NCT03180203

Postoperative INTELLiVENT-ASV Ventilation

The Full Closed Loop Ventilation Mode INTELLiVENT-ASV: User-friendly and Effective Mechanical Ventilation in High Risk Postoperative Patient on the Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilators, Mechanical
• Intensive Care Units
• Postoperative Care

Interventions

Type	Name	Description
DEVICE	INTELLiVENT-ASV	After ICU admission: * The first three hours: only ventilation with INTELLiVENT-ASV with Quickwean. * After three hours: Automatic spontaneous breathing trials (SBT) is activated and SBT starts if \>10minutes PEEP:\<9cmH2O,FiO2:\<41%,VT/IBW\<5ml/kg and RSB:\<106l/l\*min. Settings SBT are MV% 25%,PEEP 5cmH2O.SBT automatically stops if respiratory rate \>35b/min or increases \>100% since start of SBT, FiO2 \>50%, PeTCO2 increases \>8mmHg. Extubation criteria: Leakage \<50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT \>10min. If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT.
DEVICE	Conventional modes	After ICU admission: The first three hours: only ventilation with CMV or PS. If required care providers may change the mode to adaptive support ventilation. After three hours: manual SBT is required if \>10min PS\<11cmH2O,PEEP\<9cmH2O,FiO2\<41%. Settings SBT are PS 5cmH2O, PEEP 5cmH2O, FiO2 30%. SBT must be stopped if respiratory rate \>35b/min or increases \>100% since the start of SBT, saturation \<92% or the PeTCO2 increases \>8mmHg. Extubation criteria: Leakage \<50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT \>10min. If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT.

Timeline

• Start date: 2017-05-22
• Primary completion: 2018-05-01
• Completion: 2018-06-27
• First posted: 2017-06-08
• Last updated: 2018-11-29

Locations

1 site across 1 country: Netherlands