Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873233
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Joke De Wachter, University Hospital, Antwerp

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Ventilation Device: Aisys Carestation ventilator and normal endotracheal tube Device: Evone ventilator and Tritube Phase 3

  Show Detailed Description

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients undergoing craniotomy will be ventilated during surgery using both conventional VCV and FVC modes. Standard baseline VCV is used for induction and stabilization of anesthesia. The order of ventilation mode is randomly assigned.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Flow Controlled Ventilation With the Evone Ventilator and Tritube Versus Volume Controlled Ventilation: A Clinical Pilot Study Describing Oxygenation, Ventilation and Haemodynamic Variables
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : August 5, 2019
Actual Study Completion Date : August 5, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Volume Controlled Ventilation
Volume Controlled Ventilation with Aisys Carestation ventilator and normal endotracheal tube'
 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
Active Comparator: Flow Controlled Ventilation
Flow Controlled Ventilation with Evone ventilator and Tritube
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Observation of systemic arterial oxygen partial pressure (PaO2) values in both ventilation modes during normocapnia (PE'CO2 35-40 mm Hg) . [ Time Frame: Following stable ventilation for 15 minutes in randomised ventilation modus, data collection starts and ends before start of surgery. ]
    Following stable ventilation for 15 minutes with respect to randomised ventilation mode, arterial blood gas will be taken.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for craniotomy in the supine position due to intracranial neoplasia
  • American Society of Anesthesiologists (ASA) Class ≤ 3
  • BMI < 30

Exclusion Criteria:

  • Respiratory disease
  • Severe cardiovascular disease
  • Non-sinus rhythm
  • Poorly controlled hypertension
  • Patients with known allergies for rocuronium, propofol or remifentanil
  • Emergency procedures
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873233


Locations
Layout table for location information
Belgium
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Layout table for investigator information
Principal Investigator: Vera Saldien, MD University Hospital, Antwerp
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Joke De Wachter, data manager, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03873233     History of Changes
Other Study ID Numbers: 18/45/512
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No