Changes in Pulse-Oximetry Perfusion Index Induced by Tidal Volume Challenge Versus Fluid Volume Challenge to Detect Preload Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume
Launched by BENHA UNIVERSITY · Nov 2, 2024
Trial Information
Current as of November 12, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a prospective, observational study happening at Benha University in Egypt. Researchers will enroll about 75 adults who are on invasive mechanical ventilation and have circulatory problems. They want to see if a noninvasive measurement called the perfusion index (PI), taken from a pulse oximeter, can help identify preload responsiveness—meaning whether the heart’s output might improve if the patient’s fluid status is tested. To do this, doctors will use two tests (a tidal volume challenge and a fluid challenge) to see how PI and another ultrasound measure (VTI) change. The study will mainly compare these changes to understand which signal best indicates the heart’s response to fluid or breathing-support changes.
Who can join? Adults 18 and older, in sinus rhythm, who are on a ventilator with a tidal volume around 6 mL/kg of predicted body weight, and for whom the clinicians are planning tests to assess preload responsiveness. Exclusions include open chest, certain lung or heart conditions, pregnancy, obesity, abdominal pressure, prone positioning, or atrial fibrillation. This is not a drug or device trial, results aren’t available yet, and the study is expected to wrap up around February 28, 2025.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients of both genders aged 18 years or older Invasive mechanical ventilation in assist controlled mode with a Vt of 6 mL/kg PBW, Patients with circulatory failure Decision by the clinicians in charge to assess preload responsiveness through a Vt Challenge and a Fluid Challenge test.
- • Patients in sinus rhythm
- Exclusion Criteria:
- • Open chest Pulmonary hypertension Poor lung compliance (Crs \<30 ml/cmH2O) Obesity (BMI≥35) Pregnancy Intraabdominal hypertension Prone position Atrial fibrillation
About Benha University
Benha University, a leading institution in Egypt, is dedicated to advancing medical research and innovation through rigorous clinical trials. With a strong emphasis on multidisciplinary collaboration, the university aims to enhance healthcare outcomes by exploring novel therapeutic approaches and interventions. Its state-of-the-art facilities and commitment to ethical research practices ensure that all trials are conducted with the highest standards of integrity and scientific rigor. Benha University actively contributes to the global medical community by fostering partnerships and disseminating findings that can improve patient care and inform public health policies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Banhā, Al Qalyubia, Egypt
Patients applied
Trial Officials
Ahmed Mostafa Abdelhamid
Principal Investigator
Benha University
Samar Rafik Mohamed Amin
Principal Investigator
Benha University
Mona Sobhy Emara
Principal Investigator
Benha University
Salwa Abbas Awad Eltahawy
Principal Investigator
Benha University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported