Obstetric Anesthesia ProblemsNCT05269407
The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section
An observational study of Obstetric Anesthesia Problems, run by Cairo University at 1 site in Egypt.
Trial summary
Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obstetric Anesthesia Problems
- What is being tested?
- Peripheral perfusion index
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2022to 19 Mar 2023
- 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 to 50 years
- All sexes
- Adult
Study population: A total of 115 consecutive adult female patients, aged >18 years scheduled for the elective caesarian section under spinal anesthesia will be included in the study.
Who may be able to join
- ASA physical status 1-2 Age > 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia
Who cannot join
- pre-existing hypertension gestational hypertension or preeclampsia Diabetes mellitus, or autonomic neuropathy Patients with peripheral vascular diseases known fetal abnormality. Emergency caesarian section. Placenta previa or placenta accrete. absolute contraindications or failure to perform spinal anesthesia.Study
Trial locations and contacts
1 site in 1 country.
About this study
Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.
Read the detailed description
The perfusion index is the ratio of pulsatile blood flow to non-pulsatile in peripheral tissues and can be measured non-invasively using a pulse oximeter .Perfusion index measurement is considered a non-invasive rapid indicator of microcirculation variation and can help to detect circulation disturbance.It also can assess peripheral perfusion dynamics resulting from changes in peripheral vascular tone. Perfusion index changes according to posture with its highest value in Trendelenburg position and lowest value during 45-degree sitting position. However, to the best of our knowledge, no studies have studied the effect of posture on perfusion index in a full-term pregnancy, and its ability to predict hypotension following spinal anesthesia for elective cesarean delivery.
A previous study had found a correlation between baseline perfusion index and the incidence of post-spinal hypotension in the cesarean section, however, they haven't studied the effect of postural change on PI and its predictability of post-spinal induced hypotension(,Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.
- Conditions
- Obstetric Anesthesia Problems
- Being tested
- Peripheral perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral perfusion indexDevice
The study aimed to generate a model relating pre-spinal perfusion index to the likelihood and severity of the reduction in blood pressure in the first 20 min after spinal injection.
A correlation between the delta PI and the delta SBP (the difference between the baseline maternal systolic blood pressure and the lowest blood pressure)will be investigated to establish a predictive model to define cut-off values at which perfusion index variation indicated a low risk (no or mild hypotension groups) or a high risk (moderate, severe groups) of reduction in blood pressure.. The incremental change of a measure PI, the ΔPI will be calculated as the absolute change in PI between supine and sitting positions, ΔPI=PIsupine-sitting. The relative change in PI the rPI, will be expressed as the percentage of change in PI, rPI=ΔPI/PIsitting× 100.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of positional index in predicting post-spinal hypotension
The sensitivity of perfusion index postural change in predicting post-spinal anesthesia hypotension in caesarian section. surgeries.
Measured: 30 minutes post spinal anesthesia
Secondary outcomes (3)
The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
Measured: 30 minutes post spinal anesthesia
The sensitivity of supine perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
Measured: 30 minutes post spinal anesthesia
The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.
The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.
Measured: 30 minutes post spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start20 Mar 2022
- Primary completion18 Mar 2023
- Study completion19 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anesthesia ProblemsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdelghany ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269407
- Sponsor's protocol ID
- N120
- Status last verified
- Apr 2023
- First submitted
- 26 Feb 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section
- ClinicalTrials.gov ID
- NCT05269407
- Acronym / sponsor ID
- N120
- Conditions
- Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 19 Mar 2023 (actual)
- First posted
- 8 Mar 2022 (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.
Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.
Detailed description
The perfusion index is the ratio of pulsatile blood flow to non-pulsatile in peripheral tissues and can be measured non-invasively using a pulse oximeter .Perfusion index measurement is considered a non-invasive rapid indicator of microcirculation variation and can help to detect circulation disturbance.It also can assess peripheral perfusion dynamics resulting from changes in peripheral vascular tone. Perfusion index changes according to posture with its highest value in Trendelenburg position and lowest value during 45-degree sitting position. However, to the best of our knowledge, no studies have studied the effect of posture on perfusion index in a full-term pregnancy, and its ability to predict hypotension following spinal anesthesia for elective cesarean delivery.
A previous study had found a correlation between baseline perfusion index and the incidence of post-spinal hypotension in the cesarean section, however, they haven't studied the effect of postural change on PI and its predictability of post-spinal induced hypotension(,Our study aims to investigate the value of postural perfusion index changes as a non-invasive method to predict hypotension following spinal anesthesia for elective cesarean delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- A total of 115 consecutive adult female patients, aged >18 years scheduled for the elective caesarian section under spinal anesthesia will be included in the study.
Key inclusion criteria (1 listed)
- ASA physical status 1-2 Age > 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia
Key exclusion criteria (1 listed)
- pre-existing hypertension gestational hypertension or preeclampsia Diabetes mellitus, or autonomic neuropathy Patients with peripheral vascular diseases known fetal abnormality. Emergency caesarian section. Placenta previa or placenta accrete. absolute contraindications or failure to perform spinal anesthesia.Study
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 |
|---|---|---|
| Peripheral perfusion indexThe study aimed to generate a model relating pre-spinal perfusion index to the likelihood and severity of the reduction in blood pressure in the first 20 min after spinal injection. A correlation between the delta PI and the delta SBP (the difference between the baseline maternal systolic blood pressure and the lowest blood pressure)will be investigated to establish a predictive model to define cut-off values at which perfusion index variation indicated a low risk (no or mild hypotension groups) or a high risk (moderate, severe groups) of reduction in blood pressure.. The incremental change of a measure PI, the ΔPI will be calculated as the absolute change in PI between supine and sitting positions, ΔPI=PIsupine-sitting. The relative change in PI the rPI, will be expressed as the percentage of change in PI, rPI=ΔPI/PIsitting× 100. | Device | – |
Primary outcome
Sensitivity of positional index in predicting post-spinal hypotension
Time frame: 30 minutes post spinal anesthesia
The sensitivity of perfusion index postural change in predicting post-spinal anesthesia hypotension in caesarian section. surgeries.
3 secondary outcomes
The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
Time frame: 30 minutes post spinal anesthesia
The sensitivity of supine perfusion index to predict post-spinal anesthesia hypotension in caesarian section.
Time frame: 30 minutes post spinal anesthesia
The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.
Time frame: 30 minutes post spinal anesthesia
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 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Obstetric Anesthesia Problems
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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.
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 Obstetric Anesthesia Problems, run by Cairo University at 1 site in Egypt.
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 18 Apr 2023. 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 Egypt. 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?
Sensitivity of positional index in predicting post-spinal hypotension (time frame: 30 minutes post spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.