Types of Photoplethysmographic Waves in Adult Patients with Septic Shock (SHOCK PLETH)

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.

Study Overview

• Status: Recruiting
• Conditions: Photoplethysmography; Shock Septic; Waveform

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 Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

• Study Contact: Name: Juan Fernando Bautista Garcia, MD; Phone Number: 5573855591; Email: jbtagarcia@gmail.com

Study Locations

• Mexico
  • Cuauhtemoc
    • Mexico city, Cuauhtemoc, Mexico, 06726
      • Recruiting
      • Hospital General de México Dr. Eduardo Liceaga
      • Contact: Hospital General de México Dr. Eduardo Liceaga Hospital General de México Dr. Eduardo Liceaga, Hospital; Phone Number: 1316 5527892000; Email: direccionhgmliceaga@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to the emergency department at "Hospital General de México Dr. Eduardo Liceaga" and meet the criteria for septic shock established in Sepsis 3.0 and have signed the informed consentment will be included in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Photoplethysmography wave types in adult patiens with septic shock	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	After the inclusion of the patient.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary refill	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.	After the inclusion of the patient
Mottling score	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.	After the inclusion of the patient
Serum lactate levels	Mesurement of serum lactate through venous blood gass analysis at hospital admittanace. Mesured in mmol/L	After the inclusion of the patient
Heart rate	Determination of the number of heart beats per minute in patients obtenined with telemetry. Messured in beats per minute	After the inclusion of the patient
Sistolic and diastolic blood pressure	Messurement of arterial blood pressure with an adult sized aneroid sphygmomanometer. Messurement in mmHg.	After the inclusion of the patient
Perfussion index	Messurement of the perfusion index obtained and calculated by a sensor in a conventional pulse oximeter without autoscale. Measurement in whole numbers.	After the inclusion of the patien

Collaborators and Investigators

• Sponsor: Hospital General de México Dr. Eduardo Liceaga
• Investigators: Principal Investigator: Juan Fernando Bautista Garcia, MD, Hospital General de México Dr. Eduardo Liceaga

Publications and helpful links

General Publications

• Tusman G, Acosta CM, Pulletz S, Bohm SH, Scandurra A, Arca JM, Madorno M, Sipmann FS. Photoplethysmographic characterization of vascular tone mediated changes in arterial pressure: an observational study. J Clin Monit Comput. 2019 Oct;33(5):815-824. doi: 10.1007/s10877-018-0235-z. Epub 2018 Dec 15.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Photoplethysmography; vasodilation; shock septic; waveform; arterial tone
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Shock, Septic
• Other Study ID Numbers: DI/24/401/03/33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No