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Flow Controlled Ventilation (FCV) With the Evone Ventilator and Tritube Versus Volume Controlled Ventilation (VCV)

NCT03873233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-09-06

No results posted yet for this study

Summary

The Evone® ventilator is a new device capable of lung ventilation through a narrow-bore cannula, the Tritube.Two ventilation modes are possible: high frequency jet ventilation (HFJV) and flow-controlled ventilation (FCV). In this prospective pilot study the efficacy of FCV using the Evone® ventilator and Tritube is investigated when compared with Volume Controlled Ventilation (VCV) via a normal tracheal tube.

Conditions

  • Pulmonary Ventilation

Interventions

DEVICE

Aisys Carestation ventilator and normal endotracheal tube

Fraction of Inspired Oxygen (FIO2) 0.3 End Expiratory Pressure (EEP) at +5 cm H2O Ratio of duration of inspiration to the duration of expiration (I:E ratio) 1:1 Tidal Volume: 6 mL/kg Zero inspiratory pause Respiratory frequency will be adapted to produce an End-Tidal CO2 35-40 mmHg

DEVICE

Evone ventilator and Tritube

Fraction of Inspired Oxygen (FIO2) 0.3 Ratio of duration of inspiration to the duration of expiration (I:E ratio) 1:1 End Expiratory Pressure (EEP) at +5 cm H2O Flow: start with 10 L/min and adjusted along with the peak inspiratory pressure to produce a tidal volume of 6 mL/kg and End-Tidal CO2 35-40 mmHg

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Vera Saldien, MD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2019-08-05
Completion
2019-08-05

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873233 on ClinicalTrials.gov