Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID06563544

Flow Versus Volume-Controlled Ventilation in Intubated Obstructive and Asthmatic Patients

Led by Erasmus Medical Center · Updated on 2024-10-18

10

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

M

Maasstad Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Flow-controlled ventilation (FCV) compared to Volume-controlled ventilation (VCV) in patients aged 18 years and older who are intubated due to an exacerbation of asthma or chronic obstructive pulmonary disease (COPD). This pilot study uses a randomized crossover design to test whether FCV can reduce the minute volume and dynamic hyperinflation in these patients, which may help decrease common complications associated with mechanical ventilation such as pneumothorax and cardiovascular collapse. Participants are mechanically ventilated using either FCV or VCV for two separate 90-minute periods, with patients randomized to begin with one mode before switching to the other. FCV delivers a low and constant flow during both inspiration and expiration, aiming to reduce airway resistance and prevent airway collapse, while VCV is set according to standard care. Measurements include flow, pressures, lung volumes, and gas exchange monitored by devices such as an electrical impedance tomography belt and an esophageal balloon. During the 180-minute study, patients receive continuous monitoring of ventilation parameters and hemodynamic status, with adjustments made to optimize compliance and carbon dioxide levels during FCV. Researchers assess the primary outcome of minute volume after 90 minutes on each ventilation mode and secondary outcomes including end-inspiratory lung volume and airway pressures. Because all patients are sedated and on mechanical ventilation, no additional discomfort is expected. The study includes safety monitoring to promptly manage any adverse events.

CONDITIONS

Brief Title

FCV Vs VCV in Obstructive and Asthmatic Patients

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 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 or less
Not Eligible

You will not qualify if you...

  • Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
  • Untreated pneumothorax (no pleural drainage)
  • Hemodynamic instability with mean arterial pressure below 60mmHg not responding to fluids or vasopressors or noradrenalin dose >0.5mcg/kg/min
  • High (>15 mmHg) or unstable intracranial pressure requiring sedation or osmotherapy
  • Inner tube diameter of 6mm or less
  • Anticipated withdrawal of life support or shift to palliative care
  • Inability to perform adequate electrical impedance tomography due to thorax size, wounds, bandages, deformities, recent lung surgery, ICD device, or subcutaneous emphysema
  • Contraindications for nasogastric tube or transpulmonary pressure measurements including recent esophageal surgery, prior esophagectomy, esophageal varices, or severe bleeding disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 hours

Participants receive two different ventilation modes, flow controlled ventilation (FCV) and volume controlled ventilation (VCV), each for 90 minutes in a randomized sequence. Measurements of lung volume and pressures are taken during these periods to compare ventilation effects.

1 continuous treatment period with monitoring

Trial Site Locations

Total: 2 locations

1

Erasmus Medical Center

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

2

Maasstad Hospital

Rotterdam, South Holland, Netherlands, 3079DZ

Actively Recruiting

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Research Team

J

Julien P Van Oosten, MD

A

Annemijn H Jonkman, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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