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Search / Trial NCT06673862

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

Fluid Responsiveness Vti Pi Tidal Volume Challenge Fluid Challenge Perfusion Index Velocity Time Index Preload Responsiveness

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.

Locations

Banhā, Al Qalyubia, Egypt

Patients applied

0 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