Clinical trial NCT06786364: Types of Photoplethysmographic Waves in Adult Patients with Septic Shock
Official title: Types of Photoplethysmographic Waves in Adult Patients with Septic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shock Septic
Photoplethysmography
Waveform
Keywords: shock septic
waveform
vasodilation
Photoplethysmography
arterial tone
Lead sponsor: Hospital General de México Dr. Eduardo Liceaga
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Photoplethysmography wave types in adult patiens with septic shock
timeFrame: After the inclusion of the patient.
Secondary outcomes:
measure: Capillary refill
timeFrame: After the inclusion of the patient
measure: Mottling score
timeFrame: After the inclusion of the patient
measure: Serum lactate levels
timeFrame: After the inclusion of the patient
measure: Heart rate
timeFrame: After the inclusion of the patient
measure: Sistolic and diastolic blood pressure
timeFrame: After the inclusion of the patient
measure: Perfussion index
timeFrame: After the inclusion of the patien
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Hospital General de México Dr. Eduardo Liceaga
state: Cuauhtemoc
Study officials:
affiliation: Hospital General de México Dr. Eduardo Liceaga
name: Juan Fernando Bautista Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.