Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250374
Other study ID # 2023-A00270-45
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 24, 2023
Est. completion date May 24, 2025

Study information

Verified date August 2023
Source Fondation Hôpital Saint-Joseph
Contact Sylvain DIOP, Dr
Phone +33140948637
Email sdiop@ghpsj.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cardiopulmonary bypass (CPB) surgery present risk of acute postoperative neurological complications. These complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. The causes are usually multifactorial, but altered cerebral perfusion during CPB surgery is an important prognostic factor. Data regarding the effect of deep hypothermia on cerebral perfusion during CPB in adult are scarce. Currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (PAE) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia. In this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries. To protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°C. Deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. It also increases the solubility of CO2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions. In adult there is no consistent data on the cerebral perfusion during PAE surgery under deep hypothermia at 18-20°C. Animal studies showed that cerebral regulation seems to be preserved under these conditions. A better understanding of the effect of deep hypothermia on cerebral perfusion during PAE surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date May 24, 2025
Est. primary completion date February 24, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled for pulmonary artery thromboendarterectomy surgery. - Patient with free, written and informed consent. - Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary). - French-speaking patient. Exclusion Criteria: - Patient refusing to participate in the study. - Patient under guardianship. - Patient deprived of liberty. - Pregnant or breast-feeding women.

Study Design


Intervention

Procedure:
Bilateral trans-cranial Doppler ultrasound
Velocity measurements in the middle cerebral artery are made using an ultrasound probe applied to the patient's temple during surgery.

Locations

Country Name City State
France Hôpital Marie Lannelongue Le Plessis-Robinson

Sponsors (1)

Lead Sponsor Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

References & Publications (2)

Brown CH 4th, Neufeld KJ, Tian J, Probert J, LaFlam A, Max L, Hori D, Nomura Y, Mandal K, Brady K, Hogue CW; Cerebral Autoregulation Study Group; Shah A, Zehr K, Cameron D, Conte J, Bienvenu OJ, Gottesman R, Yamaguchi A, Kraut M. Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial. JAMA Surg. 2019 Sep 1;154(9):819-826. doi: 10.1001/jamasurg.2019.1163. — View Citation

Liu Y, Chen K, Mei W. Neurological complications after cardiac surgery: anesthetic considerations based on outcome evidence. Curr Opin Anaesthesiol. 2019 Oct;32(5):563-567. doi: 10.1097/ACO.0000000000000755. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of cerebral blood perfusion during deep hypothermia Cerebral blood perfusion during deep hypothermia (18-20°C) will be assessed by measuring mean blood flow velocities in the middle cerebral arteries (MCAs) using trans-cranial Doppler ultrasound (DTC) at different time of the surgery (Four measures in total). All measure are performed during the time of the surgery. The first measure (M1) is baseline to which the other measure will be compared to. M1: Baseline-normothermia after induction of general anesthesia (H0) M2: During CPB-at 18°C-before cardiac arrest (H2) M3: After cardiac arrest-at 18°C before (H4) M4: End of surgery-normothermia (H6)
Secondary Correlation between NIRS and middle cerebral arteries velocity values for each measure. For each measure of middle cerebral arteries blood flow velocity performed during the surgery, the value of the near infrared spectroscopy (NIRS) is recorded. A total of four measures is performed during the time of the surgery. M1: Baseline-normothermia after induction of general anesthesia (H0) M2: During CPB-at 18°C-before cardiac arrest (H2) M3: After cardiac arrest-at 18°C before (H4) M4: End of surgery-normothermia (H6)
Secondary Seek for post-circulatory arrest hyperemia Comparison of the middle cerebral arteries blood flow velocities during the period of hypothermia, before and after cardiac arrest. M2: During CPB after cooling at 18°C before cardiac arrest (H2). M3: After cardiac arrest at 18°C before rewarming period (H4).
See also
  Status Clinical Trial Phase
Withdrawn NCT01950585 - Hydroxyurea in Pulmonary Arterial Hypertension Early Phase 1
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT01894035 - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting NCT04083729 - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy N/A
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Completed NCT02821156 - Study on the Use of Inhaled NO (iNO) N/A
Completed NCT02216279 - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension Phase 2
Recruiting NCT01913847 - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT06240871 - Contrast Enhanced PA Pressure Measurements
Completed NCT02377934 - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Recruiting NCT01091012 - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension Phase 3
Completed NCT02275793 - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Completed NCT01463514 - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension N/A
Completed NCT00739375 - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension. Phase 1
Completed NCT01484899 - Smoking: a Risk Factor for Pulmonary Arterial Hypertension? N/A