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

NCT06140056 | Terminated

• 1 other identifier: H-23050947
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

The study examines individuals admitted to the intensive care unit due to breathing difficulties resulting in not getting enough oxygen into their bodies. These patient will receive mechanical ventilation and this study aims to determine how the pressure inside the lungs changes when using two different modes of mechanical ventilation. The goal is to improve management and care of breathing difficulties by gaining insight into changes in lung pressure during mechanical ventilation, as well as comparing the effectiveness of the two ventilator modes.

Conditions

Hypoxic Respiratory Failure; Ventilators, Mechanical

Keywords

Transpulmonary pressure; Airway pressure release ventilation; Volumen controlled mechanical ventilation; Esophageal pressure; Esophageal manometry

Outcome Measures

Primary Outcomes (1)

• Median peak transpulmonary pressure

  Measured with esophageal manometry in cmH20.

  During the observation period; 1-6 hours after randomization

Secondary Outcomes (9)

• Proportion of patients with peak transpulmonary pressure > 12 cmH2O

  During observation period; 1-6 hours after randomization

• Change in peak transpulmonary pressure in cmH20

  During observation period; 1-6 hours after randomization

• Fluctuations in transpulmonary pressure in cmH20

  During observation period; 1-6 hours after randomization

• Change in fluctuations of transpulmonary pressure in cmH20

  During observation period; 1-6 hours after randomization

• Nadir PaO2-to-FiO2 ratio

  During observation period; 1-6 hours after randomization

Other Outcomes (1)

• Proportion of patients unable to tolerate observation period without increasing ventilator settings

  During observation period; 1-6 hours after randomization

Study Arms (2)

Control

ACTIVE COMPARATOR

Duration: 3 hours

Other: Volumen controlled mechanical ventilation

Intervention

EXPERIMENTAL

Duration: 3 hours

Other: Airway pressure release ventilation

Interventions

Airway pressure release ventilation OTHER

Mechanical ventilation mode

Intervention

Volumen controlled mechanical ventilation OTHER

Mechanical ventilation mode

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (2)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Theis S Itenov, MD, PhD

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: November 18, 2023
• Study Start: December 8, 2023
• Primary Completion: August 3, 2025
• Study Completion: September 3, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: A year after publication of the primary outcome data
• Access Criteria: By written request to the steering committee. The sharing of data must be subject to a written agreement between the Capital Region of Denmark and receiver, and in accordance with data regulations. The steering committe will ensure that this.

Locations

DK (2)