NCT04306757

Brief Summary

This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure controlled ventilation in cardiac surgery requiring cardiopulmonary bypass.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 6, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

March 10, 2020

Last Update Submit

March 22, 2021

Conditions

Respiration; ArtificialPositive-Pressure Respiration

Keywords

flow controlled ventilationpressure controlled ventilationcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Horowitz Index

    arterial partial pressure of Oxygen (paO2) / fraction of inspired Oxygen (FiO2)

    15 minutes after chest closure

Secondary Outcomes (1)

  • lung tissue aeration

    immediately postoperative

Study Arms (2)

FCV

EXPERIMENTAL

Artificial ventilation will be performed with individualized flow-controlled ventilation (Evone, Ventinova Medical B.V., Eindhoven, the Netherlands) during cardiac surgery until admission to postoperative ICU. Individualisation will be established by compliance guided end-expiratory and peak pressure setting, flow setting will be adjusted to secure normocapnia and I:E Ratio set to 1:1.

Device: Evone

PCV

ACTIVE COMPARATOR

Artificial ventilation will be performed with low tidal volume pressure-controlled ventilation (Primus, Dräger, Lübeck, Germany) during cardiac surgery until admission to postoperative ICU. Peak pressure will be set to achieve a tidal volume of 7ml/kg predicted body weight at a compliance titrated positive end-expiratory pressure. Respiratory rate will be set to maintain normocapnia and I:E ratio set to 1:1.5 except extension of expiration is necessary in order to avoid air trapping.

Device: Primus

Interventions

EvoneDEVICE

Airway ventilation device

FCV
PrimusDEVICE

Airway ventilation device

PCV

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects \>18 years
  • Body weight \>40 kg
  • Elective cardiac surgery with CPB and without ventilation during CPB
  • American Society of Anaesthesiologists (ASA) risc classification I-IV
  • Written informed consent

You may not qualify if:

  • Emergency surgery
  • Female subjects known to be pregnant
  • Known participation in another interventional clinical trial
  • High risk cardiac surgery such as double valve surgery, re-cardiac surgery, intraoperative cardiac arrest or pre-existing high grade cardiomyopathy (ejection fraction \<30%)
  • Closing operation field without chest closure due to hemodynamic instability
  • Acute endocarditis under antibiotic treatment
  • Minimal invasive valve surgery via thoracotomy (MIC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

  • Schmidt J, Wenzel C, Mahn M, Spassov S, Cristina Schmitz H, Borgmann S, Lin Z, Haberstroh J, Meckel S, Eiden S, Wirth S, Buerkle H, Schumann S. Improved lung recruitment and oxygenation during mandatory ventilation with a new expiratory ventilation assistance device: A controlled interventional trial in healthy pigs. Eur J Anaesthesiol. 2018 Oct;35(10):736-744. doi: 10.1097/EJA.0000000000000819.

    PMID: 29734208BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Judith Martini, MD

    Medical University Innsbruck, Dept. of Anaesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: controlled, prospective
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2020

First Posted

March 13, 2020

Study Start

March 6, 2020

Primary Completion

March 2, 2021

Study Completion

March 2, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)