SpinalNCT03319433
Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section
An observational study of Spinal and Hypotension, run by Paropakar Maternity and Women's Hospital.
Trial summary
Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Spinal, Hypotension, Perfusion Index
- What is being tested?
- Perfusion Index
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 15 Nov 2018
- 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 20 to 35 years
- Women only
- Adult
Study population: Parturient presenting to Paropakar Maternity and Women's Hospital for elective caesarean section.
Who may be able to join
- ASA II physical status.
- Planned for elective LSCS
- Gestational age >36 weeks and <41 weeks
Who cannot join
- Patient's refusal.
- Emergency LSCS.
- Patient's with contraindications to spinal anesthesia
- Patient with BMI >40, preeclampsia, placenta praevia.
- Patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes.
About this study
Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over.
Perfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. This is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. During normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia.
Thus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.
- Conditions
- Spinal, Hypotension, Perfusion Index
- Being tested
- Perfusion Index
- Keywords
- spinal hypotension, perfusion index, caesarean section
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion IndexDevice
Use of non-invasive pulse oximeter to determine perfusion index
| Study group | Role | What they receive |
|---|---|---|
| Group I (Perfusion Index <3.5) | Those parturient with perfusion index <3.5 when baseline monitors are attached while the patient is being prepared for surgery. Receives: Device: Perfusion Index | |
| Group II (Perfusion index >3.5) | Those parturient with perfusion index >3.5 when baseline monitors are attached while the patient is being prepared for surgery. Receives: Device: Perfusion Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.
Measured: 3 months
Secondary outcomes (5)
Perfusion index
To compare the perfusion index (PI) at various intervals between the two groups
Measured: 3 months
Side-effects
To study the profile of side effects between the two groups.
Measured: 3 months
Systolic blood pressure
To compare the systolic blood pressure (SBP) at various intervals between the two groups.
Measured: 3 months
Diastolic blood pressure
To compare the diastolic blood pressure (DBP) at various intervals between the two groups.
Measured: 3 months
Mean arterial pressure
To compare the mean arterial pressure (MAP) at various intervals between the two groups
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 May 2018 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion15 Nov 2018 (estimated)
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 SpinalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paropakar Maternity and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Achyut Sharma, Paropakar Maternity and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319433
- Sponsor's protocol ID
- ParopakarMWH
- Status last verified
- Apr 2018
- First submitted
- 19 Oct 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soma-Pillay P, Nelson-Piercy C, Tolppanen H, Mebazaa A. Physiological changes in pregnancy. Cardiovasc J Afr. 2016 Mar-Apr;27(2):89-94. doi: 10.5830/CVJA-2016-021.
PubMed 27213856Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.
PubMed 28976555Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.
PubMed 25610851Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
PubMed 28890560
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia in Lower Segment Caesarean Section
- ClinicalTrials.gov ID
- NCT03319433
- Acronym / sponsor ID
- ParopakarMWH
- Conditions
- Spinal, Hypotension, Perfusion Index
- Keywords
- spinal hypotension, perfusion index, caesarean section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Paropakar Maternity and Women's HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 24 Oct 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.
Spinal anesthesia for caesarean section is invariably associated with variable degree of hypotension. Hypotension that occurs may be detrimental to various organ system due to inadequate perfusion. Various methods and agents have been tried in order to address this problem. However, this calamity is far from over.
Perfusion index is one such attempt to address the problem of hypotension by predicting which group of parturient may develop hypotension. This is a type of non-invasive method of assessing the relative vascular tone with the use of pulse oximeter which calculates the ration of pulsatile versus the non-pulsatile component of the blood flow. During normal physiological changes in pregnancy, there is relative loss of vascular tone which predisposes this group of patient to sudden development of hypotension after the sympathetic block due to spinal anesthesia.
Thus, the aim of the study is to use the non-invasive perfusion index data to predict the occurrence of hypotension in a parturient so that helps us to guide fluid and other drug therapy to address the problem of hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Perfusion Index <3.5) | – | Device: Perfusion IndexThose parturient with perfusion index <3.5 when baseline monitors are attached while the patient is being prepared for surgery. |
| Group II (Perfusion index >3.5) | – | Device: Perfusion IndexThose parturient with perfusion index >3.5 when baseline monitors are attached while the patient is being prepared for surgery. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Parturient presenting to Paropakar Maternity and Women's Hospital for elective caesarean section.
Key inclusion criteria (3 listed)
- ASA II physical status.
- Planned for elective LSCS
- Gestational age >36 weeks and <41 weeks
Key exclusion criteria (5 listed)
- Patient's refusal.
- Emergency LSCS.
- Patient's with contraindications to spinal anesthesia
- Patient with BMI >40, preeclampsia, placenta praevia.
- Patients with comorbidities like cerebrovascular or cardiovascular disease, and gestational diabetes.
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 |
|---|---|---|
| Perfusion IndexUse of non-invasive pulse oximeter to determine perfusion index | Device | Group I (Perfusion Index <3.5), Group II (Perfusion index >3.5) |
Primary outcome
Incidence of hypotension
Time frame: 3 months
compare the incidence of hypotension following SAB for LSCS in parturient with or without a high perfusion index.
5 secondary outcomes
Perfusion index
Time frame: 3 months
Side-effects
Time frame: 3 months
Systolic blood pressure
Time frame: 3 months
Diastolic blood pressure
Time frame: 3 months
Mean arterial pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Results publication: PubMed 27213856Soma-Pillay P, Nelson-Piercy C, Tolppanen H, Mebazaa A. Physiological changes in pregnancy. Cardiovasc J Afr. 2016 Mar-Apr;27(2):89-94. doi: 10.5830/CVJA-2016-021.
- Results publication: PubMed 28976555Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.
- Results publication: PubMed 25610851Nag DS, Samaddar DP, Chatterjee A, Kumar H, Dembla A. Vasopressors in obstetric anesthesia: A current perspective. World J Clin Cases. 2015 Jan 16;3(1):58-64. doi: 10.12998/wjcc.v3.i1.58.
- Results publication: PubMed 28890560Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.
Related trials for Spinal
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
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?
An observational study of Spinal and Hypotension, run by Paropakar Maternity and Women's Hospital.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. 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?
Results are not available in the source record.
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?
Incidence of hypotension (time frame: 3 months). 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 NCT03319433, 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 11 Apr 2018.