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

Recruiting

• Conditions: Shock
• Interventions: Other: Non-invasive blood pressure measurements

• Registration Number: NCT06460519
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-14
• Status Verified: 2024-10
• Study Start: 2024-10-03
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-11-03
• Study Completion: 2025-11-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intensive care unit patient with shock, who don't be in perioperative of cardiac surgery	Non-invasive blood pressure measurements	Patients of age superior or equal of 18 years, with a vasopressor support superior 0.5 µg/kg/min of equivalent norepinephrine during more than 30 minutes. The patients are not in perioperative of cardiac surgery (between the beginning of the intervention and 7 days after). The patients have a monitoring of arterial pressure with a radial arterial catheter, and the physician decided to have a monitoring of arterial pressure with a femoral arterial catheter.

Primary Outcome Measures

Name	Time	Method
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 primary outcome will be measure at the inclusion of the patient when the femoral arterial catheter will be in place.	The prevalence of the ATRAP will be show in percentage (%), with his confidence interval at 95%.

Trial Locations

Locations (5)

Département d'anesthésie Réanimation Hôpital Cardiologique Louis Pradel/Groupement Hospitalier Est; 🇫🇷 Bron, France

Hopital Edouard heriot/Groupement hospitalier Centre, service de médecine intensive réanimation; 🇫🇷 Lyon, France

Hôpital de la Croix-Rousse/Groupement hospitalier Nord, service d'anesthésie réanimation; 🇫🇷 Lyon, France

Centre hospitalier Lyon Sud/Groupement hospitalier Sud, Service d'anesthésie réanimation médecine intensive; 🇫🇷 Lyon, France

Hôpital Edouard Heriot/ Groupement hospitalier Centre, service d'anesthésie réanimation; 🇫🇷 Lyon, France