No registrations found.
ID
Source
Health condition
Intellivent-ASV ventilation mode
Fully closed loop ventilation
Conventional ventilation mode
Postoperative ventilation
Sponsors and support
Intervention
Outcome measures
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.
Background 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.
Study design:
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.
Study population:
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.
Study design
Primairy outcomes:
- Effectiveness.
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.
- User-friendliness.
1: Interactions with ventilator: 48 hours;
2: Survey: <24 hours after working with ventilator.
Secondary outcomes:
- Safety.
1: Oxygen saturation <85%: 48 hours of ventilation;
2: Ventilation in an unacceptable zone: 48 hours of ventilation.
- Reliability
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.
Intervention
- 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.
AJR De Bie Dekker
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
0031-40 239 95 00
ashley.d.bie@catharinaziekenhuis.nl
AJR De Bie Dekker
Michelangelolaan 2
Eindhoven 5623 EJ
The Netherlands
0031-40 239 95 00
ashley.d.bie@catharinaziekenhuis.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5779 |
| NTR-old | NTR6061 |
| Other | NL58975.100.16 : ARB-code |