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NCT Number: NCT06786364

Types of Photoplethysmographic Waves in Adult Patients with Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de México Dr. Eduardo Liceaga

Mexico City, Cuauhtemoc, 06726, Mexico

Location status: Recruiting

Location contact

Hospital General de México Dr. Eduardo Liceaga Hospital General de México Dr. Eduardo Liceaga, Hospital

CONTACT

[email protected]

5527892000 ext. 1316

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Photoplethysmography wave types in adult patiens with septic shock

    Time frame: 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 outcomes

  1. Capillary refill

    Time frame: 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.

  2. Mottling score

    Time frame: 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.

  3. Serum lactate levels

    Time frame: After the inclusion of the patient

    Mesurement of serum lactate through venous blood gass analysis at hospital admittanace. Mesured in mmol/L

  4. Heart rate

    Time frame: 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

  5. Sistolic and diastolic blood pressure

    Time frame: After the inclusion of the patient

    Messurement of arterial blood pressure with an adult sized aneroid sphygmomanometer. Messurement in mmHg.

  6. Perfussion index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Fernando Bautista Garcia, MD

CONTACT

[email protected]

5573855591

Sponsors and collaborators

Lead sponsor

Hospital General de México Dr. Eduardo Liceaga

Other Gov

Registry information

Acronym: SHOCK PLETH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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