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CompletedNCT05269407

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

Status
Completed
Phase
Study type
Observational
Enrollment
115 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers

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.

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

Interventions

TypeNameDescription
DEVICEPeripheral 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.

Timeline

Start date
2022-03-20
Primary completion
2023-03-18
Completion
2023-03-19
First posted
2022-03-08
Last updated
2023-04-18

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05269407. Inclusion in this directory is not an endorsement.

The Ability of the Change in Positional Perfusion Index in Predicting Post-spinal Anesthesia Hypotension in Caesarian Se (NCT05269407) · Clinical Trials Directory