Early Switch from Controlled to Assisted Ventilation

NCT06438198 | Recruiting

• 1 other identifier: MEC-2024-0011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this physiological intervention study is to unravel the (patho)physiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure (PaO2/FiO2 ratio \< 200 mmHg). The intervention is that participants will be switched from controlled to assisted ventilation when PaO2/FiO2 ratio \> 200 mmHg. The primary endpoint is the change in regional lung stress (as derived by electrical impedance tomography) when switching from controlled to assisted ventilation and until a successful or failed switch.

Conditions

Acute Hypoxemic Respiratory Failure; Mechanical Ventilation

Keywords

Electrical Impedance Tomography; Esophageal manometry; Controlled Mechanical Ventilation; Assisted Mechanical Ventilation; Respiratory Monitoring

Outcome Measures

Primary Outcomes (1)

• Regional lung stress

  The change in regional lung stress as derived from EIT recordings by computing the regional ventilation distribution (ventral-to-dorsal ratio).

  72 hours

Secondary Outcomes (11)

• Electrical Impedance Tomography (EIT) parameters

  72 hours

• Photon-Counting Computed Tomography (PCCT)-derived ventilation/perfusion mismatch

  30 minutes

• Electrical Impedance Tomography (EIT)-derived ventilation/perfusion mismatch

  30 minutes

• Respiratory mechanics

  72 hours

• Breathing effort

  72 hours

Study Arms (1)

Mechanically ventilated adults

EXPERIMENTAL

Switch from controlled to assisted mechanical ventilation when PaO2/FiO2-ratio \> 200 mmHg. Before switch (on controlled ventilation) participants will undergo an electrical impedance tomography (EIT) perfusion measurement as well as a photon-counting CT (PCCT) scan to assess lung perfusion and ventilation/perfusion mismatch. From 15 minutes before until 4 hours after switch and 30 minutes twice daily for 72 hours or until switch failure participants will be monitored continuously using EIT, esophageal pressure and gastric pressure.

Other: Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg

Interventions

Pre-specified switch from controlled to assisted ventilation when PaO2/FiO2-ratio > 200 mmHg OTHER

A pre-specified switch from controlled to assisted ventilation will be initiated when PaO2/FiO2-ratio \> 200 mmHg. The moment of switch is pre-specified but patient management and ventilator settings are up to the clinical team. Switch is complete when the patient triggers all breaths spontaneously. Switch success is defined if patient reaches 72 hours on assisted ventilation. Switch failure is defined if patient switches back to controlled ventilation for more than 2 hours before 72 hours.

Mechanically ventilated adults

Eligibility Criteria

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

You may qualify if:

• years old
• Written informed consent from a legal representative
• Mechanical ventilation via an endotracheal tube
• Acute hypoxemic respiratory failure with PaO2/FiO2 ratio \< 200 mmHg
• Under continuous sedation with or without paralysis

You may not qualify if:

• Expected mechanical ventilation duration of \<48 hours
• Pure chronic obstructive pulmonary disease exacerbation
• Pre-existent respiratory muscle disease
• Contraindication to EIT monitoring (as per clinical protocol, e.g. pacemaker, burns or thoracic wounds limiting electrode placement)
• Contra-indications to oesophageal manometry (as per clinical protocol, e.g., recent oesophageal surgery, oesophageal varices, severe bleeding disorders)
• Known pregnancy
• Anticipating withdrawal of life support and/or shift to palliation as the goal of care

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Annemijn Jonkman, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemijn Jonkman, PhD

CONTACT

+3110-7035142; a.jonkman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 31, 2024
• Study Start: September 15, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)