Ventilator Study in the NICU

Summary

Background:

Optimal adjustment of mechanical ventilation in intensive care patients is crucial to ensure effective ventilation and to reduce the risk of ventilator-associated complications such as pneumonia and ventilator-induced lung injury. Current monitoring methods may often be insufficient to achieve truly optimal ventilator settings in routine clinical practice. By applying a specific breathing pattern, additional key ventilation-related parameters can be monitored and adjusted using a novel carbon dioxide-based method. This approach has the potential to substantially improve ventilation in critically ill patients.

The carbon dioxide-based method utilizes a modified intensive care ventilator (Servo-i®, Getinge) equipped with CE-marked research software. The software modifies the breathing pattern by introducing three slightly prolonged expiratory pauses in three out of nine breaths. This ventilator has been used in multiple large-animal studies and clinical trials, including two conducted by the present research group.

Study Design:

The study will include adult patients receiving mechanical ventilation in a neurointensive care unit due to brain injury. Patients must be in a stable phase with regard to neurological status and circulation and require controlled mechanical ventilation. Informed consent will be obtained from the patient after recovery when applicable.

Part 1 (Pilot Study):

This is an observational study including 15 patients, aiming to establish reference values for parameters obtained using the carbon dioxide-based method, such as end-expiratory lung volume and mixed venous oxygen saturation. Patients will be switched to the research ventilator for 15-20 minutes, during which measurements from the carbon dioxide-based method and standard vital sign monitoring will be collected. Ventilator settings will be identical to those used on the patient's conventional ventilator. After completion of the protocol, patients will be switched back to their standard ventilator.

Part 2 (Main Study):

This is an interventional study with a within-subject (self-controlled) design, including 15 mechanically ventilated patients with stable brain injury. The aim is to optimize ventilator settings using the carbon dioxide-based method to achieve more lung-protective ventilation.

Patients will be transferred to the research ventilator using the same procedure as in the pilot study, initially maintaining the same ventilator settings. After a 10-minute stabilization period, ventilatory parameters will be recorded and an arterial blood gas sample obtained (baseline). The specific breathing pattern will then be initiated, and ventilation will be adjusted based on additional parameters provided by the capnodynamic method (end-expiratory lung volume, cardiac output, and mixed venous oxygen saturation). Measurements and arterial blood gases will be repeated immediately after initiation of the breathing pattern and again 15 minutes after ventilator adjustments. The study will then conclude, and the patient will be returned to their standard ventilator using the optimized ventilator settings to potentially ensure patient benefit.

Conditions

• Neuro-intensive Care Unit Patients

Interventions

DEVICE

Capnodynamic method

Applying the capnodynamic method using a modified intensive care ventilator and subsequently use additional parameters like effective lung volume (ELV) in order to adjust ventilator settings to minimize driving pressure.

Sponsors & Collaborators

• Håkan Björne

  lead OTHER_GOV

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-06-30

Completion

2027-08-31

Countries

• Sweden

Study Locations