Shock SepticSHOCK PLETHNCT06786364
Types of Photoplethysmographic Waves in Adult Patients with Septic Shock
An observational study of Shock Septic and Photoplethysmography, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock Septic, Photoplethysmography, Waveform
- How many people
- 116 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2024to 30 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México Dr. Eduardo Liceaga
Mexico City, Cuauhtemoc, 06726
Hospital General de México Dr. Eduardo Liceaga Hospital General de México Dr. Eduardo Liceaga, Hospital, 5527892000 ext. 1316, direccionhgmliceaga@gmail.com
About this study
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.
Read the 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.
- Conditions
- Shock Septic, Photoplethysmography, Waveform
- Keywords
- shock septic, waveform, vasodilation, Photoplethysmography, arterial tone
- Medical subject headings
- Shock, Septic, Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After the inclusion of the patient.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: After the inclusion of the patien
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Nov 2024
- Primary completion1 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock SepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juan Fernando Bautista Garcia, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Juan Fernando Bautista Garcia, MD, Principal investigator, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786364
- Sponsor's protocol ID
- DI/24/401/03/33
- Acronym
- SHOCK PLETH
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30554338
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Types of Photoplethysmographic Waves in Adult Patients with Septic Shock
- ClinicalTrials.gov ID
- NCT06786364
- Acronym / sponsor ID
- SHOCK PLETH / DI/24/401/03/33
- Conditions
- Shock Septic, Photoplethysmography, Waveform
- Keywords
- shock septic, waveform, vasodilation, Photoplethysmography, arterial tone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 30554338Tusman 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.
- Individual participant dataSharing planned: No
Related trials for Shock Septic
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Fernando Bautista Garcia, MD principal investigator
Hospital General de México Dr. Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock Septic and Photoplethysmography, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Fernando Bautista Garcia, MD (5573855591, jbtagarcia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photoplethysmography wave types in adult patiens with septic shock (time frame: After the inclusion of the patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786364, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.