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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269407
Other study ID # N120
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2022
Est. completion date March 19, 2023

Study information

Verified date April 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date March 19, 2023
Est. primary completion date March 18, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - ASA physical status 1-2 Age > 18 years uncomplicated singleton pregnancy at full-term Elective scheduled caesarian section under spinal anesthesia Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Peripheral perfusion index
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 ?PI will be calculated as the absolute change in PI between supine and sitting positions, ?PI=PIsupine-sitting. The relative change in PI the rPI, will be expressed as the percentage of change in PI, rPI=?PI/PIsitting× 100.

Locations

Country Name City State
Egypt Faculty of Medicine Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 minutes post spinal anesthesia
Secondary 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. 30 minutes post spinal anesthesia
Secondary 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. 30 minutes post spinal anesthesia
Secondary 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. 30 minutes post spinal anesthesia
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