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Recruiting NCT06786364

Types of Photoplethysmographic Waves in Adult Patients with Septic Shock

— Observational Shock Septic Photoplethysmography Waveform

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Shock Septic, Photoplethysmography, Waveform. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • Photoplethysmography wave types in adult patiens with septic shock [Time frame: After the inclusion of the patient.]
Secondary outcome measures (6)
  • Capillary refill [Time frame: After the inclusion of the patient]
  • Mottling score [Time frame: After the inclusion of the patient]
  • Serum lactate levels [Time frame: After the inclusion of the patient]
  • Heart rate [Time frame: After the inclusion of the patient]
  • Sistolic and diastolic blood pressure [Time frame: After the inclusion of the patient]
  • Perfussion index [Time frame: After the inclusion of the patien]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Mexico · 1 center
  • Hospital General de México Dr. Eduardo Liceaga — Mexico City

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. PMID 30554338

Identifiers

NCT: NCT06786364 · DI/24/401/03/33

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗