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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INTELLiVENT-ASV | Experimental | INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton. |
|
| Conventional modes | Active Comparator | Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTELLiVENT-ASV | Device | After ICU admission:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) of mechanical ventilation time in an optimal, acceptable or unacceptable ventilation zone. |
| During the first 3 hours, since admission on the ICU with the start of the intervention ventilation mode. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley De Bie Dekker, Msc | Catharina Ziekenhuis Eindhoven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Hospital | Eindhoven | North Brabant | 5623 EJ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24577110 | Background | 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. | |
| 23338569 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Intensive Care | Study Protocol | View IPD |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2018 | Nov 27, 2018 | Prot_SAP_001.pdf |
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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.
|
| Conventional modes | 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. |
|
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 |
| 32739044 | Derived | 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. |
Contact can be made to request the study protocol (Dutch) |