Postoperative INTELLiVENT-ASV Ventilation
- Conditions
- Intensive Care UnitsVentilators, MechanicalPostoperative Care
- Interventions
- Device: INTELLiVENT-ASVDevice: Conventional modes
- Registration Number
- NCT03180203
- Lead Sponsor
- Catharina Ziekenhuis Eindhoven
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTELLiVENT-ASV INTELLiVENT-ASV INTELLiVENT-ASV is a full closed-loop ventilation mode,available on the mechanical ventilator S1 of Hamilton. Conventional modes Conventional modes Volume controlled continuous mandatory ventilation (CMV) mode with pressure support mode on the Hamilton S1 Device.
- Primary Outcome Measures
Name Time Method 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. * 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%.
- Secondary Outcome Measures
Name Time Method The percentage (%) of successful extubations. During the first 24, 48 and 72 hours after extubation A successful extubation is an extubation without a new intubation or the use of non-invasive ventilation within 24, 48 or 72 hours.
Postoperative atelectasis Up to 48 hours after extubation The number of a patients with an atelectasis on the first thoracic x-ray or the thoracic x-ray the following day after surgery.
Administration of sedatives and analgesics Up to 72 hours of mechanical ventilation time The number and dosages of administrations of NSAIDs, opiates, benzodiazepines, clonidine, propofol or haloperidol during mechanical ventilation.
O2 levels for postoperative pulmonary shunting Up to 72 hours of mechanical ventilation time The pO2/FiO2 ratio during mechanical ventilation.
Postoperative weaning time 72 hours The time from admission on the ICU and a temperature of \>35.5°C until extubation.
Workload 72 hours The number of alarms and required interactions between the ventilator and the user during mechanical ventilation on the ICU.
The Richmond Agitation-Sedation Scale (RASS) Up to 72 hours of mechanical ventilation time The RASS for every hour during mechanical ventilation.
CO2 levels for postoperative pulmonary shunting Up to 72 hours of mechanical ventilation time The EtCO2/pCO2 ratio during mechanical ventilation.
Reliability of non-invasive oxygen saturation measurement 72 hours The time of mechanical ventilation on the ICU without non-invasive measurement of the oxygen saturation.
Usability Up to 1 day after extubation A survey with acceptance score (1-10) completed by the care provider at the bedside who treated the patient for the weaning
Patient agitation Up to 72 hours of mechanical ventilation time The number of agitated moments of the patient recognized by the ICU care provider at the bedside.
Trial Locations
- Locations (1)
Catharina Hospital
🇳🇱Eindhoven, Noord-Brabant, Netherlands