes
onset of sensory block
Time frame: intraoperative time
offset of sensory block
Time frame: intraoperative time
onset of motor block
Time frame: intraoperative time
offset of motor block
Time frame: intraoperative time
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 23 Oct 2017.
- Derived from this study: PubMed 29587655D'Ambrosio A, Cotoia A, Beck R, Salatto P, Zibar L, Cinnella G. Impedance cardiography as tool for continuous hemodynamic monitoring during cesarean section: randomized, prospective double blind study. BMC Anesthesiol. 2018 Mar 27;18(1):32. doi: 10.1186/s12871-018-0498-4.
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
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Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Impedance cardiography, Sensory levels and Motor block in people with Cesarean Section Complications, run by University of Foggia.
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 1 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
hemodynamic continuous monitoring by impedance cardiography (time frame: intraoperative time). 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 NCT03170427, 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 23 Oct 2017.