The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section

Obstetric Anesthesia Problems Clinical Trial

Official title:

The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269407
• Other study ID #: N120
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hypotension
• Obstetric Anesthesia Problems

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