Ventilator Study in the NICU

May 8, 2026 updated by: Håkan Björne

Titration of End-expiratory Lung Volume Using the Capnodynamic Method in Intubated Neurointensive Care Patients - Effects on Driving Pressure, Compliance, and Mixed Venous Oxygen Saturation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary outcome measure is a reduction in driving pressure, as it is well established that a driving pressure >15 cmH₂O is associated with an increased risk of lung injury (ventilator-induced lung injury, VILI). Clinical observations in the intended study population show driving pressures of approximately 19 cmH₂O with an estimated standard deviation of 2 cmH₂O (study baseline). When these values are entered into a power calculation for a paired two-sided t-test, a sample size of approximately 10 patients is obtained. To account for potential dropouts, the study group size is set at 15 patients. The significance level is <0.05, with a power of 80%.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stable with regard to intracranial pressure
  • Hemodynamically stable

Exclusion Criteria:

  • Ongoing instability with regard to intracranial pressure and circulation
  • Spontaneous breathing / patient-triggered ventilation
  • If the patient subsequently declines consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single group vetilation arm, both for pilot and main study
Intervention i main study will be adjusting ventilator settings using capnodynamic parameters to minimize driving pressure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Driving pressure (deltaP) cmH2O.
Time Frame: Study protocols will have a time frame och 15-30 minutes.
Difference in driving pressure (dP) before and after ventilatory adjustments.
Study protocols will have a time frame och 15-30 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ELV (ml)
Time Frame: 15-30 minutes
Normal values of effective lung volume (ELV) with patients int 30 degrees head up position.
15-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Håkan Björne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIV-ID CIV-26-01-055996
  • 2026-01383-01 (Other Identifier: Swedish Ethical Review Authority)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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