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NCT Number: NCT05269407

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

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.

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Key information

Conditions

Obstetric Anesthesia Problems

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Cairo, 11562, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral perfusion index

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.

  2. The sensitivity of supine perfusion index to predict post-spinal anesthesia hypotension in caesarian section.

    Time frame: 30 minutes post spinal anesthesia

    The sensitivity of sitting perfusion index to predict post-spinal anesthesia hypotension in caesarian section.

  3. 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

    The correlation between perfusion index postural change and the degree of severity of hypotension in caesarian section post spina anesthesia.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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