Hypotension Clinical Trial
Official title:
Prevention of Maternal Hypotension During Elective Caesarean Section Performed With Spinal Anaesthesia, Through Intermittent Pneumatic Compression System in the Lower Extremities.
Verified date | February 2016 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
The hypotension defined as 20 % less than the basal SBP (systolic blood pressure)and / or an
absolute value <90-100 mmHg, he presents an incident of 80-85% after an anesthesia
intradural in the pregnant women, fact that worries for provoking undesirable effects so
much in the mother and as in the fetus /newborn baby.
The purpose of this study is to determine the effectiveness of intermittent pneumatic
compression system in the lower extremities in order to reduce the vasopressors drugs
requirements to maintain hemodynamic stability in pregnant women undergoing elective
caesarean sections with an spinal anaesthesia.
Status | Completed |
Enrollment | 120 |
Est. completion date | September 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women over 18 years scheduled for elective caesarean section in the third quarter of the pregnancy. Inform Consent signed. Exclusion Criteria: - Caesarean section urgent / emergent - Caesarean section with epidural anaesthesia - Caesarean section of multiple pregnancies - Obstetric Pathology: Preeclampsia, Eclampsia, HELLP syndrome (Hemolysis Elevated Liver enzymes Low Platelet count), Small for gestational age (SGA), preterm (<32 weeks) - Valvular heart disease and / or ischemic - High blood pressure diagnosed and in treatment. - Sepsis - Morbid obesity (BMI> 40) - Insulin-dependent diabetes - Block level achieved with spinal anaesthesia> T5 - Patients that can not meet the study protocol |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Vall d'Hebron Hospital | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The dose of needed vasopressor (phenylephrine). | From the beginning of caesaria section (usually from 32 to 42 weeks of pregnancy) until the end of the surgery. | Yes | |
Secondary | Effectiveness of Intermittent pneumatic compression system in order to decrease requirements of vasopressors (Phenylephrine). | Intermittent pneumatic compression system in order to minimise the number of episodes defined as Postoperative nausea and vomiting (POVN) and dizziness associated with hypotension. | From the beginning of caesaria section untill discharge of the recovery room ( a maximum of 4 hours). | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062994 -
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
|
||
Active, not recruiting |
NCT02016599 -
Effects of Transitional Circulation in ELBW Infants
|
||
Recruiting |
NCT05836610 -
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
|
Phase 4 | |
Completed |
NCT03215797 -
Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
|
Phase 3 | |
Suspended |
NCT02315937 -
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
|
N/A | |
Completed |
NCT02907931 -
Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status
|
N/A | |
Recruiting |
NCT02532270 -
Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
|
N/A | |
Completed |
NCT02437799 -
Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia
|
N/A | |
Completed |
NCT02802683 -
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
|
Phase 4 | |
Not yet recruiting |
NCT01941472 -
Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness
|
N/A | |
Completed |
NCT01930227 -
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients
|
N/A | |
Completed |
NCT02146898 -
The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery
|
N/A | |
Recruiting |
NCT01434251 -
Treatment of Hypotension of Prematurity (TOHOP)
|
N/A | |
Completed |
NCT01592669 -
Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia
|
N/A | |
Withdrawn |
NCT01183741 -
Accuracy of Non-Invasive Blood Pressure Measurement in Adults
|
Phase 3 | |
Completed |
NCT00991627 -
Different Approaches to Maternal Hypotension During Cesarean Section
|
Phase 4 | |
Withdrawn |
NCT00750516 -
Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
|
||
Completed |
NCT00115726 -
Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure
|
Phase 4 | |
Recruiting |
NCT05513066 -
Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
|
||
Completed |
NCT04089644 -
Manual vs Closed-loop Control of Mean Arterial Pressure
|
N/A |