Types of Photoplethysmographic Waves in Adult Patients with Septic Shock

NCT06786364 | Recruiting DMC

• 1 other identifier: DI/24/401/03/33
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock Septic; Photoplethysmography; Waveform

Keywords

shock septic; waveform; vasodilation; Photoplethysmography; arterial tone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Capillary refill

  After the inclusion of the patient

• Mottling score

  After the inclusion of the patient

• Serum lactate levels

  After the inclusion of the patient

• Heart rate

  After the inclusion of the patient

• Sistolic and diastolic blood pressure

  After the inclusion of the patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead

Study Sites (1)

Hospital General de México Dr. Eduardo Liceaga

Mexico City, Cuauhtemoc, 06726, Mexico

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Aneurysm

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juan Fernando Bautista Garcia, MD

  Hospital General de México Dr. Eduardo Liceaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Fernando Bautista Garcia, MD

CONTACT

5573855591; jbtagarcia@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 30, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)