NCT06563544

Brief Summary

The goal of this physiological pilot study with a randomized crossover design is to study the effect of Flow-controlled ventilation (FCV) on the minute volume compared to Volume-controlled ventilation (VCV) in intubated patients with an exacerbation of their asthma or COPD. Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category. Patients will be randomized between two ventilation sequences, namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Oct 2024Oct 2027

First Submitted

Initial submission to the registry

August 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

August 19, 2024

Last Update Submit

October 16, 2024

Conditions

Obstructive Pulmonary DiseaseMechanical Ventilation Pressure HighAsthma COPD

Outcome Measures

Primary Outcomes (1)

  • MV

    Minute Volume

    90 minutes

Secondary Outcomes (10)

  • EILV

    90 minutes

  • Vei

    90 minutes

  • MP

    90 minutes

  • Dissipated energy

    30 and 90 minutes

  • Airway pressures

    30 and 90 minutes

  • +5 more secondary outcomes

Study Arms (2)

FCV-VCV

EXPERIMENTAL

90 minutes of FCV followed by 90 minutes of VCV

Device: FCV

VCV-FCV

EXPERIMENTAL

90 minutes of VCV followed by 90 minutes of FCV

Device: FCV

Interventions

FCVDEVICE

90 minutes of FCV

Also known as: Flow-controlled ventilation
FCV-VCVVCV-FCV

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older;
  • Provided written informed consent;
  • Undergoing controlled mechanical ventilation via an endotracheal tube;
  • Reason for intubation being exacerbation of asthma or COPD;
  • Intubated ≤72 hours

You may not qualify if:

  • Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
  • Untreated pneumothorax (i.e. no pleural drainage)
  • Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose \>0.5mcrg/kg/min
  • High (\>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
  • An inner tube diameter of 6mm or less
  • Anticipating withdrawal of life support and/or shift to palliation as the goal of care
  • Inability to perform adequate electrical impedance tomography (EIT) measurements with, e.g.:
  • Have a thorax circumference inappropriate for EIT-belt
  • Thoracic wounds, bandages or deformities preventing adequate fit of EIT-belt
  • Recent (\<7 days) pulmonary surgery including pneumonectomy, lobectomy or lung transplantation
  • ICD device present (potential interference with proper functioning of the EIT device and ICD device)
  • Excessive subcutaneous emphysema
  • Contra-indications for nasogastric tube or inability to perform adequate transpulmonary pressure measurements with, e.g.:
  • Recent esophageal surgery
  • Prior esophagectomy
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Diederik P Gommers, Prof. Dr.

    Erasmus Medical Center

    STUDY DIRECTOR

Central Study Contacts

Julien P Van Oosten, MD

CONTACT

+31630600232j.vanoosten@erasmusmc.nl

Annemijn H Jonkman, Dr.

CONTACT

+31627858466a.jonkman@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Physiological pilot study with a randomized crossover design comparing FCV and VCV
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. A.H. Jonkman

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 21, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

After the study is completed the researchers will deliver the study data to other researchers if asked for with good argumentation

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After study completion
Access Criteria
Against good argumentation on request

Locations

NL(2)