Postoperative INTELLiVENT-ASV Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2018-06-27

Brief Summary

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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.

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Detailed Description

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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

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Ventilators, Mechanical Intensive Care Units Postoperative Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The participant will not know which ventilation mode will be or is used. The primairy investigator and care providers are aware of which ventilation mode is used since it is not possible to blind the care providers because they will need to change ventilating parameters if necessary.

The outcome assesor for the percentages of time will be masked. Also are the radiologists, who judge the postoperative thoracic x-ray, masked.

Study Groups

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INTELLiVENT-ASV

INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton.

Group Type EXPERIMENTAL

INTELLiVENT-ASV

Intervention Type DEVICE

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.

Conventional modes

Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device.

Group Type ACTIVE_COMPARATOR

Conventional modes

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No