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

Shock Clinical Trial

— PARECHOC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460519
• Other study ID #: 69HCL24_0264
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Hospices Civils de Lyon
• Contact: Matthias Jacquet-lagreze, Dr
• Phone: 0783426888
• Email: matthias.jacquet-lagreze[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

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)

Locations

Country	Name	City	State
France	Département d'anesthésie Réanimation Hôpital Cardiologique Louis Pradel/Groupement Hospitalier Est	Bron
France	Centre hospitalier Lyon Sud/Groupement hospitalier Sud, Service d'anesthésie réanimation médecine intensive	Lyon
France	Hôpital de la Croix-Rousse/Groupement hospitalier Nord, service d'anesthésie réanimation	Lyon
France	Hôpital Edouard Heriot/ Groupement hospitalier Centre, service d'anesthésie réanimation	Lyon
France	Hopital Edouard heriot/Groupement hospitalier Centre, service de médecine intensive réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The prevalence of the ATRAP will be show in percentage (%), with his confidence interval at 95%.	The primary outcome will be measure at the inclusion of the patient when the femoral arterial catheter will be in place.