Postoperative INTELLiVENT-ASV Ventilation

Study Overview
=================
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.

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

Conditions
-----------------
Ventilators, Mechanical, Intensive Care Units, Postoperative Care

Intervention / Treatment
-----------------
* Device: INTELLiVENT-ASV
* Device: Conventional modes


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTELLiVENT-ASV<br>INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton. | Device: INTELLiVENT-ASV<br>* 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.<br>|
| Active Comparator: Conventional modes<br>Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device. | Device: Conventional modes<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone. | An optimal zone = Tidal volume (TV) = 4-8 ml/kg of the predicted body weight (PBW) with an EtCO2 = 30-45mmHg, a plateau pressure = <31cmH2O and SpO2 = 93-98%. An acceptable zone = TV = 8-12 ml/kg of PBW with an EtCO2 = 25-30 or 45-50mmHg, a plateau pressure = 31-35 cmH2O and SpO2 = 85-93% or >98%. An unacceptable zone = TV >12 ml/kg of PBW or an EtCO2 = <25 or >50mmHg, plateau pressure >35 cmH2O or SpO2 = <85%. | During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage (%) of successful extubations. | A successful extubation is an extubation without a new intubation or the use of non-invasive ventilation within 24, 48 or 72 hours. | During the first 24, 48 and 72 hours after extubation | 
| Postoperative weaning time | The time from admission on the ICU and a temperature of >35.5°C until extubation. | 72 hours | 
| Workload | The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU. | 72 hours | 
| Usability | A survey with acceptance score (1-10) completed by the care provider at the bedside who treated the patient for the weaning | Up to 1 day after extubation | 
| Patient agitation | The number of agitated moments of the patient recognized by the ICU care provider at the bedside. | Up to 72 hours of mechanical ventilation time | 
| Administration of sedatives and analgesics | The number and dosages of administrations of NSAIDs, opiates, benzodiazepines, clonidine, propofol or haloperidol during mechanical ventilation. | Up to 72 hours of mechanical ventilation time | 
| The Richmond Agitation-Sedation Scale (RASS) | The RASS for every hour during mechanical ventilation. | Up to 72 hours of mechanical ventilation time | 
| Postoperative atelectasis | The number of a patients with an atelectasis on the first thoracic x-ray or the thoracic x-ray the following day after surgery. | Up to 48 hours after extubation | 
| CO2 levels for postoperative pulmonary shunting | The EtCO2/pCO2 ratio during mechanical ventilation. | Up to 72 hours of mechanical ventilation time | 
| O2 levels for postoperative pulmonary shunting | The pO2/FiO2 ratio during mechanical ventilation. | Up to 72 hours of mechanical ventilation time | 
| Reliability of non-invasive oxygen saturation measurement | The time of mechanical ventilation on the ICU without non-invasive measurement of the oxygen saturation. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
INTELLiVENT-ASV, Fully closed-loop ventilation, Wean