|- candidate number||25180|
|- NTR Number||NTR6061|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-aug-2016|
|- Secondary IDs||ARB-code NL58975.100.16|
|- Public Title||The full closed loop ventilation mode Intellivent-ASV: user-friendly and effective mechanical ventilation in high risk postoperative patients on the intensive care unit.|
|- Scientific Title||Intellivent-ASV: effective and user-friendly postoperative ventilation.|
|- Healt Condition(s) or Problem(s) studied||Ventilation|
|- Inclusion criteria||- Age above 18 years of age.|
- Informed consent.
- Body mass index of <35 kg/m2.
- Mechanical ventilation after elective surgery.
- Admission of the patient after surgery is on the high care unit of the intensive care ward for postoperative mechanical ventilation.
|- Exclusion criteria||- The patient with a 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 an other postoperative study performed on the intensive care.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||30-okt-2016|
|- planned closingdate||30-jun-2017|
|- Target number of participants||400|
|- Interventions||- The intervention group will be mechanically ventilated with IntelliVent-ASV after surgery.|
- The control group will be mechanically ventilated based on the conventional method, consisting out of pressure or volume-controlled mechanical ventilation, followed by pressure support.
|- Primary outcome||The effectiveness of IntelliVent-ASV compared to conventional mechanical ventilation:|
1. Percentage of mechanical ventilation time in an optimal, acceptable or unacceptable zone.
2. The number of successful extubations (without new intubation <48 hours) within 24 hours,
36uur and 48 hours after surgery.
3. Mechanical ventilation time to extubation measured from the time that the patient has a
temperature> 35.5 ° C.
User-friendliness of IntelliVent-ASV compared to conventional mechanical ventilation:
1. Based on the measurement of the number of interactions between the caregiver and the ventilator.
2. Survey of usability and acceptance for the caregivers.
|- Secondary outcome||The safety of IntelliVent-ASV compared to conventional mechanical ventilation:|
1. Percentage of mechanical ventilation time with an oxygen saturation <85%.
2. Percentage of mechanical ventilation time in an unacceptable zone.
Reliability of non-invasive measurements by the ventilator:
1. Comparison of the end tidal CO2 and oxygen saturation measured by the mechanical ventilator and the arterial blood gases.
2. Percentage of mechanical ventilation time with the oxygen saturation not measurable.
The patient friendliness of IntelliVent-ASV compared to conventional mechanical ventilation:
1. The number, by the caregiver, established agitated moments of the patient.
2. The number of administrations of opiates, benzodiazepines or haloperidol.
Postoperative shunting during and after mechanical ventilation:
1. The end tidal CO2 and pCO2, pO2 / FiO2 ratio in arterial blood gases; after about 1 hour, 12
hours, 24 hours, and 0.5 till 4 hours after extubation.
2. The number of patients with pulmonary atelectasis described on the X-rays of the thorax within 48 hours after surgery.
|- Timepoints||Primairy outcomes:|
1: Percentage of mechanical ventilation time in an optimal, acceptable or unacceptable zone., Timepoints: 48 hours of ventilation;
2: Successful extubations: 48 hours after surgery;
3: Mechanical ventilation time: until extubation or death.
1: Interactions with ventilator: 48 hours;
2: Survey: <24 hours after working with ventilator.
1: Oxygen saturation <85%: 48 hours of ventilation;
2: Ventilation in an unacceptable zone: 48 hours of ventilation.
1: End tidal CO2 en oxygen saturation: 48 hours of ventilation;
2: Unmeasurable oxygen saturation: 48 hours of ventilation.
- Patient friendliness
1: Agitated moments: 48 hours of ventilation;
2: Opiates, benzodiazepines or haloperidol administration: 48 hours of ventilation.
- Postoperative shunting:
1: End tidal CO2, pCO2, pO2 / FiO2 ratio: until 4 hours after extubation;
2: Postoperative pulmonary atelectasis: <48 hours after surgery.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| AJR De Bie Dekker|
|- CONTACT for SCIENTIFIC QUERIES|| AJR De Bie Dekker|
|- Sponsor/Initiator ||Catharina Hospital Eindhoven|
(Source(s) of Monetary or Material Support)
|Catharina Hospital Eindhoven|
|- Brief summary||Objective of the study:|
The aim of this study is to investigate whether postoperative ventilation with IntelliVent ASV in high risk patients, after cardio-thoracic and abdominal surgery, is as effective, more user-friendly and as safe as compared to the conventional modes of ventilation.
This is a prospective randomized study with a control group and a treatment 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.
The study population consists high risk patients after cardio-thoracic or abdominal surgery. These patients were assessed before surgery, according to protocol, to be mechanically ventilated after surgery on the high care unit of the intensive care ward, until they can be extubated.
|- Main changes (audit trail)|
|- RECORD||16-aug-2016 - 3-nov-2016|