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

NCT03873233 | Completed Phase 3

• 1 other identifier: 18/45/512
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Ventilation

Outcome Measures

Primary Outcomes (1)

• Observation of systemic arterial oxygen partial pressure (PaO2) values in both ventilation modes during normocapnia (PE'CO2 35-40 mm Hg) .

  Following stable ventilation for 15 minutes with respect to randomised ventilation mode, arterial blood gas will be taken.

  Following stable ventilation for 15 minutes in randomised ventilation modus, data collection starts and ends before start of surgery.

Study Arms (2)

Volume Controlled Ventilation

ACTIVE COMPARATOR

Volume Controlled Ventilation with Aisys Carestation ventilator and normal endotracheal tube'

Device: Aisys Carestation ventilator and normal endotracheal tube

Flow Controlled Ventilation

ACTIVE COMPARATOR

Flow Controlled Ventilation with Evone ventilator and Tritube

Device: Evone ventilator and Tritube

Interventions

Aisys Carestation ventilator and normal endotracheal tube DEVICE

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

Volume Controlled Ventilation

Evone ventilator and Tritube DEVICE

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

Flow Controlled Ventilation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Respiratory disease
• Severe cardiovascular disease
• Non-sinus rhythm
• Poorly controlled hypertension
• Patients with known allergies for rocuronium, propofol or remifentanil
• Emergency procedures

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Study Officials

• Vera Saldien, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: data manager

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: March 13, 2019
• Study Start: March 15, 2019
• Primary Completion: August 5, 2019
• Study Completion: August 5, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

BE (1)