Postoperative INTELLiVENT-ASV Ventilation (POSITiVE)

Catharina Hospital

Status

Completed

Conditions

Intensive Care Units

Postoperative Care

Ventilators, Mechanical

Treatments

Device: Conventional modes

Device: INTELLiVENT-ASV

Study type

Interventional

Funder types

Other

Identifiers

NCT03180203

NL58975.100.16

Details and patient eligibility

About

The aim of this study is to investigate whether postoperative ventilation with INTELLiVENT-ASV(adaptive support ventilation) in high risk patients, after cardiothoracic surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.

Full description

Recently, Hamilton Medical has introduced the new mechanical ventilation mode "INTELLiVENT-ASV". This is a fully closed ventilation mode that can automatically adjust the ventilation settings based on the measured End tidal CO2 (ETCO2) and the measured saturation (SpO2) in both passive and active ventilated patients. Current literature has shown that this mode is safe to use in patients admitted on the intensive care unit. A pilot study in the Catharina Hospital Eindhoven confirmed that in postoperative low risk patients on the intensive care unit INTELLiVENT-ASV is safe. Compared to continuous mandatory or pressure controlled ventilation with pressure support (conventional mechanical ventilation), INTELLiVENT-ASV is even as effective as conventional mechanical ventilation, with a significantly reduced number of interactions with the ventilator. However, available research about the effectiveness of INTELLiVENT-ASV in postoperative high risk patients is lacking. Also the knowledge about the user-friendliness of the above modes of mechanical ventilation for the users is lacking.

This is a prospective randomized study with a control group and a intervention group of postoperative high risk patients. Through randomization will be determined whether the participant, after surgery, will be mechanically ventilated with INTELLiVENT-ASV and Quickwean or with conventional mechanical ventilation.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age above 18 years of age.
Informed consent.
Body mass index of <35 kg/m2.
Mechanical ventilation after elective cardiothoracic surgery.
Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.

Exclusion criteria

Withdrawal of consent
Medical history of a pneumonectomy or lobectomy.
The patient wit acute respiratory distress syndrome after surgery.
The patient with a medical history of COPD Gold 3 or 4.
The patient is participating in another postoperative study performed on the intensive care.
The patient is, preoperatively determined, eligible for a fast-track postoperative treatment program on the Post Anesthesia Care Unit.