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Recruiting NCT06460519

The Prevalence of the Aortic to Radial Pressure Gradient in States of Shock, Outside the Context of Cardiac Surgery, a Prospective Study

Observational Shock

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
The protocol lists: Non-invasive blood pressure measurements.
Who it may be relevant to
Registry conditions: Shock. Basic parameters: 18 years — 99 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
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prevalence of the Aortic to Radial Pressure Gradient in States of Shock

Overview

First described in cardiac surgery, the aortic to radial pressure gradient (ATRAP) is the cause of an underestimation of the aortic pressure with a measure assumed with a radial catheter, and he can concert 1 of 3rd patients. The risks factor well known are small height, previous hypertension, long and difficult surgery, radial artery diameter less than 1.8mm. The ATRAP definition is a pressure difference between radial and femoral (same of the aortic pressure) pressure of 25mmHg on the systolic pressure, or a pressure difference on the mean pressure of 10mmHg, both measures realised by arterial canulation, and with a duration superior than 5 minutes. If this gradient appears in pathophysiological specifics situations, there is a risk of inappropriate administration of vasopressors, with more hospitalisation days, more side effect of vasopressors like an augmentation of myocardial work. The ATRAP is documented in septic shock with a prevalence between 21% and 27%. The ATRAP can appear in shocks, moreover with doses of equivalent norepinephrine of 0.5 µg/kg/min who is use for the definition of refractive shock, the difference between the two pressure is higher if the dose of equivalent norepinephrine is higher than 1µg/kg/min. But the prevalence and risks factors are barely unknowns in this situation. Most of the time, a radial arterial catheter is used for hemodynamic monitoring for his simplicity of utilisation and the lows complications associated. Some medical teams in cardiac surgeries, or in intensive care unit (ICU) for the management of shocks used often radial and femoral arterial catheter. It seems there is no at risk for the utilisation of a radial and femoral arterial canulation. Out of the situation of cardiac surgery, there is a lack of information of the ATRAP, the objective of the study is to evaluate the prevalence of the ATRAP in shock, out of the situation of cardiac surgery.

Interventions

  • Other Non-invasive blood pressure measurements
    Non-invasive blood pressure measurements to the tension cuff three times in a row on each side (right arm and left arm)

Primary outcome measures

  • Prevalence (percentage) of ATRAP is determined by the ratio of patients with ATRAP to total. ATRAP is defined by a 25mmHg systolic or 10mmHg mean pressure difference between radial and femoral arterial pressures during more than 5 minutes. [Time frame: The primary outcome will be measure at the inclusion of the patient when the femoral arterial catheter will be in place.]

Eligibility criteria

Inclusion criteria

  • age superior or equal 18 years
  • Vasopressors support superior or equal 0.5 µg/kg/min of equivalent norepinephrine
  • Invasive monitoring of blood pressure with a radial arterial catheter and a femoral arterial catheter decided by de physician
  • Beginning of the shock less than 48 hours.
  • Consent

Exclusion criteria

  • perioperative of cardiac surgery (between the beginning of the surgery and 7 days after)
  • pregnant woman or breast-feeding
  • Major person under protection
  • Person with privation of liberty by a justice decision, or an administrative decision

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
Cohort

Study locations

France · 6 centers
  • Département d'anesthésie Réanimation Hôpital Cardiologique Louis Pradel/Groupement Hospita — Bron
  • Hopital Edouard heriot/Groupement hospitalier Centre, service de médecine intensive réanim — Lyon
  • Hôpital Edouard Heriot/ Groupement hospitalier Centre, service d'anesthésie réanimation — Lyon
  • Hôpital de la Croix-Rousse/Groupement hospitalier Nord, service d'anesthésie réanimation — Lyon
  • Hôpital Saint Joseph Saint Luc — Lyon
  • Centre hospitalier Lyon Sud/Groupement hospitalier Sud, Service d'anesthésie réanimation m — Lyon

Identifiers

NCT: NCT06460519 · 69HCL24_0264

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗