Clinical trial NCT03180203: Postoperative INTELLiVENT-ASV Ventilation
Official title: The Full Closed Loop Ventilation Mode INTELLiVENT-ASV: User-friendly and Effective Mechanical Ventilation in High Risk Postoperative Patient on the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilators, Mechanical
Intensive Care Units
Postoperative Care
Keywords: INTELLiVENT-ASV
Fully closed-loop ventilation
Wean
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2017-06-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone.
timeFrame: During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode.
Secondary outcomes:
measure: The percentage (%) of successful extubations.
timeFrame: During the first 24, 48 and 72 hours after extubation
measure: Postoperative weaning time
timeFrame: 72 hours
measure: Workload
timeFrame: 72 hours
measure: Usability
timeFrame: Up to 1 day after extubation
measure: Patient agitation
timeFrame: Up to 72 hours of mechanical ventilation time
measure: Administration of sedatives and analgesics
timeFrame: Up to 72 hours of mechanical ventilation time
measure: The Richmond Agitation-Sedation Scale (RASS)
timeFrame: Up to 72 hours of mechanical ventilation time
measure: Postoperative atelectasis
timeFrame: Up to 48 hours after extubation
measure: CO2 levels for postoperative pulmonary shunting
timeFrame: Up to 72 hours of mechanical ventilation time
measure: O2 levels for postoperative pulmonary shunting
timeFrame: Up to 72 hours of mechanical ventilation time
measure: Reliability of non-invasive oxygen saturation measurement
timeFrame: 72 hours
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Ashley De Bie Dekker, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beijers AJ, Roos AN, Bindels AJ. Fully automated closed-loop ventilation is safe and effective in post-cardiac surgery patients. Intensive Care Med. 2014 May;40(5):752-3. doi: 10.1007/s00134-014-3234-7. Epub 2014 Feb 28. No abstract available.
citation: Lellouche F, Bouchard PA, Simard S, L'Her E, Wysocki M. Evaluation of fully automated ventilation: a randomized controlled study in post-cardiac surgery patients. Intensive Care Med. 2013 Mar;39(3):463-71. doi: 10.1007/s00134-012-2799-2. Epub 2013 Jan 22.
citation: De Bie AJR, Neto AS, van Meenen DM, Bouwman AR, Roos AN, Lameijer JR, Korsten EHM, Schultz MJ, Bindels AJGH. Fully automated postoperative ventilation in cardiac surgery patients: a randomised clinical trial. Br J Anaesth. 2020 Nov;125(5):739-749. doi: 10.1016/j.bja.2020.06.037. Epub 2020 Jul 30.