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Search / Trial NCT06140056

Two Modes of Mechanical Ventilation for Intensive Care Patients With Low Blood Oxygen Due to Breathing Difficulties

Launched by UNIVERSITY HOSPITAL BISPEBJERG AND FREDERIKSBERG · Nov 16, 2023

Trial Information

Current as of November 07, 2025

Recruiting

Keywords

Transpulmonary Pressure Airway Pressure Release Ventilation Volumen Controlled Mechanical Ventilation Esophageal Pressure Esophageal Manometry

ClinConnect Summary

This clinical trial is looking at how different methods of using mechanical ventilation can help patients in the intensive care unit (ICU) who are having trouble breathing and not getting enough oxygen. Specifically, it will compare two types of mechanical ventilation to see how each affects lung pressure. The goal is to improve the way we manage breathing difficulties in critically ill patients by understanding how these methods work.

To be eligible for this study, patients need to be admitted to the ICU and require mechanical ventilation with a certain level of oxygen support. This study is open to adults aged 18 and older. Participants can expect to receive one of the two ventilation methods while their lung pressure is closely monitored. It’s important to note that some patients may not qualify if they have specific lung conditions or other serious health issues. Overall, this study aims to enhance the care provided to patients facing serious breathing problems.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Admitted to the ICU
  • Invasive mechanical ventilation with FiO2 ≥ 50% OR PaO2-to-FiO2 ratio \<20 kPa, including PEEP 3 5 cmH20 for at least 6 hours
  • Exclusion Criteria:
  • Meeting inclusion criteria for more than 24 hours
  • Severe bronchospasm, defined as warranting treatment aimed at reversing this i.e. inhalation of anticholinergic or bronchodilator beyond what the patient normally use
  • Emphysema where treating physician judges the patient at increased risk for pneumothorax from APRV
  • Restrictive lung disease defined as a pre-admission diagnosis of restrictive lung disease
  • Undrained pneumothorax
  • Hemodynamic instability defined as more than 0.20 microgram/kg/min of norepinephrine or any dose of adrenaline infusion to maintain MAP ≥ 65 mmHg
  • Age \< 18 years
  • Patients who have received APRV previously during the current ICU admission
  • Patients in prone position within the last 24 hours

About University Hospital Bispebjerg And Frederiksberg

University Hospital Bispebjerg and Frederiksberg is a leading academic medical institution in Denmark, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital integrates cutting-edge scientific inquiry with patient-centered care, fostering collaboration among multidisciplinary teams of healthcare professionals and researchers. The institution emphasizes a strong commitment to ethical standards and regulatory compliance, ensuring that all trials are designed to enhance medical knowledge and improve patient outcomes. With a focus on a wide range of therapeutic areas, University Hospital Bispebjerg and Frederiksberg strives to contribute significantly to the global medical community and the advancement of evidence-based practice.

Locations

Hvidovre, Denmark

København, Denmark

Patients applied

0 patients applied

Trial Officials

Theis S Itenov, MD, PhD

Principal Investigator

University Hospital Bispebjerg and Frederiksberg

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported