Types of Photoplethysmographic Waves in Adult Patients with Septic Shock

Recruiting

• Conditions: Shock Septic; Photoplethysmography; Waveform

• Registration Number: NCT06786364
• Lead Sponsor: Hospital General de México Dr. Eduardo Liceaga

Brief Summary

The objective of this study is to identify the types of Photoplethysmographic waves present in adults with septic shock and determine whether these waves correlate with other variables of tissue hypoperfusion such as capillary refil, serum lactate and mottling score.

Detailed Description

Photoplethysmography is the technology used in pulse oximeters in order to calculate arterial oxygen saturation and pulse rate, this technology generates a wave whose morphology has been related to blood flow and arterial tone. Recently Tusman and collaborators described a morphological classification of the photoplethysmografic wave that has a high correlation with arterial tone, such classification is divided in 6 types; Types I and II indicate vasoconstriction, Type III normal arterial tone and Types IV, V and VI describe mild, medium and severe vasodilation respectively, therefore it could be used to identify the arterial tone in those patients with septic shock. This study will identify the type of photoplethysmographic waves that are present in adults with septic shock based in the Tusman and collaborators classification, it will also describe the frequency of appearance and their correlation with other hemodynamic variables such as capillary refill, serum lactate, mottling score, heart rate, mean arterial pressure, pulse pressure and perfusion index.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Last Update Submitted: 2025-01-15
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Adult patients of 18 years of age and above dignossed with septic shock according to the definition stated in Sepsis 3.0
• Patients with axillary temperature above 36°C
• Patients and/or family that agree to participate in such study and sign the informed consentment
• Patients that tolerate supine position

Exclusion Criteria

• Patients with Cardiogenic shock, hipovolemic, obstructive and distributive (neurogenic, anafilactic) shock the exception being septic shock
• Patients with history of any type of cardiac arrhythmia
• Patients with history of chronic hepatic disease
• Patients with limited or diffuse systemic sclerosis
• Patients that have scarring, nail polish or thickened nails that may impede the proper placement and accurate measurement of photoplethysmography with the pulse oximeter
• Patients with history of heart insufficiency P- atients with septic shock that already have vasopressor aggents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Photoplethysmography wave types in adult patiens with septic shock	After the inclusion of the patient.	The type of Photoplethysmography wave obtained and digitized through the sensor of a conventional pulse oximeter without autoscale. The wave will be classified in type I, II, III, IV, V and VI according to the criteria proposed by Tusman and collaborators

Secondary Outcome Measures

Name	Time	Method
Capillary refill	After the inclusion of the patient	Mesurement of the time it takes for the ventral surface of the fingers to return to its normal color after being compressed by a transparent microscope slide for 10 seconds. Measured in seconds.
Mottling score	After the inclusion of the patient	Classification regarding the type of mottling surrounding the knee in each patient. The classification is as folllows 0= no mottling, 1= Mottling the size of a coin on the knee, 2= mottling extending just over the superior part of the knee, 3= Mottling covering up to half the thigh, 4= mottling continues to the inguinal fold, 5= severe mottling extending beyond the inguinal area.
Serum lactate levels	After the inclusion of the patient	Mesurement of serum lactate through venous blood gass analysis at hospital admittanace. Mesured in mmol/L
Heart rate	After the inclusion of the patient	Determination of the number of heart beats per minute in patients obtenined with telemetry. Messured in beats per minute
Sistolic and diastolic blood pressure	After the inclusion of the patient	Messurement of arterial blood pressure with an adult sized aneroid sphygmomanometer. Messurement in mmHg.
Perfussion index	After the inclusion of the patien	Messurement of the perfusion index obtained and calculated by a sensor in a conventional pulse oximeter without autoscale. Measurement in whole numbers.

Trial Locations

Locations (1)

Hospital General de México Dr. Eduardo Liceaga; 🇲🇽 Mexico city, Cuauhtemoc, Mexico