Cardiac OutputNCT02828176
The Effect of Left Uterine Displacement on Parturient Cardiovascular System
A study testing electric cardiometry, IV line insertion and spinal anesthesia ( subarachnoid block ) in people with Cardiac Output, run by Cairo University.
Trial summary
The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output
- What is being tested?
- electric cardiometry, IV line insertion and spinal anesthesia ( subarachnoid block )
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs
Who cannot join
- BMI > 35 Kg/m2
- polyhydramnios
- history of impaired cardiac contractility
- valvular heart disease
- cardiac arrhythmias
- hypertensive pregnancy disorders
- fetal abnormalities
About this study
Official title: Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females
The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia
Read the detailed description
At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees.
Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome.
After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt).
A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05.
SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.
- Conditions
- Cardiac Output
- Being tested
- electric cardiometry, IV line insertion, spinal anesthesia ( subarachnoid block )
- Keywords
- cardiometry, uterine displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric cardiometryProcedure or surgery
The following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance.
these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )
IV line insertionProcedure or surgery
two Iv lines are inserted and 500cc crystalloid is administered to parturient .
spinal anesthesia ( subarachnoid block )Procedure or surgery
Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.
electric cardiometryProcedure or surgery
after SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees)
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cardiac output (L/min) before anesthesia
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
Measured: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees
change in cardiac output (L/min) after spinal anesthesia
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
Measured: baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees
Secondary outcomes (2)
change in systemic vascular resistance (dyn.s/cm5)
Measured: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block
change in mean arterial blood pressure (mmHg)
measured by oscillometry in mmHg
Measured: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Hassab elnaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828176
- Sponsor's protocol ID
- cardiometry
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. No abstract available.
PubMed 13055188Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553.
PubMed 25603203Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.
PubMed 23543552Hasanin A, Soryal R, Kaddah T, Raouf SA, Abdelwahab Y, Elshafaei K, Elsayad M, Abdelhamid B, Fouad R, Mahmoud D, Hassabelnaby Y. Hemodynamic effects of lateral tilt before and after spinal anesthesia during cesarean delivery: an observational study. BMC Anesthesiol. 2018 Jan 15;18(1):8. doi: 10.1186/s12871-018-0473-0.
PubMed 29334907
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamics Effects of Left Lateral Tilt on the Full Term Pregnant Females
- ClinicalTrials.gov ID
- NCT02828176
- Acronym / sponsor ID
- cardiometry
- Conditions
- Cardiac Output
- Keywords
- cardiometry, uterine displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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.
The aim of the study is to investigate the effect of different angles of lateral tilt on the maternal hemodynamics before and after spinal anesthesia
Detailed description
At operating room, patients will be monitored using non invasive blood, ECG, pulse oximeter and electrical cardiometry. Baseline readings will be taken in supine position then repeated after putting the patient in left lateral position with angle 15 then 30 degrees.
Then two IV lines will be inserted and 500cc crystalloid will be administered. Subarachnoid block will be performed in sitting position under complete aseptic conditions using 25 g spinal needle. Subarachnoid block will be achieved by injecting 10 mg hyperbaric bupivacaine plus 25 ug fentanyl. The block will be considered successful if adequate block reached T4 dermatome.
After successful block the hemodynamic variables will be recorded in the same positions as before (0,15, 30 degrees left uterine tilt).
A minimum number of 61 patients was calculated to have a study power of 80% and alpha error of 0.05.
SPSS Chicago 18 software will be used for data analysis. Categorical data will be presented as frequencies, continuous variables will presented as mean ± standard deviation and will be analyzed using on way analysis of variance (ANOVA) with post-hoc pairwise comparisons using bonferroni test. A P value of 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- full term, singleton, American society of anesthesiologists (ASA) I and II pregnant women scheduled for cs
Key exclusion criteria (7 listed)
- BMI > 35 Kg/m2
- polyhydramnios
- history of impaired cardiac contractility
- valvular heart disease
- cardiac arrhythmias
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 |
|---|---|---|
| electric cardiometryThe following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance. these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees ) | Procedure or surgery | – |
| IV line insertiontwo Iv lines are inserted and 500cc crystalloid is administered to parturient . | Procedure or surgery | – |
| spinal anesthesia ( subarachnoid block )Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome. | Procedure or surgery | – |
| electric cardiometryafter SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees) | Procedure or surgery | – |
Primary outcome
change in cardiac output (L/min) before anesthesia
Time frame: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
change in cardiac output (L/min) after spinal anesthesia
Time frame: baseline after assessing adequate block reaching T4 dermatome then 1 min after left uterine tilt at 15 and 30 degrees
measured by electric cardiometry (ICON; Cardiotonic, Osypka; Berlin, Germany).
2 secondary outcomes
change in systemic vascular resistance (dyn.s/cm5)
Time frame: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block
change in mean arterial blood pressure (mmHg)
Time frame: baseline : 5min after putting the patient in supine position ( at 0, 15, 30 left uterine tilt ). Then 1 min after assuring adequate level of spinal block
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 12 Jul 2016.
- Background: PubMed 13055188HOWARD BK, GOODSON JH, MENGERT WF. Supine hypotensive syndrome in late pregnancy. Obstet Gynecol. 1953 Apr;1(4):371-7. No abstract available.
- Background: PubMed 25603203Higuchi H, Takagi S, Zhang K, Furui I, Ozaki M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Feb;122(2):286-93. doi: 10.1097/ALN.0000000000000553.
- Background: PubMed 23543552Cluver C, Novikova N, Hofmeyr GJ, Hall DR. Maternal position during caesarean section for preventing maternal and neonatal complications. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD007623. doi: 10.1002/14651858.CD007623.pub3.
- Derived from this study: PubMed 29334907Hasanin A, Soryal R, Kaddah T, Raouf SA, Abdelwahab Y, Elshafaei K, Elsayad M, Abdelhamid B, Fouad R, Mahmoud D, Hassabelnaby Y. Hemodynamic effects of lateral tilt before and after spinal anesthesia during cesarean delivery: an observational study. BMC Anesthesiol. 2018 Jan 15;18(1):8. doi: 10.1186/s12871-018-0473-0.
- Individual participant dataSharing planned: Undecided
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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 electric cardiometry, IV line insertion and spinal anesthesia ( subarachnoid block ) in people with Cardiac Output, run by Cairo University.
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 7 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 12 Jul 2016. 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. 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?
change in cardiac output (L/min) before anesthesia (time frame: baseline : 5min after putting the patient in supine position then 1min after left uterine tilt at 15 and 30 degrees). The study lists 2 primary outcomes in all. 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 NCT02828176, which also lists 4 linked publications.
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 12 Jul 2016.