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Search / Trial NCT06448988

Evaluation of Respiratory Mechanics in Supine and PARK-bench Positions (SPARK)

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jun 3, 2024

Trial Information

Current as of November 07, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This is a prospective, observational study called SPARK. Researchers want to understand how moving from lying on the back (supine) to a Park-Bench position during brain surgery changes where air goes inside the lungs (which parts fill with air) and how often the airways may close during the procedure. The goal is to learn about breathing mechanics during surgery so doctors can adjust ventilation to protect the lungs and avoid ventilator-related lung injury.

Who can participate? Adults 18 years and older who are scheduled for elective neurosurgery in the Park-Bench position at Fondazione Policlinico Gemelli in Rome, Italy. The study plans to enroll about 22 participants. Key inclusions: age over 18 and planned Park-Bench neurosurgery. Exclusions include BMI over 30, existing significant lung disease requiring oxygen, pregnancy, pacemaker, certain chest/heart conditions, recent chest surgery or lung metastases, and unstable blood pressure. Participation involves observational measurements during the operation to compare lung volume distribution between positions; there is no experimental treatment, and personal data are not shared beyond the study. The study is currently enrolling, with expected completion around mid-2025.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age \>18
  • Patients scheduled for elective neurosurgery in Park-Bench position.
  • Exclusion Criteria:
  • Age \< 18
  • BMI \> 30 kg/m2
  • Obstructive or restrictive lung disease with oxygen supplementation
  • Pacemaker
  • Pregnancy
  • Absence of history of pulmonary embolism, thoracic surgery or chest wall abnormalities, organ transplant, lung metastases
  • New York Heart Association \>2 or hemodynamic instability (Mean Arterial Pressure\<60mHg)

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Rome, Italy

Patients applied

0 patients applied

Trial Officials

Giuliano Ferrone, MD

Principal Investigator

Fondazione Policlinico Gemelli, Rome

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported